CAPA Reply For Audit Findings-29DEC2022

CAPA Reply for Audit Findings
Intercompany Audit Number ICA- - 00- 0000

From 07 to 10 MAR 2022
Audit Date
aCompany SAFE Pharma
Please find enclosed the audit report listing the deficiencies made during the audit. The facility should take the information provided in
this report as examples and to perform both vertical and horizontal analysis of the issues that the specific deficiencies raise. Such analysis should
be used to assess the extent of the underlying deficiency that has resulted in the specific examples cited, and their impact on other areas, if
applicable. In addition, deficiencies described in this report that are designated to be of less severity, may increase in severity if not satisfactorily
addressed in a timely manner.
Please submit a response to the audit report detailing the root cause analysis and proposed corrective action plans (CAPAs) for (Critical
and Major) deficiencies, including the completion dates or anticipated completion dates for completion of these actions. For all major deficiencies
the company’s response should include supporting documented evidence that these actions have been or will be undertaken. The response should
reach the inter-company audit team within 30 calendar days from the date of this letter.
The response should incorporate the following information in the format outlined in Table 1
below:
a) Root cause analysis (how/why did this happen?) and analysis regarding related areas (is this same or a similar issue
impacting/occurring elsewhere?);
b) Correction (fix now, to eliminate the nonconformity) and corrective action (to prevent recurrence), where applicable with planned
completion dates;
c) The steps that have or will be taken for the demonstration of effectiveness of the actions taken.
Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

The steps that
Root cause have or will be
Assessment by
analysis Correction and proposed taken for the
Timeline
inspector
(Additional corrective action demonstration
Observations information (Additional information may of
may be be attached as annexes) effectiveness
attached as of the actions
annexes) taken
A. Quality Management System
1. Critical
1.1 N/A
1.2 N/A
2. Major
Site Master File (SMF) Deficiency Creating SOP for SMF Done
A. Approval list was prepared by & approved by should be in the critical initiation according to several
created by, revised by& approved by review for references including pics. And
B. SMF does not comply with SMF template in PIC/s guideline, the updated Changing the site master file
e.g. it was missing guidelines according to this SOP to
2.1.  list of toll manufacturing. against our include the critical review and
 list of the outsourced lab. system. also include:
 list safe pharma products  list of toll manufacturing.
 list of major equipment separated into each department.  list of the outsourced lab.
 list safe pharma products.
 list of major equipment
separated into each department.
Context of Organization Deficiency The quality manual will be 01/2023
A. Quality manual has many defects and should be canceled as in the critical cancelled and the SOP context
the SMF and context of the organization replace it. review for (QOP-00-001) will be updated
B. Context of Organization is described in the SOP instead of the updated to include record for the
being recorded in the context of the organization template & guidelines context of the organization.
records. against our
system.
2.2.
2.3. Batch release process was deficient in that by reviewing SOP & Insufficient - SOP of batch released was Done
batch record (Royal Jelly 600 mg SG capsules, B.N. 221413). implementati updated to include: - A list
A. List of qualified persons (QP) was not in place. on of of qualified persons and
B Certificate of conformity (COC) was not implemented. updated Check list of batch

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Release label on finished goods (FG) was attached in one side guidelines. documentation.
only not in four sides which may lead - SOP for COC will be
to missing status of FG. initiated for toll products and 01/2023
D. Check list of batch documentation components is missing. the toll manufacturer will be
E. Accountability of reject store belongs to warehouse not QA. informed by the new system. 01/2023
- For the released label,
printer (Zibra) will be
purchased.
- SOP reject store will be 01/2023
updated to include the
responsibility of QA.
2.4 Good Documentation Practice
By reviewing batch record (Royal Jelly 600 mg SG capsules, B.N. 221413)
A. Validity date for batch record is not defined. Human error - The archiving SOP was Done
B. Cross-outs was found in batch record signed without dates. due to lack updated to include validity
C. Missed signatures in dispensing page printed from oracle. in training date for batch record is one
D. Several overwriting in batch record & complaint report (Hi-Vit on updated year after expiry.
complaint # 03-2021). guidelines. - The BPR will be updated to 01/2023
E. Availability to fill extra data in some pages in batch record, be more comply with WHO
some areas were not closed. requirements.

The steps that
Assessment by
Timeline
inspector
annexes) taken
F. SOPs were made effective after 30 days of issuing, there was - Re-training has been done
no mentioning of assuring that training was conducted in that for the production operator
period. and supervisor on
GDP.Training record will be
reviewed by lead to assure
that all in charge person
signed on training and held
an challenge to assure the
effectiveness of training
Customer Complaints
By reviewing SOP # QSOP-04-008 & example: Hi-Vit # 03-2021, B.N. 211878 to 211887 (Mfg. date:
05/2021, Exp. Date: 05/2024) it was found that:
A. SOP didn’t mention the adverse events situation and Deficiency Updating customer complaint 12/2022
pharmacovigilance role. in the critical SOP to include
B. Systematic way of root cause investigation (Tools) was not review for - adverse events situation and
followed. the updated pharmacovigilance role.
2.5 C. There was no periodic trending of customer complaints guidelines -a way for root cause analysis
according to root cause & SOP was missing to define recurrence against our - periodic trending of customer
D. Both acknowledgment letter and customer response form were system. complaints
missing in the SOP. - acknowledgment letter and
E. Investigations were not extended to other batches, products or customer response
machines. -investigation extended to other
batches, products or machines.
2.6. Internal Auditing

By reviewing SOP QSOP-00-004 & internal auditing plan for 2021 & 2022; it was found that:
A. Frequency of internal auditing runs was not defined based on Deficiency Updating internal audit to 12/2022
risk assessment. in the critical include:
B. Shifting of internal audit plan from Feb. 2022 to Mar.2022 was review for
done without justification. the updated -risk assessment for audits runs

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Missed runs in 2021 plan without issuing deviation to identify guidelines -justification form in case of
root cause and CAPA to prevent recurrence. against our plan shifting
D. Target reporting and response time for reply was missing in system.
the SOP. -following up CAPA for audit
finding
Supplier Qualification Deficiency Updating Supplier qualification Done

A. There were no specific criteria for the requirements of supplier in the critical SOP to include:
approval according to the class of the supplier review for
B. Purchasing manager have joint responsibility with the QA the updated - specific criteria for supplier
manager for supplier approval guidelines approval
C. There was no Quality Agreements with the suppliers of against our
materials nor services system. - justification for the rating of
suppliers
2.7. D. There was no justification for the rating of suppliers nor
evidence for the score given by other department participating in
the evaluation
E. SOP for service supplier qualification had in its scope services
that are not critical to quality, like transportation while services
which are critical to quality like distribution are not covered.

The steps that
Assessment by
Timeline
inspector
annexes) taken
NCR Management Deficiency Updating NCR SOP to include
by reviewing SOP# QSOP-04-014 & NCR log it was found that: in the review New system format, A system
A. All deviations (44 deviations) were issued by QA. for the for classification systematic,
B. Current SOP was conflicting with the updated NCR software updated investigation tool for root cause
system. guidelines analysis, all evidences shall be
C. There was no system for the classification of NCRs nor against our attached with NCR
differentiations between the handling of other, major and critical system with
NCRs lack in
D. There was no provision for the notification of Tolling training.
Companies in case of NCR that can affect the quality of toll
products
E. There were no specific instructions for the use of investigation
tools
F. There was no adequate impact assessment to assure that
products and processes are not impacted by the NCR
G. Evidence for the non-conformity was not included (Phase 1
investigation was attached without the actual COA)
H. Root cause analysis was not detailed, factors which could be
identified as root cause was not assessed nor investigated
I. There were a recurrent OOS in water treatment plant which
identified the root cause as a replacement for the entire water
treatment plant with no impact assessment to assure that
processes and products are not affected and no planned CAPA
J. Environmental monitoring microbiological Test incubation
period was noticed to be 3 days instead of 5 days without 12/2022
2.8 justification
K. Warehouse refrigerator was sampled for environmental
monitoring as Class D while the layout didn’t identify the area as
classified.

The steps that
Assessment by
Timeline
inspector
annexes) taken
Risk Management system was deficient in that
Risk assessment of Alphacalcidol was issued 27/02/2019 did not address the following:
A. Control of medicine dispensing didn’t clarify use of the mask Deficiency The risk will be revisited to
while material is very toxic for inhalation in the critical include: -
B. Control of HVAC system was not addressed in the risk review for
C. Impact on females as the material may cause harm for unborn the updated A. Control of medicine
2.9 baby guidelines dispensing as use of the mask
against our while material is very toxic for Q1/2023
system inhalation.
B. Control of HVAC system.
C. Impact on females.
2.10 Change control system was deficient in that

By Reviewing CCR No. 24/21 for introducing of new
Alphacalcidol product the following were deficient:
A. Using name & form number for Pharco Pharmaceutical CCR Deficiency A request to change (company Q1-2023
reports not Safe Pharma in the critical name, logo and form codes)
review for was sent to the corporate IT
the updated directory corporation IT to
guidelines
against our
system

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. The description, status, proposed change & reason for change The we performed many training -------
were the same statement electronic sessions with various
system then departments after this incident
was new and to solve this case
the staff of
safe pharma
wasn't
C. Some of the committee departments e.g. (production, trained
Actually well Contact with corporation IT to Q1/2023
microbiology& QA compliance) the data was recorded & this is let record done with a level and
reviewed by the same person considered revision done with higher level
as a defect in
the system
itself , as a
data integrity
concept the
system
shouldn't
allow the
D. QA compliance stated that they will not be impacted with the same person The raw material supplier will
Deficiency Q1/2023
change while they should address the qualification of the RM in the critical be considered in Supplier
suppliers for the new product review for qualification.
the updated
guidelines
against our
system

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. QA validation did not address the impact of the change on the Deficiency Will be produced on a Q2/2023
cleaning validation study in the critical dedicated line (before the
review for initiation of the change request)
the updated
guidelines
against our
system
F. The impact assessment stated that stability study should be Human Q2/2023
addressed for the new product while the action plan for the CCR error due to A stability study will be
did not contain action for doing stability study deficiency of considered for new CCR for
reviewing new products
the impact
assessment
before taking
G. EHS consideration was not addressed in the CCR while the Deficiency EHS will be notified for all Dec -2022
product was toxic & potent in the critical new CCRs to give a feed pack
review for in case there was a health effect
the updated due to that change
guidelines
against our
3. Other
3.1 Organization & Management was deficient in that Deficiency in A finger print access will be Done
A. Access to the laboratories is not controlled. [QC, the critical installed on entrance door for
microbiology & R&D] review for the more access control
updated
guidelines
B. The identification labels/codes for QC/R&D & many of QC & Deficiency Adding ID labels for loops or 12/2022 `
R&D rooms and corridors are not present. in the critical instrument and codes for areas
review for
the updated
guidelines
against our

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. No delegation sheet [R&D]. Deficiency delegation sheet will be done Oct 2022
in the critical
review for
guidelines
QHSE Policy Deficiency SOP for policy will be issued Oct 2022
A. QHSE policy need to be updated to match corporate QHSE of the following corporation formats
policy once issued. review for
The policy is not related to SOP, no statement for periodic review the updated
of the policy. guidelines
against our
3.4 system
Company Profile Deficiency Company profile will be Q1/2023

A. Should be updated to match corporate company profile in the critical updated following Corporation
procedure once issued. review for formats
Several typo mistakes were noted in the presentation including guidelines
names of products
3.5
Training lack of Attending TOT training (Corp Done

A. Lack of on-job training for QA staff who are responsible for training training), receiving corporation
training personnel in other departments on GMP practices. material not material
3.6 trainers

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. Absence of QA role in OOS investigation according to SOP L- Deficiency A Updating L-SOP-00-008 to Q1/2023
SOP-00-008. in the critical include QA role
B. Very weak following up practices for QA & QC inspectors review for
during blistering and cartooning; Whereas guidelines B new hiring request sent to
the operators bypass the sensors action HR to avoid shortage in B Done
Shortage in manpower
man power
3.7
Recall Deficiency Updating SOP QSOP-00-006 02/2023

By reviewing SOP QSOP-00-006, it was found that: of the to include :
A. Mock recall was not performed during 2020 & 2021 while review for
stated in the SOP that it should be conducted annually. the updated -criteria of mock recalled
B. Access of recalled area belongs to warehouse not QA. guidelines products
3.8 C. Selection criteria of Mock recalled batch was not stated in the against our
SOP. system
Job Description Updating SOP HSOP-03-002 01/2023
By reviewing Job description SOP: HSOP-03-002 effective date to include :
24.06.2021 & Training SOP # HSOP- Deficiency
02-001 it was found that: of the - reporting role of QA Manager
A. There was no clear reporting role of QA Manager regarding review for regarding CEO & Corp. QHSE
3.9 CEO & Corp. QHSE Director. the updated Director.
B. Delegation policy is not in place (under issuing.) guidelines
against our

The steps that
Assessment by
Timeline
inspector
annexes) taken
Management Review Deficiency Updating SOP QSOP-00-002 Dec 2022
By reviewing SOP QOP-00-002 effective date: 1/11/2018 and in the critical to include :
management meetings conducted in 2020 & 2021, It was found review for Risk assessment for over due
that: guidelines date
A. Meeting was conducted on 22/03/2020 & 24/06/2021 instead
of Jan. to set the objectives of the year.
B. No action was taken in case of exceeding the planned due date,
extension should be covered with risk
assessment (BMS upgrade, Encapsulation machine upgrade,
3.10
increase storage capacity in warehouse).
Risk Management system was deficient in that Deficiency Updating SOP to include : Q1/2023
A. SOP for risk management QSOP-00-003 stated that risk in the critical -Action plan to follow the
review done by QA but the SOP did not review for implementation of actions
contain any forms for risk review and by reviewing risk register guidelines
for production found that
 All risks were issued since 2018
 The revision was done on 12/07/2020 and 09/12/2021 without
adding any new required risk
assessment although risk assessment for adding new product
Alphacalicidol was issued and not added to risk register nor
addressed in the revision that was done
3.11 B. Risk assessment forms did not contain action plan to follow
the implementation of required mitigation actions.
4. Comments
Management of resources was deficient in that Hiring new employee Done
Manpower is not enough in PM
4.1
B. Facilities/Equipment/ Manufacturing
1. Critical

The steps that
Assessment by
Timeline
inspector
annexes) taken
1.1. Computerized Systems Deficiency A risk assessment will be Q1/2023
There is a risk throughout the lifecycle of the computerized of data issued including:
system taking into account data integrity and product quality, for integrity
example: practice -Sharing of password
A. Sharing of passwords in
 General PCs Account.
 Raman Instrument.
 Only the admin account is used in UV instrument.
 Oracle system shows the name of (Sampled by) differing from
that of (sent by), although he is the same person. [QC]
B. Use of generic user access for HPLC Code: RDM 05-1 which Deficiency HPLC will connected to Q1/2023
is in the critical empower system
 Not connected to empower server. review for Adding more user for HPLC
 With no privileges. guidelines access
 Used by one user only [System R&D]
C. Privilege list is not created for Deficiency Privilege list will be created to Q1/2023
 The new FTIR. of data include :
 Atomic absorption instrument. [QC] integrity The new FTIR
D. All balances present in QC (Like INRM-42) are not... practice Atomic absorption instrument
 Secured nor password protected. Balanced will be connected to
 Date and time can be easily changed by the analyst. system to be :
which is a violation from data integrity practice [QC & R&D] Secured and block changing in
E. Time synchronization was not applied for Raman instrument time or date
where the screen shows the year of 1970. [QC] Time synchronization will be
applied for Raman instrument
F. Computer was locked after 10 minutes of inactivity, which can Deficiency Changing systematic logout Q1/2023
be misused. [QC & R&D] of data time to be 3 minutes as
integrity maximum

The steps that
Assessment by
Timeline
inspector
annexes) taken
practice
G. Balance Code: RMD 02-1 printer was Deficiency Balance printer paper will be Q1/2023
 Temperature sensitive. in the critical available
 Out of paper (from a long time ago). [R&D] review for
guidelines
H. Routine reviews of data & metadata did not include Audit Deficiency Will be consider to all of this Q1/2023
trails (empower3 training is required) also in the critical issue
periodic audit trail review was not applied. review for
example: The printed chromatograms were not reviewed against guidelines
electronic records & audit trail &
the lab did not know some types of audit trails like system audit
trail plus comments was not detailed
in audit trail (Ca-D pantothenate chromatograms in RM). [QC &
R&D]
I. According to SOP: LSOP-03-014 daily backup on DVD& Deficiency DVD will be available for Q1/2023
monthly backup on DVD were sent monthly to IT which was not of data monthly backup
done in labs where PCs does not contain DVD writer so there is integrity
no backup of data. [QC & R&D] practice
J. According to SOP: ISOP-03-014 Deficiency Will be considered Q1/2023

Report for time/ date synchronization should be done by labs that of data
were not implemented for standalone PCs Like UV. [QC & integrity
R&D] practice
K. Excel sheets used for calculations were not validated nor Deficiency Excel sheet will be validated , Q1/2023
secured or protected, also the analyst of data and be secured to prevent edit
performs rounding of initial readings which is a violation of GMP integrity on sheet forms
and may lead to wrong results. Data logger records were saved in practice
editable excel sheet forms which can be manipulated easily, the

The steps that
Assessment by
Timeline
inspector
annexes) taken
form was not secured nor protected from manipulation. [QC]
L. COA was issued & reviewed before reporting HPLC Deficiency Will be considered Q1/2023
Chromatograms [QC] of data
integrity
practice
2. Major
Computerized Systems Deficiency -Inventory list will be issued Q1/2023
A. No inventory list was issued for the computerized systems of data -Issuing CSV plan
B. No CSV Plan was issued integrity
C. Back up & restore SOP# ISOP-02-002 stated that monthly practice
backup is done & recorded in form No.
2.1. ISOP-02-002-01 & copy of backup should be stored in a Bank
which was not implemented
3. Other
3.1. Data traceability were deficient in that WHO Technical Deficiency A . Live sign will be Done
A. Label Forms were not live signed (for example, labels of of data considered
reagents when traced, it was noticed that integrity
the supervision that was done in the logbook of preparation was practice
different than that written on the
label, also the analyst’s name was not written correctly), also
opening of chemicals used by the
lab. were not signed, only a date was written on the label but with
no traceability to the person that opened it. [QC]
B. In samples receipt record the item for (Done by) was not
referring to the analyst that had done the
analysis, thus the column was with no meaning, in addition to in
sufficient information to trace the product analysis in lab. B . The form will be changed B . dec
Logbooks, also no check for samples (status, quantity) was done /2022
prior to receiving and analysis. (SOP: LSOP-00-017, named
"handling of QC samples”) (taking Gynozol evag. suppository as C . a training on document

The steps that
Assessment by
Timeline
inspector
annexes) taken
an example batch: 2214290225, received in 24/02/2022). [QC] control is held Done
C. Logbook no. of the analyst was written wrongly in the COA as D . a receipt record will be
22009/83, while after revising the initiated 12-2022
raw data from logbooks it was found to be 22008/83 (typing E . vial will be numbered
mistake). [QC] 12-2022
D. Reference standards purchased and received by documentation
section were delivered to the lab
with no evidence, no receipt record was present for such activity.
[QC]
E. Vials prepared for working standard was not numbered and
thus are not easily traced if OOS is Present.
4. Comments
4.1. N/A N/A N/A N/A N/A N/A
4.2. N/A N/A N/A N/A N/A
C. Purified Water Station
1. Critical
A. As mentioned by the microbiology lab lead, the PQ of the Water A .Changing disinfectant A .Done
water treatment plant failed microbiologically and is still used. station is old concentration to avoid non -
B. The purified water station was unqualified and should be design &in conformity
replaced efficient
B .Waiting for new water B .Q4/202
station (issuing purchasing 3
request)
1.1.
2. Major

The steps that
Assessment by
Timeline
inspector
annexes) taken
2.1. retreatment water station was deficient in that Deficiency SOP will be initiate for : Dec 2022
A. There were No. SOPs for (filters, Softeners & ROunit) of review of (filters, Softeners & R Ounit)
 Operation GDP  Operation
 Regeneration & Back wash knowledge  Regeneration & Back wash
 Sanitization & Chemical Cleaning  Sanitization & Chemical
 Preventive Maintenance Cleaning
 Preventive Maintenance
B. There were No logbooks or log sheets for (Regeneration, Back A log book for Regeneration, Dec 2022
wash, Sanitization & Preventive Back wash, Sanitization &
Maintenance) Preventive will be initiate
Deficiency
of review of
C. There were no SOPs for Chemical preparation and Chemical GDP SOP will be initiate for Dec 2022
tank cleaning knowledge Chemical preparation and
Chemical tank cleaning
D. There were no SOPs for filter Replacement Deficiency SOP will be initiated for filter Dec 2022
of review of Replacement
GDP
knowledge
E. Pressure gage no. P 12, reading was 1.4 P while the standard Human error it was during softner
range is 2-6 P without any investigation or comments. due to regeneration which is normal
deficiency in
reviewing of
standard
F. There was no pressure gauge after 5 μ filter --------------- Clarified during audit Done
G. No chemical certificate or QC release for used Sodium Water a certificate will be issued for Q3/2023
Metabisulfite or used chemicals. station is old used Sodium Metabisulfite or
design &in used chemicals. Waiting for
efficient new PO

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. Pre-treatment Water station chemical sanitization performed Water will be covered for new water Q4/2023
every year and not based on risk assessment (it should be station is old station
performed every 3 months) design &in
efficient
I. Chlorine tank was not identified Human Identification label installed Done
error due to for
deficiency of Chlorine tank
following
Water Q4/2023
station is old
design &in
efficient A PQ will be performed upon
micro lab upgrade
2.2 No PQ for Pre-treatment Water Station
3. Other
3.1. A. Washing of Main Tanks were performed annually, it is According to ------------------------------- ----------
recommended to be every 6 months risk
assessment
there is no
need to be
every 6
months
B. No washing cycle for treatment tank 5 m3 it is recommended Human SOP will be issued , Washing 12/2022
to be washed every 3 months error due to cycle will be considered to be
deficiency of every 3 months
following
GDP

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Chlorine dosing for Treated tank performed continuously Water Sensor will be installed Q2-2023
without sensor for determining the concentration (should be with station is old purchasing request issued for
sensor) design &in automatic one
efficient
D. Chlorine injection unit did not appear on the layout& the Done
layout missed signatures (Eng. Radwa- Eng.
Mohamed Saeed)
E. The daily follow up logbook was not controlled, serialized, nor Done
pounded
4. Comments
N/A N/A N/A N/A N/A N/A
4.1.
D. Validation & Qualification

1. Critical
Cleaning Validation Protocol (QP-05-001) was deficient in
1.1.

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. Being prepared in 2018, However the study was implemented Deficiency Study was performed in 2014, -------------
in 03/2014. in the critical then a recalculation in the -
review for report considering the recovery
guidelines factor was done in 2018
B. Uses different scoring technique in worst case selection than Deficiency Scoring will be done according Q2 -2023
the stated one in the CV SOP. in the critical to : 1-solublity
review for 2-formulation risk (clean-
guidelines ability)
3-lowest human therapeutic
dose
4- toxicity (LD50)
C. No toxicity consideration for products matrix nor MACO Deficiency Toxicity products will be Q2 -2023
calculations. in the critical considered
review for
D. Cleaning procedures referred in relative SOPs are very guidelines
Human error A detailed procedures to be Q1/2023
shallow with no specified cleaning parameters which can be due to added to SOP i.e. cleaning
followed regularly in routine cleaning procedures. deficiency of parameters and cleaning
reviewing methods
guidance

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. Current number of Products processed on the manufacturing Deficiency More products will be Q2 -2023
line is 52 products, however the products matrix included only 22 in the critical considered
products for worst case selection. review for
guidelines
F. Not all categories of machines were involved in the study, Deficiency All machines categories will Q2 -2023
Where they need a specific studies (Medicine Mixers – Powders in the critical be considered
Mixers – Discharge Pumps – Gelatin Preparation Mixers & review for
Utensils – capsules Sorting Machines – Capsules Polishers – guidelines
Capsules Printers – Blistering Machines – Hobart Washer –
Vacuum Pumps – Capsules Counter – Capsules Capping –
Dispensing Booth – Sampling Booth & Tools).
G. Campaign Length – DHT – CHT wasn’t implemented. Deficiency written procedures to be Done
in the critical written for implementation of
review for Campaign Length – DHT –
guidelines CHT
H. Cleaning Validation report has no code Deficiency To be coded according to the Q2 -2023
in the critical new coding system in the SOP
review for
guidelines
. Micro results were failed in 03/2014, were revalidated on It was done -------------------- -------------
another product in 11/2017, Where during this period the line was in 2014 not
microbiologically contaminated. 2017 while
the date
(11/2017) is
the date of
report re-

The steps that
Assessment by
Timeline
inspector
annexes) taken
K. No version control for CV protocols & reports Human A new coding system will 12-2022
error due to consider Waiting for new DC
deficiency of system
following
L. No Variations/Deviations section in the report Human To be added to report Q2 -2023
error due to
deficiency of
Autoclave Qualification was deficient in following
Human will change the protocol and 01/2023
A. Number of data loggers used was 5, which should be at least error due to autoclave
10 DLs. deficiency of
B. Only 1 cycle of distribution & 1 penetration was implemented, reviewing
where they should be 3 cycles at guidelines
each load configuration.
C. Load configuration should be clarified on the diagram.
D. Temperature set point should be at least 121o C for 15 minutes
not 120.
E. No biological indicators were used to verify the lethality factor
1.13.
of the autoclave.
2. Major
2.1. Validation Master Plan SOP (QSOP-05-005) was deficient in that
A. It didn’t mention Retrospective Validation even for Human error Retrospective Validation will Q1-2023
exceptional cases. due to be excluded in the new version
deficiency of of SOP
reviewing
B. Validation Phases were described incorrectly, should be guidelines
Human It will be modified in the new Q1-2023
(Design – Process Performance error due to version
Qualification – Continued Process Validation). deficiency of
Revalidation cases shall be

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Stated that frequency of revalidation for products is based reviewing considered
upon risk assessment study which is not guidelines
implemented.
D. Didn’t contain approved plans Human It will be considered in the new Q1-2023
error due to version
deficiency of
reviewing
guidelines
Process Validation SOP was deficient in

A. For (CV – HT – CSV – AMV – Qualification for Equipment Human Updating SOP to include : Done
& Systems – Calibration – Preventive Maintenance – Supplier error due to CV – HT – CSV – AMV –
Qualification). deficiency of Qualification for Equipment &
reviewing Systems – Calibration –
guidelines Preventive Maintenance –
B. No tracker forms for plans implementation which should Supplier Qualification). Q1-2023
include actual dates of implementation, - tracker forms for plans
Remarks column & QA review, and approval on monthly or implementation
quarterly basis.

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Some items of PV plan 2021 wasn’t implemented with no Actually the Done
justification. plan is
usually
initiated
according to
forecasting
as Safe
Pharma is
mainly a toll
manufacturi
ng site and
the
production
plan can be
changed
D. Pages serial was hand-written in pages. many
Human times Serializing pages will be done Dec 2022
error due to using a stamp Waiting for new
deficiency of DC system
knowledge
E. No control on pages of forms by stamp. for GDP Done Done
F. Named (Concurrent Production Process Validation), So there Human Name of SOP will be changed Done
was no mention nor implementation of Prospective PV Studies. error due to to process validation
deficiency of
G. Revalidation cases didn’t include (Change in Batch Size). reviewing It will be considered in the new Done
guidelines version and to refer the SOP of
SUPAC

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. Stated that frequency of revalidation was based upon risk Risk assessment will be Done
assessment study which was not implemented. performed to cover this point
I. No distinctive coding system for PV protocols & reports. It will be considered in the new Dec 2022
version of SOP Waiting for
new DC system
2.3. Process Validation Protocol for Omega Alex 3-6-9 (PV-627-01) was deficient in
A. Didn’t cover Gelatin Preparation Steps, also 1ry & 2ry Actually it is A
packaging steps (Blistering & Cartooning), already ----------------- -----------
Which is a general observation in all implemented PV studies. planned to
include
gelatin
preparation,
primary
packaging
and
secondary
packaging
but it was
delayed due
to lack of

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. Equipment List wasn’t fully mentioned to include dispensing, Human It will be considered in the new Done
IPC & analytical equipment beside error due to version
production equipment to describe their statuses concerning deficiency of
(Qualification – Calibration – Preventive reviewing
Maintenance). guidelines
C. No CPPs specified with connection to corresponding CQAs. To be clarified in the PV Done
protocol
D. Processing steps should be detailed to indicate the processing Processing steps are already
parameters for each stage. included with details in the PV ---------
protocol for each product.
E. Associated documents should be fully detailed (Documents All associated documents will Q1/2023
needed to initiate the protocol & relative be referred to in the PV
SOPs at Production, QC, Utilities & Stability) protocol.
F. No mentioning for packaging materials formula. Human To be considered in the new Done
error due to protocol
deficiency of
reviewing
guidelines
G. No objective no scope for the protocol, also no version control Objective, Scope and version Done
section. control will be considered in
the new SOP
H. No stability section included to indicate type of stability To be considered in the new Done
required beside the involved batch number. protocol

The steps that
Assessment by
Timeline
inspector
annexes) taken
I. Process flow chart didn’t clarify the specified intervals for Intervals are in sampling plan Done
sampling. in the protocol
J. Not all products’ processes are validated. That’s normal as there's a large -------
number of products and it
increases as the customer
demand increase, and all
products are planned to be
validated.
K. PV reports don’t have a (Deviations/Variations) section to To be considered in the new Done
justify any deviations from the protocol protocol
occurred during implementing the study.
Cleaning Validation SOP was deficient in Human A Revalidation and verification Done
A. No cleaning revalidation or verification on specified intervals. error due to time intervals will be
B. Toxicity is not included in Products’ Matrix nor MACO deficiency of considered in the new SOP
calculations. reviewing B
C. Qualitative assessment for worst case products which is guidelines To be considered in the SOP
inaccurate & may be biased. C
D. No distinctive coding system for CV protocols & reports. Worst case product was
2.8. selected according to
formulation risk , lowest
therapeutic dose , solubility and
the toxicity (LD50) to be
considered in the new study.
D
To be considered in the SOP

The steps that
Assessment by
Timeline
inspector
annexes) taken
Equipment performance qualification Due to Hiring new employees Dec 2022
2.9. No PQ is implemented for any equipment. shortage in On going (plan issued )
manpower
Compressed Air Qualification was deficient in Human Updating layout to include Done
A. No layout for compressed air use points classified into error due to compressed air use points
(Product Contact – No Product Contact – Pneumatic). deficiency of
reviewing
guidelines
B. No schematic diagram for compressed air station. Human Issuing schematic diagram for Done
error due to air station
deficiency of
reviewing
2.10. guidelines
C. No microbiological testing for compressed air use points. Due to Waiting for micro lab up-grade Q2/2023
shortage in
manpower
D. No SOP for requalification intervals for all utilities & Human New Sop will be issued for for Done
equipment. error due to requalification intervals for all
deficiency of utilities & equipment.
reviewing
guidelines

The steps that
Assessment by
Timeline
inspector
annexes) taken
Thermal Mapping Studies were deficient in deficiency A. QA approval will be A.Done
A. No approval from WH & QA. of reviewing considered
B. Implementation should be each 3 years at Summer & Winter. thermal
C. Racks dimensions, Location numbers & Potential risk mapping B. adding to plan to be done
2.14. locations weren’t mentioned. study every 3 years B . Done
D. Worst case selection criteria after the study should include
minimum & maximum of actual results & minimum and C.D. considered C Done
maximum mean values.
E. Reference calibration certificates & Third-party accreditation
for calibration should be attached.
HVAC Qualification was deficient in Human A . will be considered A .Q2-
A. No viable count study. error due to 2023
B. No recovery & visualization studies at Class D. deficiency of B .recovery and visualization
C. No justification for chosen locations of Particulate count test. reviewing will be considered B .Done
guidelines
C .already there is a study for C .Done
chosen count test location
2.15.
3. Other
3.3. Bulk Holding Time (Protocol & Report):

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. No detailed procedure for selecting the worst case materials. Human error Updating SOP to include Done
due to selecting the worst case
deficiency of materials.
reviewing
guidelines
B. Didn’t consider the physical, chemical & microbiological physical, chemical and Done
concerns on the products themselves, Instead the study was microbiological concerns was
concerned with the individual materials only. considered as follows:
-raw materials were tested at
zero time (after dispensing )and
after 7 days
-ready prepared medicine tanks
were sampled and tested
(Micro and chemical)at zero
time and after 7 days
-Bulk capsules were tested
starting from the drying stage
till the primary packaging
within 45 days
-blisters were tested at zero
time and after 36 days (Micro
and chemical)

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. No evaluation for the chosen criteria described to assess the Human each raw material was assessed Dec-2022
materials. error due to based on light sensitivity,
deficiency of chemical stability and
reviewing microbiologically vulnerable
guidelines and to be explained in SOP
D. No distinctive coding system for HT studies. Human to be considered in the SOP 12-2022
error due to Waiting for new DC system
E. No version control for HT protocols & reports. deficiency of completed
knowledge
of GDP Version is already exist in Done
protocol and report
F. No Variations/Deviations section in the report to record There was no deviations and to -----
deviated items like the missed interval at blistering stage. be considered in further reports
Process Qualification Human error Actually revision is done with Done

No involvement for Validation Section in the review of due to QA approval
Qualification files of (HVAC – Compressed Air – deficiency of
Thermal Mapping – IQ/OQ equipment – Autoclave/Ovens – reviewing
Thermal Mapping). guidelines
3.10.
4. Comments

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. Laboratories
1. Critical
2. Major
2.1. Control of Documentation & records were deficient in that
Chemical laboratories Human error A.SOP will be issued to Q1/2022
A. The laboratory does not establish and maintain procedures to due to include:
control and review all documents (both internally generated and deficiency of control and review all
from external sources). knowledge documents
Management of SOPs inside labs does not exist. [QC & R&D] of GDP
B. There is no master list to identify the current version status, Master list will be issued Dec-2022
distribution & review dates of established documents. [QC & toidentify version status
R&D] distribution & review dates of
established documents
C. No SOP for coding instruments including identification labels SOP updated include the Dec-2022
(under issuing) [R&D]. identification labels forms
Under issuance code VSOP-00-
002
D. Either no labels or missed data (only “Buffer” with no more A new SOP for the laboratory Dec-2022
details) on HPLC bottles and no label for pH electrode Chemical preparations in
2.1.1 preservation buffer [R&D]. preparation.

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. No labels or logbook for HPLC columns (labels only on the Human error A new SOP for HPLC column Done
boxes not on the column itself with mix-up risk) [R&D]. due to qualification in preparation
deficiency of includes log book forms and
knowledge identification labels.
of GDP
F. Methods used are drafts (Royal vit G – Royal Jelly analysis) or Approved method will be Q1/2023
expired (L-SOP- 02-01 for Iron analysis in Royal vit G. issued for Royal vit G – Royal
Jelly analysis
G. Specifications of RM are not issued via R&D department, but Man error Specification of RM is quality Dec-2022
instead it is issued from RM department that may cause due to issue, R&D will review the
formulation problems as they are not studied by R&D. deficiency of final specification and give the
reviewing approval after the agreement
guidelines with QA and QC to the added
new system.

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. No controlled issuance of bound & paginated notebooks Human error Already all R&D logbooks are Done
[Control of Records] example: Working standards notebooks, due to controlled by sops:
analysts notebooks & Instrument logbooks. [QC & R&D] deficiency of
knowledge Logbooks according to sops:
of GDP - Instrumental logbook
(QSOP-01-006-22) (attachment
no. 2)
- Lab. note book (LOP-

04-001-03) (attachment no. 1)
- Stability Cabinet Log
book (QSOP-01-006-29)
(attachment no. 3)
I. There was no secured & controlled archives to archive records The place is The stability records and files Done
[R&D] small to are transferred to the lab to be
separate area stored in closed and secured
for archiving files’ cupboard.
J. Some data & records exist in the cleaning room (inappropriate Human error Record saved away from Done
protection from deterioration). due to cleaning room
Example: several documents signed/approved by QC manager in deficiency of
cleaning room subject to water &loss. [QC] knowledge
of GDP

The steps that
Assessment by
Timeline
inspector
annexes) taken
K. GDP Errors like overwriting, no dated signature, etc., Human error K Training is held GDP Done
 By reviewing Ca D-Panthonate notebook No label due to
identification for notebooks & the identification sheet of the first deficiency of
page the following data was not recorded: notebook No., the knowledge
previous notebook with several GDocP Errors. of GDP
 Repeated overwriting QSOP-01-006-03 On 1/9/2021 page 13
and 19/9/2021 page 14.
 Records and most of the forms’ content were not legible for
example Form: QSOP-01-006-32
‫ & ] ]متابعة نظافة معامل الرقابة‬LSOP-00-018-01. not reviewed nor
signed. [QC]
 Gap recording: INIP 49: Disintegration logbook there was no
recording from 27/1/2022 To 17/2/2022.
 Logbook no. of the analyst was written wrongly in the COA as
22009/83, while after revising the raw data from logbooks it was
found to be 22008/83 (typing mistake).
 Most of the logbooks were not identified.
 Change request of the VSOP-03-001 FP stability SOP indicates
changed procedures and forms while the amendment table states
“Addition of new procedures and forms” without any other
details [R&D].
 Lists of stability studies were related to obsolete versions of . Adding ID labels Done
SOP [R&D].
 VSOP-03-002 Stability Department on job training SOP
[effective date 22/04/2021] while Dr. Mohamed Etman’s training
on 03/01/2022 did not include t-test or F-test as in the SOP . Updating SOP vsop-03-001 12/2022
[R&D].
 Some dates in the training forms of Dr. Mohamed Etman were . Stability of finished
not written [R&D]. pharmaceutical product SOP
no. .(VSOP-03-001) will be
updated.

The steps that
Assessment by
Timeline
inspector
annexes) taken
L. QC method of analysis SOPs were, for most, not controlled by Human error Reviewing all analysis SOPs to Done
R&D nor QA ex: SOP- MH-02-048 due to be send to QA
deficiency of
knowledge
of GDP
M. COA issuing was not well controlled nor secured, making it Human error Updating SOP to be more 12/2022
easy that many versions can be issued for the COA without due to controlled
control or justification. deficiency of
N. Retention time of COA should depend on the presence of knowledge
stock of the PM. of GDP
O. Not enough identifications on encapsulation machines (No

batch no., starting date & time, signature)
P. Tests were recorded in SOP (LSOP-02-005) but not actually Human error Updating LSOP-02-005 to 12/2022
tested in the certificate of analysis (size and shape). due to remove (Size and shape) from
deficiency of it
reviewing
LSOP-02-
005 and
Q. The (clean) label or (to be cleaned) did not contain the compare it Updating SOP LSOP-00-28
Human error 12/2022
sampling equipment / tool name due to cleaning of equipment to
deficiency of change label to include
knowledge sampling / tool name
of GDP &
R. All cupboards and boxes in the physical lab were not GMP Adding a identification label to 12-2022
identified. all cupboards

The steps that
Assessment by
Timeline
inspector
annexes) taken
S. Daily rooms cleaning form for labs was not filled to the final Human error Monitoring of the form will be Done
date, then someone completed the data retrospectively. due to done by supervisor
deficiency of
knowledge
T. There was no identification for water vessels in the physical of GDP Adding identification label for Done
lab. water vessels in the physical
lab.
U. Sample size is different from the currently used form named SOP of analysis will be 12-2022
"Quantity of capsules required for analysis”, this form must be a changed to control this issue
controlled form and distributed to the concerned departments (FP
lab and IPC lab) via QA, the lab practice is applying a changeable
form done and checked by the FP lab staff without control or
distribution policy to IPC.

The steps that
Assessment by
Timeline
inspector
annexes) taken
Microbiology Laboratory Human error A Updating SOP Done
A. Expired SOP No.: LOP-03-001 for standard safety practice in due to
microbiology lab revision No. 02 with revision date: 01/11/2021 deficiency of LOP-03-001
present in the micro lab knowledge
B. No SOP for handling items when the temperature is out of of GDP B updating SOP
range and No risk assessment.
C. Generally most of microbiology logbooks were used for more C Done B 12/2022
than one year It is recommended to let the used logbooks for each
separate year D Work request was done to
D. Equipment’s documents need good documentation practice engineering in 16/5/22 to
where (Bad storage, overwriting, signature missed and placing on install racks on the wall Done
unrelated devices)
e.g., For decontamination autoclave in dates 22 / 02 / 2013 & E This will be considered in
24/01/2013 new SOPs
E. In the amendment table for any SOP, for the new revision
should mention the reason for creation not with the previous F updating micro lab layout
version.
F. The microbiology lab layout is not approved by QA and G Issuing new SOP for
Handwashing and rubbing 12/2022
without signatures and Code and version No.
2.1.2 Technique
G. No SOP for Handwashing & Rubbing Technique
H. The non-validated sodium hypochlorite 1% is used during
spillage I SOP will be updated
12/2022
I. The Microbiological Spillage needs more clarification and to
cover the spillage in LAF, in micro lab and outside micro lab how
to deal.

The steps that
Assessment by
Timeline
inspector
annexes) taken
2.20. Data Review & Approval was deficient in that
A. There is no documented procedure for routine & periodic Human error . Done
reviews as well as the approval of data. Examples: due to
 Lack of Supervision check and review in analyst notebook # deficiency of
22009 in Finished Products was not checked nor reviewed by knowledge
supervisor since 10 February 2022. of GDP and
 LSOP-02-005 Clause no. (7.2 & 7.4) The SOP needs to be reviewing
rechecked according to international guidelines. guidelines . Updating SOP LSOP-02-005 Dec 2022
 Incoherence in L-SOP 0025 was detected: 2 different durations
of analyst notebook retention are marked 6 and 3 years. (QC)
B. Physical tests results were recorded in the certificates without
any evidence of performance in the labs by the analysts. [QC] B an evidence will be attached
C. No check from supervisor was done for logbooks or the to physical test result certificate
calculations performed by the analyst leading Dec 2022
to the risk of releasing a product batch wrongly due to incorrect
calculations. [QC]
C. Done
2.21. Calibration, verification of performance and qualification of equipment, instruments & other devices were deficient in that :
Chemical laboratory Human error Contacting with ENG Q1/2023
A. Some equipment were not calibrated such as hood, due to department to add those
Microscope, Pycnometer & hardness (No SOP, deficiency of equipment to calibration plan
certificates nor records). knowledge
of GDP and
reviewing
guidelines

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. UPLC qualification due date is 02/03/2022 (Waters Human The qualification SOP is Dec 2022
manufacturer states that it may be extended to 15 error due to initiated according to the
months but no SOP mentioning this) [R&D]. deficiency of manufacturer guideline
knowledge (Waters) and include the
of GDP and requalification period (12-15
reviewing months)
guidelines
C. No SOP for HPLC column qualification [R&D]. Human A new SOP for HPLC column Dec 2022
error due to qualification in preparation
deficiency of includes log book forms and
knowledge identification labels
D. Balances calibration in R&D: Human - Updating SOP of each Done
 No calibration of balances with certified weights except error due to balance: radwag SOP no.
annually by an external service provider. deficiency of (VSOP-00-001)
 Also, internal checks of balance in the SOP did not mention the reviewing
frequency of internal checks. balances – Sartorius SOP no. (VSOP-02-
 No calibration sheets for balances. calibration 001)
 Balance no. RDM-05-1 has 2 external calibration labels one for
2021 with unidentified (unreadable) month and the other with – kern Sop no. (VSOP-01-001)
JUN-2022 and due date is JUN-2023.
- A new SOP is initiated
for balances qualification under
issuance (attachment no. 7+8).
- Typing mistake from the
external service provider where
the calibration certificate is
correct Jan 2022.
- The label is corrected.

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. pH meter calibration in R&D: Human  The SOP for the pH meter . Done
 No calibration sheet of pH meter. error due to no. (VSOP-02-003) is updated
 Although there is an activity of calibration indicated in the pH deficiency of and includes the needed sheets . VSOP -
meter logbook, no calibration is reviewing  The New version of the 02-003
stated. balances SOP include calibration sheet. updated to
 Calibration section of the pH meter refers to an Appendix calibration VSOP-00-
which is photocopy of the manual with 002
unclear figures, unexplained abbreviations, and 2 methods with
no indication to follow which of
them.
F. Some equipment is not correctly calibrated to cover operation Human A new service request is done
range. example: error due to for performing calibration with
 Analytical balance (testing weights) 0.02g to 220 g. While deficiency of the correct range & dissolution
actually, it weights from 12 mg. reviewing qualification is performed
 Manipulation in external calibration certificate of balances
disintegration Certificate No. (A04-R024-2021) manual
as it calibrated the no. of strokes per min. for (50, 100 & 150);
While the instrument is restricted for 30 stroke/min, The USP
limit is (29-32)
 Timer calibration range while the working range extends to 2
hours.
 Dissolution device is only calibrated and not qualified
according to USP chapter.
G. Form no. QSOP-01-006-25 the calibration acceptance weight Updating form to be 12/2022
limit is +/-0.003 g; While SOP the compatible with SOP
calibration acceptance weight limit is +/- 0.0003 g

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. Use of inadequate instruments such as old calibers and Human PO request sent to purchasing Q2-2022
micrometer error due to department for new instruments
deficiency of
knowledge Waiting for budget approval
I. Caliber INM01 is not calibrated, its calibration Due Date was 9 According Done
March 2022. to calibration
plan it will
be calibrated
07/2022
J. No working instructions for caliber and micrometer. Human Work instruction will be issued Done
error due to
deficiency of
knowledge
of GDP
K. The hood is not calibrated, that may cause inefficient suction Due to calibration plan it will Dec-2022
of fumes of chemicals and reagents. be calibrate in 12/2022
L. Analytical top balance (4 digits) is used for quantitative Human error A purchasing request sent to Q1/2023
analysis, The test weights are under the due to purchasing department for a 5-
balance minimum weight (repeatability) 12 mg. deficiency of digits balance is made
M. the 5- digit balances are used for less than 80 mg which is not reviewing
correct according to USP General chapter 41 for balances. guidelines
N. The minimum weight is calculated in an inappropriate way
(INIPC-02).
O. No spare Part for packaging INM01 A purchasing request sent for Q2/2023
availability of spare parts
P. Calibration of balance is not including the actual values of Human error a service request is sent for 12/2022
reference masses (calibration certificates due to making calibration with the
corrections). deficiency of correct range
reviewing
guidelines

The steps that
Assessment by
Timeline
inspector
annexes) taken
Q. The microscope (INIPC-01) is not calibrated nor the reference Human Email sent to engineering 12/2022
slide. error due to department for INIPC-01
deficiency of calibration
reviewing
R. There is no instrument list, nor sampling equipment’s (tools) Human Instrument list and sampling 12/2022
list which are not coded as well. error due to equipment will be issued
deficiency of
knowledge
of GDP
S. Wrong label on logbooks INFP 42 while the instrument is INIP Human error Adding new calibration label 12/2022
42 & there is no labels for internal calibrations. due to with wright data
deficiency of
knowledge of
GDP and
reviewing
T. Malfunctioned or out of use instruments are sent for Human A risk assessment will be done -----------
maintenance but no evidence of announcing to error due to in case of changing instrument
QA by deviation, but instead the lab undergo analysis via any deficiency of that used for analysis
other instrument as an internal solution knowledge
without studying the risk of using this instrument or ensuring the
of GDP and
qualification, like to like and/or training of this instrument.
reviewing
guidelines
Microbiology Laboratory Human LAF is done But Q4 2023
A. Some used equipment (e.g., decontamination autoclave, LAF, error due to decontamination autoclave was
….) is out of calibration, validation and deficiency of failed in calibration, we need to
need maintenance and still under use. knowledge upgrade the micro lab.& to
of GMP obtain new autoclave for
media preparation and the
existing autoclaves will be used
for decontamination

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. The decontamination autoclave: Human Label will be signed and all Done
Have label for the intermediate check without signatures and error due to label will be reviewed
without meaning because the maximum deficiency of
thermocouple is under calibration from 3 months ago reviewing
guidelines &
C. Tissues exist under decontamination autoclave (Tau sterile GDP Work request sent to Q4/2023
autoclave, INMB04) which need maintenance engineering in 16/05/22 to
repair the autoclave but waiting
for budget approval
D. Normal refrigerator with freezer code INMB09 was used for A new purchasing request will Q4/2023
storage of prepared media, which is non GMP, scientific be issued for new refrigerator
refrigerator should be used. with specific criteria
E. The freezer in refrigerator INMB09 is not calibrated and Done

without temperature monitoring where it is used for microbial but COA of calibration will be Dec 2022
culture storage. sent
F. The alarm setting for Memmert incubator with code No.: Updating the alarm setting to Done
INMB14 is 50 oC while the temperature range is 20-25 oC be in range
G. No temperature monitoring in some days without justification. Daily report will be reviewed Done
e.g., Form LSOP-00-016-06 temperature monitoring for incubator by supervisor
INMB02.
H. Pressure gage between changing room (classified) and A work request sent to 12/2022
preparation room (unclassified) is not working engineering
and out of calibration To fix it and calibrate it

The steps that
Assessment by
Timeline
inspector
annexes) taken
I. The balance in media preparation room was not connected with Human A request sent to IT to connect Q1/2022
printer. error due to a printer with balance
deficiency of
data integrity
practices
J. Old & unqualified LAF exist in testing room with uncleaned Human error The existing LAF will be Q4 2023
balance. due to replaced with a new one after
deficiency of lab upgrading
reviewing
Analytical Method Validation guidelines
Chemical laboratory Human  The SOP of the 12/2022

A. SOP Code: VSOP-02-007 (Validation of analytical methods) error due to analytical method validation
was deficient in the following: deficiency of no. (VSOP-02-007) in
 The SOP is focused on HPLC methods only by using peak area reviewing preparation.
instead of response and robustness parameters and system guidelines
suitability parameters are related to HPLC. The update will cover all the
 Raw data are not mentioned in the report (Accuracy: points and correction of the
concentration, linearity: average peak typing mistakes.
area) refer to chromatogram.
 Equations of standard deviation (SD) pooled SD and relative
standard deviation (RSD) and -
pooled RSD are not indicated.

The steps that
Assessment by
Timeline
inspector
annexes) taken
 One-way ANOVA test using Minitab for accuracy are Human error - One-way ANOVA test will be Dec./2022
mentioned without any details to perform it on Minitab software due to deleted while it is not suitable
and not mentioned in the method validation report. Also, deficiency of for the testing the accuracy
statistical table for F-value is mentioned as “Table A.3” but not reviewing results.
included in the SOP. guidelines
 Resolution limit is not expressed as percentage while in SOP it -value will be deleted from the
is mentioned that “R ≥ 1.5%”. report.
 Limit of N is ≥ 1000 while FDA states that the
recommendation is not less than 2000.
 K’ is not mentioned as a system suitability parameter.
 Intercept is not indicated in the assessment of linearity.
 Conditions of specificity is fixed, it should be modified to
attain adequate degradation.
 UV-light in specificity: wavelength is not indicated.
 The accuracy section for impurities there was discrepancy in Human All this items will be Q1/2023
number of samples prepared for error due to considered in the New SOP
accuracy determination, and the acceptance criteria contain more deficiency of
than one limit without any reviewing
explanation to use which of them. guidelines
 Some typing mistakes e.g., using “Mobile phase variation”
instead of “Flow rate variation”
and “Mg/cap” instead of “mg/cap”.
 The method transfer SOP should be updated and forms should
be added to describe the
responsibilities of R&D and QC directorates.
B. Compendial methods used for raw material analysis are not Human error New SOP will be issued for Q1/2023
verified. due to verification of Compendial
deficiency of methods
reviewingguid

The steps that
Assessment by
Timeline
inspector
annexes) taken
In Microbiology Laboratory Human A . A purchasing request will A
A. No monitoring for compressed gas system error due to be done Q3/2023
B. In air monitoring only Bacterial count is monitored deficiency of B . Validation for the
C. No risk assessment for environmental sampling points. reviewing incubation temperature & time B Done
D. Non-viable particulate matter Is annual monitoring guidelines for monitoring air is under test
E. Purity test was not performed for standard microbial culture C .
during maintenance. The assessment will be started
after the validation in point C Q2/2023
2.5.2.B
D.
This was done by green tk
E.
A mail will be done to Pharco
B to help us for using BBL
instrument (microbes
2.4.2 identification) E 12/2022
2.5 Premises were deficient in that

2.5.1 Chemical laboratory Human Q2/2023 ------
A. No air conditioning (supply or return in washing room) that error due to air conditioning (supply and
can cause hazardous effects on personnel working there. [QC & deficiency of return in washing room) will be
R&D] reviewing studied by Engineering
guidelines department

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. No data loggers in the lab or refrigerator for following-up the Human -Data logger purchase request Q1/2023
temperature [R&D]. error due to is performed on 01/12/2021
deficiency of with PO no.: cp_1359/21 to
reviewing temperature monitoring
guidelines
C. No control for environmental conditions in RM lab, although Work order sent to engineering
the monitoring is done efficiently, but the monitoring is done department for adding more
using only one data logger, causing the risk of malfunctioning data loggers
and no registering, or following up of temperature and humidity
D. No stability samples reconciliation [R&D]. -Stability of finished

pharmaceutical product SOP
will be updated including
stability samples reconciliation.
E. Humidity/temperature reading are out of limits in monitoring Human Work order sent to engineering 12/2022
labs. error due do department to review
deficiency of environmental condition
following up
2.5.2. Microbiology Laboratory Human error Will be considered during lab Budget
A. Microbiology lab design need upgrading as following due to upgrade approval
deficiencies were found: deficiency of
 No material receiving area reviewing
 No entry changing room guidelines
 No microbial culture room
 No decontamination room
 Area of rooms was not sufficient to the microbiology activities
 Microbial culture room was non classified

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. Pass box should appear in the lab layout Human This observation will be Q4/2023
error due to considered during lab
deficiency of upgrading by Engineering
reviewing department
C. Dynamic pass box should be used between the classified and guidelines
unclassified rooms where the existing and
pass box between the testing room (classified) and preparation knowledge
room (unclassified) is static. of GEP
requirements
D. Culture maintenance was done at instrumental room Q4/2023
(unclassified) without a flame or Biosafety
cabinet and without sufficient area for work.
E. The air supply and return in the lab. were not identified. Identification label will be Done
attached for return and supply
units
F. Instrumental room, one cupboard used for coats: Human Identification label will be Done
 Part used for collecting clean coats without identification label. error due to attached to collecting clean
 Tween cartoons stored in the cupboard where they should not deficiency of coats
be stored, Cartons should be prevented in the micro lab. reviewing
guidelines
No area for
storage
G. Air handling unit is not worked in microbiology lab Human Work order sent to engineering Q4/2023
error due to department for maintenance
deficiency of
reviewing
maintenance
H. Rust exists in micro lab. Human Work order sent to engineering Q1/2023
error due to department
deficiency of
reviewing

The steps that
Assessment by
Timeline
inspector
annexes) taken
I. Presence of leather chairs in microbiology rooms (Specially Human error Purchasing request sent to Q1/2023
with microbial culture maintenance) due to purchasing department for
deficiency of changing leather chairs to be
reviewing ST.ST
guidelines
J. Some equipment exists in the micro lab. under maintenance for Human Work order sent to engineering Q1/2023
a long time. It should be removed from the micro lab. error due to department
deficiency of
reviewing
maintenance
K. No step over bench in changing room Deficiency Step over bench will be Q4/2023
in GMP installed during lab upgrading
knowledge
L. The corridor before entering the lab is dirty Due to A work request sent to services Done
absence of department for cleaning daily
daily with following UP
M. The floor and corners and air grills need cleaning. cleaning and
N. In the washing room and under the sink, dirt exists deficiency in
applying
2.6 Contracts were deficient in that
2.6.1 A. There is no quality agreement between Safe Pharma and Q1/2023
SEDICO for Skip testing for the analytical
B. The stability lab was not assessing the competence of a
contracted lab. [R&D]
C. No Audit on the supplier of PM. Human An external audit plan issued Done
error due to including PM suppliers
shortage in
manpower

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. Very weak following up practices for QA & QC inspectors Human Hiring new employees for new Done
during blistering and cartooning; Whereas the operators bypass error due to tasks
the sensors action. shortage in
2.7 Cleaning and cleaning validation systems were deficient in that manpower
2.7.1. A. There is no Cleaning Validation System: (SOPs, Protocols, Cleaning Validation will Dec 2022
Sampling plan for equipment); Only visual check from QA and consider this issue
random microbiological samples; No evaluation from the
previous product (chemical, detergent evaluation) Not even non-
specific tests (pH, EC, or TOC).
B. Validation of cleaning of sampling tools was revised, the Human Reviewing acceptance criteria Q2/2023
acceptance criteria was wrongly written as error due to for TOC and risk assessment
(TOC must be less than 500 ppm) while it should be less than 500 deficiency of will be considered the effect of
ppb, the results of the study show results more than 1 ppm which reviewing using sampling tools
is higher than the correct acceptance criteria, which invalidate the guidelines
validation of the cleaning procedure of sampling tools. A risk
assessment must also be done to study the effect of using these
tools in sampling procedure with improper validation study of its
cleaning.
2.8 Reference substances & reference materials were deficient in that
A. No intermediate check is done for the working standard to Human Issuing a procedure for Dec 2022
ensure its validity during the one-year expiry period given. error due to reviewing validity of working
deficiency of standard
2.8.1.
following up
B. Reference standards purchased and received by the Human Issuing a form for receiving Dec 2022
documentation section are delivered to the lab error due to and delivering standards
with no evidence, no receipt record is present for such activity. deficiency of
knowledge

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Waste management and reconciliation of remaining working of GDP Issuing a new SOP for Waste Dec 2022
standard quantities practice is not present. management and reconciliation
of remaining working standard
D. Expired reference standards of gabapentin (Batch number Human
I0K190: 31/10/2016, Batch number error due to
R020J0: 31/05/2019) [R&D]. deficiency of
reviewing
2.9 Specifications were deficient in that
A. There are no controlled documents specifications for Human New SOP will be issued Dec 2022
intermediate or finished products. error due to
deficiency of
knowledge
B. No controlled sampling plan including acceptance criteria Human error A sampling plan will be issued Q1
due to to include acceptance criteria
deficiency of
reviewing
guidelines
C. Discrepancies between COA specs and NODCAR
2.9.1 Comparison URINEX Comparison URINEX Comparison URINEX
COA NODCAR COA NODCAR COA NODCAR
Average weight of Average weight of Average weight of
capsules 180.09 ±10 % capsules 180.09 ±10 % capsules 180.09 ±10 %
175 ± 10 % 175 ± 10 % 175 ± 10 %
Average weight of Average weight of Average weight of
content 100 ± 10 % content 100 ± 10 % content 100 ± 10 %
100 ± 6 % 100 ± 6 % 100 ± 6 %
Density 0.89- 0.93 Density 0.89- 0.93 Density 0.89- 0.93
------- ------- -------

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. Specifications of RM are not issued via R&D department, but R&D R&D will assigned to issue Q1/2023
instead it is issued from RM department that may cause consider as a specifications of RM
formulation problems as they are not studied by R&D. new
department
2.10 Personal hygiene was deficient in that
A. Medicine preparation operator is not committed to hygiene Human A . an action taken with
rules (long dirty nails). (3.1) & (11.5) error due to Mohamed Islam Wageh
B. Operators on encapsulation don’t wear gloves. Lack of
C. The way of checking the medicine tank label is potential for GMP B . Done
malpractice hygiene from production training for
operators operator C . Done
2.10.1
2.11 Retained Samples were deficient in that

A. No Sampling Room, no retained samples store for packaging Sampling Room: waiting for Q4/2024
materials Unavailabilit warehouse department reply on
y of area is using raw material sampling
consider a room (short term solution), a
main reason new sampling room will be
built (long term solution)
B. Storage areas are not maintained within acceptable and Human Daily check will be consider 12/2022
specified temperature limits. error due to
deficiency of
following up

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. According to thermal mapping of Refrigerator INRM 026 There was Replace current data logger to Budget
requires 2 positions for temp monitoring but only one data logger only one be installed in right position approval
INRM33 was placed in the wrong position data logger Waiting for availability of more
available at data loggers
that time
(there is no
D. LSOP-02-033 is updated containing forms which is not Human The form is applied Done
applied since its issuance. Ex, LSOP-02-033- 07 bottle label. error due to
lack of
E. No sample management, no bin location, no labels & no following
Human the layout of the retain sample 12/2022
Layout in retain samples room. error due to room will be done & SOP will
following up be updated
F. The quantity of retained samples is not included in any SOP. Human The quantity will be mentioned 12/2022
error due to in SOP
lack of
following
GDP
2.12 Microbiology lab. were deficient in that

In Investigation Out of Specification results in microbiology lab Code: LSOP-03-004 V: 03
A. The isolate is not identified. Human A mail will be done to Pharco Q1/2023
error due to B to help us for using BBL
deficiency of instrument (for isolate
2.12.1
knowledge identification)
of GMP
2.12.2 In SOP: Gowning at microbiology lab SOP No.: LSOP-03-059

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. The use of access control is not mentioned in the SOP. Human Updating of LSOP-03-059 to Q1/2023
error due to include the access control
deficiency of
reviewing
guidelines
B. The white coat used in all unclassified areas (inside and Human A specific gowning (different Q1/2023
outside micro lab) used for culture maintenance which leads to error due to suit ) will be available for
cross contamination. deficiency of classified area and unclassified
knowledge area
of GMP
2.12.3 SOP Name: Microbiological Test for Water SOP No.:LSOP-03-021 Version No.: 05
A. The existing layout of water treatment plant and purified water Human error Layout will be update Done
in microbiology lab is not updated Purposes du to
Drawing Code: LO-009, Version No.: 03, Revision Date: 1-3- deficiency of
2019.. following up
B. The flushing time and flow velocity in the SOP is not correct Human error SOP will be updated to Q1/2023
as mentioned in the updated USP. du to include :
C. No verification or sampling procedures study deficiency of The flushing time and flow
reviewing velocity
guidelines Verification and sampling
study
D. No microbiological water analysis validation study for the A validation study for water Q4/2023
method used. analysis will be considered
A. The Pre-treatment water samples not mentioned how it will be Human error Updating SOP to include : Q1/2023
2.12.4 analyzed due to How to analysis The Pre-
deficiency of treatment water samples
B. The maximum hold time between sampling and analysis not reviewing Updating Sop to include Q1/2023
mentioned in the SOP. guidelines The maximum hold time
between sampling and analysis

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. For samples which contain chlorine the SOP did not mention Deficiency Updating SOP to include : Q1/2023
the suitable neutralizing agent to be used while in practice sodium in following the suitable neutralizing agent
thiosulphate is used with concentration 1% without validation. GDP to be used
instruction
D. No microbial identification for the isolates. A mail will be done to Pharco Q1/2023
B to help us for using BBL
instrument (for isolate
identification)
E. In clause 7.3, the specification (Action or Alert limit) was not Updating SOP to include : Q1/2023
identified when the result will be conform or not conform. -Alert limits
F. The number of sampling point in reality did not match that in - when the excursion should be
the SOP created when the result exceeds
G. The SOP did not mention when the excursion should be the alert limit.
created when the result exceeds the alert limit. - Water monitoring trend
H. Water monitoring trend not mentioned in SOP and not
applicable.
2.12.5 SOP Name: Preparation, Dispensing, Sterilization, Testing & Storage of Microbiological Media SOP No.:LSOP-03-034 Version No.: 04
A. No approved supplier list for dehydrated media and reagent. Due to -following supplier approval Q1/2023
The SOP did not mention how to evaluate the supplier shortage in SOP QSOP-04-016
manpower
B. Absence of physical inspection for dehydrated media Human error Updating of the LSOP-03-034 Q1/2023
containers before using in lab comparing with the Supplier due to to include:
specification. deficiency of -Stability study for the
C. Stability study for the dehydrated media container after reviewing dehydrated media will be
opening was not done. guidelines considered
D. The SOP did not mention where molten media (e.g., TSA after

The steps that
Assessment by
Timeline
inspector
annexes) taken
sterilization) are held or kept, and for -where molten media are held
how long they should be kept. or kept
During audit, one molten SDA bottle was kept in the incubator
(50-60OC) for more than 8 hours without
stability study.
A. No prepared media shelf period study. Less number Will be considered done Q3/2023
2.12.6 of
microbiologi
B. The SOP did not mention when prepared media should be Human error Updating of the LSOP-03-034 Q1/2023
discarded? due to To include :
deficiency of when prepared media should be
reviewing discarded
C. The prepared media was stored over the equipment e.g., guidelines
Due to Will be considered during lab Q4/2023
incubators, autoclaves in unclassified areas unavailabilit upgrade
with un working HVAC system, and some media was stored y area for
beside the area used for culture renewal. storage
The stored prepared media in the refrigerator were not arranged
well in a way to prevent cross contamination.
D. Training on Media preparation was just by reading the SOP. A challenge will be considered Q1/2023
(No practical evaluation.) or exam will be done
E. No evaluation study of inhibitory effect of detergents residues Human error A study of inhibitory effect of Q2/2022
on cleaned glassware due to detergents residues on cleaned
deficiency of glassware will be considered
reviewing

The steps that
Assessment by
Timeline
inspector
annexes) taken
F. In form No. QSOP-01-006-05 with title media preparation guidelines Updating Sop QSOP-01-006- Q1/2023
logbook, it shows that only one pH value is 05
recorded where it should be with 2 values one before sterilization
and other after sterilization.
The SOP did not mention how to adjust the pH value of prepared
media, also it didn’t mention how to
measure the pH value of agar media and broth media.
2.12.7 In SOP Name: Growth Promotion test of media SOP No.: LSOP-03-061 Version No.: 02
A. Isolates used in the test were not identified. Human error A mail will be done to Pharco Q1/2023
due to B to help us for using BBL
deficiency of instrument (for isolate
reviewing identification)
guidelines
B. In form No. LSOP-03-061-01, the form does not include data Human Updating of the LSOP-03-061 Q1/2022
about the failed media (e.g., Media error due to
Name, Batch No., preparation date ….......) deficiency of
 The media preparation steps, the analyst who do the test are not knowledge
included in the investigation. of GMP
 Corrective action plan is not included in the form
 QA should be included in the investigation or even in the
repetition of the case or even as information.
 Investigation Serial No. should be created.
 List of test failure cases should be created.
C. The approval date of the SOP was 02/03/2022, The issuing Human GDP training will be done Done
date of the SOP is 01/03/2022, The effective date of the SOP was error due to
01/04/2022 while the SOP was applied in March before the lack of sop
effective date of the SOP revision

The steps that
Assessment by
Timeline
inspector
annexes) taken
3. Other
Laboratory Safety was deficient in that : Human error Eye washer will be installed Done
due to lack
3.1. A. Safety instructions were not followed as no mask was worn of
while using Petroleum ether. knowledge
B. No safety tools like eye washer, Chemisorb, Safety shower of the
[R&D]. importance
3.2. Reagents were deficient in that of PPE
A. Reagent was not identified by hazard label. Human error Identification label will be add
due to lack
of revision
B. According to MSDS of Petroleum ether 60-80̊C Should be There is Monitoring temperature
stored in cool place while its current storage in room temp. already air
condition
and area is
controlled as
temperature
C. Naphthalene is stored in the refrigerator although it is not not
Lackexceed
of Naphthalene will be stored Done
3.2.1.
required as storage condition in the safety data sheet (SDS). revision of according to MSDS
SDS for
material
D. Some reagents are given 6-month expiry period without Human A study will be performed for Q1/2023
justification or studying the effect of changing suppliers or error due to reagents expiry , expiry
monitoring of the reagent during the expiry period, no visual deficiency of following up list will be issued
inspection is performed to ensure that the reagent is suitable for reviewing
use. guidelines
E. Testing solutions in IPC lab: there is no stability study for the
expiry recorded on the label.

The steps that
Assessment by
Timeline
inspector
annexes) taken
Microbiology Laboratory Human A . Done A Done
A. Alcohol bottle exists in washing room without identification of error due to
alcohol name. deficiency of
B. Sterility test by pour plate method should be done for all sterile knowledge
ready-made received lots for sterile of GMP B . Initiating a new SOP B Q1/2023
.2 items e.g., sterile water cup, sterile swab …...etc. requirements
Housekeeping was deficient in that Benches, surfaces, Due to Administration department
computers, keyboards, …etc. are not clean (Poor care & Poor shortage in was requested to clean area
cleaning) and practically no existence for the check. manpower in periodically
services
3.3. (administrati
on)
3.4. Microbiology SOPs were deficient in that
In Investigation Out of Specification results in microbiology lab Human error Updating of the LSOP-03-004 12/2022
Code: LSOP-03-004 V: 03 due to to include this following :
A. The investigation does not connect the failure of the product deficiency of -investigation shall connect
with the results of environmental monitoring and water. reviewing failure in environmental and
B. In clause 5.1 it doesn’t mention first that the analyst should guidelines water monitoring
follow the standard method procedures -analyst should inform his
and in case of any deviation he should inform his direct direct supervisor before starting
supervisor before starting any investigation any investigation
and he should share in the investigation not to perform it himself
as mentioned in the SOP

The steps that
Assessment by
Timeline
inspector
annexes) taken
In SOP: Gowning at microbiology lab SOP No.: LSOP-03-059 Human error Updating of the LSOP-03-059 12/2022
A. The cover head and beard cover should be used during media due to to include :
preparation deficiency of -when the used coats should be
B. The face mask & gloves are not used during the product knowledge send to the Laundry for
analysis or culture maintenance. of GMP washing.
C. The SOP did not mention when the used coats should be send requirements
to the Laundry for washing. and safety
precautions

The steps that
Assessment by
Timeline
inspector
annexes) taken
SOP Name: Microbiological Test for Water SOP No.:LSOP-03- Human error A . either spraying or
021 Version No.: 05 due to immersing with alcohol the
Pharmaceutical deficiency of alcohol will be evaporate
A. In clause 7.1.1, The disinfectant of the water sampling point is reviewing
not by spraying it should be by Purposes guidelines B . updating of the LSOP-03-
sanitizing the outer surface of the sampling point using a wipe 021
immersed with alcohol (70%).
B. In clause No. 7.1.3, it is mentioned that they used sterile C . updating of the LSOP-03-
sample bottles with volume 100 ml and the 021 B,C
sample quantity 100 ml while the sampling bottle size should be Q1/2023
more than the volume required to give chance for good shaking D . a work request sent to
before analysis for good homogeneity. Also in clause 7.1.4, the engineering in 16/05/22
part of do not leave an air space should be removed
C. The SOP did not mention how to prepare the sampling E . a work request was sent to
container. engineering in 16/05/22
D. The softener is not represented in the purified water treatment
plant layout F , G updating of the LSOP-
E. The 2 UV lamps are not numbered in the purified water 03-021
treatment plant layout. (UV lamp 101&102)
F. In the Water treatment plant layout legend SV symbol is used
for sampling valve where in the SOP
and real point SP symbol is used.
G. In clause No. 4.1: The reference is not updated, the chapter
name & No. is not mentioned for referred
pages.

The steps that
Assessment by
Timeline
inspector
annexes) taken
SOP Name: Preparation, Dispensing, Sterilization, Testing & Storage of Microbiological Media SOP No.:LSOP-03-034 Version No.: 04
A. Chemical & Dehydrated Media Certificate of Analysis and Human error A , B done
material safety data sheet not be placed beside media preparation due to
B. Personal protective equipment does not exist beside media deficiency of C, updating of the LSOP-03- C 12/2022
preparation knowledge 034
C. The check list of received media did not include the actual of GMP D 12/2022
received quantities of media . requirements D . updating of the LSOP-03-
D. For each received dehydrated media container, put a label of and safety 034
receiving mentioning the receiving date, container number, precautions
container opening date, used before (After opening) and container
opened by
(signature).
3.
44

The steps that
Assessment by
Timeline
inspector
annexes) taken
E. Some points need to be added to the procedure of storage of Human error E . updating of the LSOP-03- 12/2022
dehydrated media and reagent as: due to 034
 Store at designated area away from potential contamination. deficiency of
 Store safely, protected from humidity or moisture (dry area), reviewing F . updating of the LSOP-03-
light and heat (e.g., autoclaves, guidelines 034
drying ovens, or other heat sources), which are the most frequent
causes of their alteration. G . updating of the LSOP-03-
 Store continuous tightly sealed since dehydrated powders are 034
hygroscopic particularly containers
which are frequently opened and closed.
 Arrange the containers according to FEFO rule (First Expired
First Out).
F. In clause 7.4.3, The SOP mentioned that the only case of
discarding the dehydration media container is in case of expiry
date while there are other cases that should be included.
G. The SOP did not mention how to deal with glassware & tools
H. After check the physical appearance of media and close the
container tightly. should be mentioned and recorded in the SOP.
I. The SOP did not mention how to re-melt the agar media.
J. The SOP did not mention how the prepared media dispensing
in plates.
K. Some dehydrated media which still under evaluation before
receiving the whole containers, was kept
with opened used container and other with closed containers
without a special label to recognize that it is under evaluation.
The SOP did not mention how to recognize the status of the
media.
L. Existing form with name microbiology lab medium (No.2)
which is not part of the SOP and without
signatures.

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. After sterilization, check the physical appearance of media and Human error H . updating of the LSOP-03- 12/2022
close the container tightly. should be due to 034
mentioned and recorded in the SOP. deficiency of
I. The SOP did not mention how to re-melt the agar media. reviewing I . updating of the LSOP-03-
J. The SOP did not mention how the prepared media dispensing guidelines 034
in plates.
K. Some dehydrated media which still under evaluation before J . updating of the LSOP-03-
receiving the whole containers, was kept 034
with opened used container and other with closed containers
without a special label to recognize that it K . updating of the LSOP-03-
is under evaluation. 034
The SOP did not mention how to recognize the status of the
media. l. updating of the LSOP-03-034
L. Existing form with name microbiology lab medium (No.2)
which is not part of the SOP and without
signatures.
3. In SOP Name: Growth Promotion test of media SOP No.: LSOP-03-061 Version No.: 02
4. A. For Brilliant green agar & Burkholderia cepacia supplement Human error A . updating of the LSOP-03- 12/2022
agar, the indicative and inhibitory test should be involved. due to 061
B. In Clause 7.4.5, No reference or the previously tested media deficiency of
not exist to compare the plates. reviewing B . updating of the LSOP-03-
guidelines 061 12/2022

The steps that
Assessment by
Timeline
inspector
annexes) taken
4. Comments
Housekeeping was deficient in that R&D area Contacting with top Q2-2023
A. R&D balance room is not suitable for good weighing practice. need management about the need of
B. No defined area for R&D department while purchasing & toll extension as extension for R&D place
departments exists inside the boundaries of the lab. current place
C. The cleaning room is so small to perform the work. [R&D] is very small Waiting Budget approval
D. Sampling equipment’s cleaning methods, applications and
storage need improvement Human
E. There is no quarantine system error due to
F. There are no holding time studies for products between stages deficiency of
G. There are no holding time studies for equipment (cleaning reviewing
equipment holding time & Dirty equipment holding time) guidelines
H. The finished product boxes are not serialized or aggregated in
packaging area
I. No chemicals Cabinet or room in R&D labs.
4.1.
In SOP: Gowning at microbiology lab SOP No.: LSOP-03-059 Deficiency A . updating of the LSOP-03- 12/2022
A. The title should be entry, gowning, personal behavior and exit of GDP 059
from microbiology laboratory knowledge
B. The SOP should mention more details for each step in the lab B . updating of the LSOP-03-
with photos 059 12/2022
4.2.

The steps that
Assessment by
Timeline
inspector
annexes) taken
4.3. SOP Name: Microbiological Test for Water SOP No.:LSOP-03-021 Version No.: 05
A. Responsibilities need more details as follows: Addition by Update SOP to add more Jan 2023
 Q.C Water Sampler audit details
1- Prepare the sampling bottles and make the label for sampling 1-Q.C Water Sampler
bottles. Addition by
2- Follow the sampling schedule. audit 2-Monitoring Analyst
3- Apply the check list form for sampling points and writing the 3- Direct supervisor
reason of not taking the sample.
 Monitoring Analyst
1- Prepare the testing equipment and media, & perform growth
promotion on the used media.
2- Assure that testing equipment, utilises and media are sterile
and in proper condition during
testing and for readymade items which used it is not expired.
3- Follow the sampling schedule.
4- Assure that sampling techniques are applied properly.
5- Count & identify the microbial isolates.
6- Documents and report result.
7- Check the water sampler of following the sampling schedule.
 Direct supervisor
1- Check and interpret the results.
2- Determine and report the out of specification results (if any).
3- Summarizes the data.
4- Check the water analyst and water sampler to follow the SOP
procedure.
B. It is not mentioned in the SOP that the samples should be Deficiency Updating of the LSOP-03-21 to Dec 2022
collected from use points using the same of GMP include which samples should

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Water analysis logbook is not mentioned in the SOP knowledge be collected from use points
D. The characteristic of tested specific microorganisms (except E. using the same
coli) were not mentioned Analyst logbook
E. For purified water, the filtrate is 1 ml by pour plate method; it Deficiency Updating of the LSOP-03-21 Dec 2022
is preferable to filtrate 100 ml instead delivery device, such as of GDP
hoses while it is applied. knowledge
SOP Name: Preparation, Dispensing, Sterilization, Testing & Storage of Microbiological Media SOP No.:LSOP-03-034 Version No.: 04
A. The USP (Revision 41) is used as a reference which is not the Human error Updating SOP .:LSOP-03-034 Dec 2022
updated version due to to include :
B. In clause 5.2, adding (or designee) after microbiology lab. deficiency of - when the MSDS should be
Lead and adding (s) to procedure. revision ,add used
C. In Clause 6.1, the application of checklist does not show the ition by - a serial number for Each new
responsibility. auditor for received dehydrated media
D. The SOP did not mention when the MSDS should be used improvemen container
E. Each new received dehydrated media container did not have t -adding responsibilities in
serial number per lot for traceability application check list
F. Some points recommended to be added in the SOP - Wear the safety protective
G. Prepare the medium in a container that have enough space to equipment
allow adequate mixing of media.
H. Wear the safety protective equipment (refer to MSDS).
I. Use a calibrated balance.
J. Add 1/3 of the required volume of purified water in the Human error Updating of the LSOP-03- 12/2022
preparation container, followed by the weighed quantity of due to 034adding the following :
medium and agitate briskly for a few minutes until a deficiency of Add 1/3 of the required volume
4.4 homogeneous suspension is revision ,add of purified water in the
obtained then add the remaining water, ensuring any medium that ition by preparation container, followed

The steps that
Assessment by
Timeline
inspector
annexes) taken
has adhered to the wall of the flask is added to the liquid. auditor for by the weighed quantity of
K. Use calibrated pH meter device. improvemen medium and agitate briskly for
L. Use calibrated and valid autoclave device. t a few minutes until a
M. Storage of the media in the autoclave after the liquid cycle is homogeneous suspension is
completed is not recommended after cooling, as it may damage obtained then add the
the media. remaining water, ensuring any
N. Clause No. 7-1-6 should come after the sterilization step. medium that has adhered to the
O. In clause 7.3.1, the name of the test should be changed from wall of the flask is added to the
test for -ve control to be sterility test liquid
- Use calibrated pH meter
device
- Use calibrated and valid
autoclave device
-changing test for -ve control to
be sterility test
F. Traceability
1. Critical
2. Major
Traceability in Warehouse WHO Technical Report Human Study will be in summer and Done
A. Data logger thermos-hydrometer No. STKRH-02 was not error due to winter to
recording lack of
B. Thermal mapping was made in summer only 7/2021 supervision
from
2.1.
supervisor ,
summer
Traceability in Production Human The balance in the weighing Dec 2022
The balance in the weighing booth was not fixed and it can easily error due to booth will fixed
2.2. move on the table deficiency of
reviewing
guidelines

The steps that
Assessment by
Timeline
inspector
annexes) taken
Traceability in Quality Control Human error Sending all document to Dec 2022
Specs are issued by QC and not document controlled due to lack documentation department to
2.3. of GDP stamp with DC stamper (on
training growing )
3. Other
General Human error GDP training was done Done
3.1. A. Delay of documents retrieval. due to lack
B. Overwriting in batch record of Omegaseef of GDP
3.2. Traceability in warehouse training
A. General There is an ------------------- ------------

▪ No interlock between doors in finished products warehouse. interlock
between
shipping
doors in the
finished
product
warehouses
▪ Interlock in warehouse can be disabled This option This option will be cancelled 12/2022
was added to
be used in
the
emergency
▪ No temperature or humidity monitoring in the warehouse Human error temperature or humidity will Dec 2022
receiving area. due to be monitored
deficiency of
▪ Flies’ zapper was not working. following up Change the old one with new Done
by HSE electrical insect killer

The steps that
Assessment by
Timeline
inspector
annexes) taken
▪ No follow up sheet for the flies’ zapper. department Check is performed according Done
to SOP
B. Release area: Human It was only one batch (not Done
▪ No identification labels on released batches. error due to batches) as mentioned in the
deficiency of finding and this may happened
final revision during handling or this batch
by Release was not released yet and this
department issue is fully secured by the
electronic system which
prevent shipping except
released batches.
▪ Open box was found in released batch. Human error Assuring procedure for Done
due to checking boxes before
deficiency of receiving from production
final revision
▪ Omegaseef batch No. 203237 with no label released. Human Assuring procedure for done
error in checking labels between
following release department and
GSP and warehouse
GDP
instructions
C. Returned products stored in the same place with the finished We have a Q1/2023
products. special For more control we already
location for issued a request to add new
the recall racks to be completely
and returns separated and closed for this
which is purpose
identified

The steps that
Assessment by
Timeline
inspector
annexes) taken
physically
This location
is
completely
controlled
and secured
by the
electronic
system so no
need for
complete
physical
separation
D. Quarantine products stored in the same place with released The reason Full identification label to be
products. was issued for physically secure the
E. Some of released batches are stored in the same place of warehouse situation 12/2022
quarantine in ground floor of racks over stock
Procedure to be issued for
covering this issue
F. No fumigation was performed for the wooden pallets. Deficiency we already in a contract 01/2023
in applying progress with a fumigation
GMP company
Instructions
Issuing a new SOP for
controlling the fumigation
procedure

The steps that
Assessment by
Timeline
inspector
annexes) taken
G. Incorrect location for data loggers in comparison with plan. Human Data logger will be located in 12/2022
H. Data logger No 43 was not found in the warehouse. error due to wright location
lack of
revision
of plan
I. No SOP for dealing with spillage. SOP In case there was any spillage
existing in we will contact with HSE to
HSE take action
department
J. Overwriting and Obliteration in receipt No 200100658, writing Human error GDP training will be done Done
mistake in form No. WSOP-01-003-04 written (From) due to lack
of GDP
training
Traceability in Production Human GMP , GDP training will be Done

A. Gowning area error due to done
- No label on antiseptic solution (identification and expiry date) lack of GMP
-No SOP for gowning in gowning area or posters describing the and GDP Gowning SOP will be issued
right way for gowning training
- Differential pressure gages are not labelled with specs limits or -request has been sent for
alert limits engineering for identification
label to be added
B. Dispensing area Human -rewriting for logbook Done

 Wrong spelling on the identification of logbook (Oil wighing error due to identification
looook) deficiency of more control will be considered
 The area of the weighing booth is not enough for the personnel reviewing -area will be extended
3.18. to move easily and need more space guidelines
 Batch cages are rusty

The steps that
Assessment by
Timeline
inspector
annexes) taken
 Thermo-hygrometer in oil weighing room is not calibrated -request has been sent for Budget
 Nitrogen supply in oil weighing room has no gages on it to engineering for Thermo- approval
record differential pressure hygrometer calibration
 No sheets to record daily verification of balances with the -request has been sent to Q1/2023
specs against the actual reading of the balance to record the engineering for adding a gauge
variance against the acceptance criteria on nitrogen line
-a sheet will be issued to
contain specs and the actual 12/2023
reading
C. Gelatin Human error a sheet will be issued to contain 12/2022
 No sheets to record daily verification of balances with the due to specs and the actual reading
specs against the actual reading of the deficiency of
balance to record the variance against the acceptance criteria. reviewing -repainting for red line and a
 No red line before the doors and sensors are not working well guidelines sensor will be changed with Q1/2023
and personnel need to go very close to the sensor to open other sensitive one
D. Encapsulation Lack of -request sent to engineering for 02/2023

 Tools under ladder to mezzanine are covered with plastic sheet following coving , epoxy maintenance to
 Covings & epoxy need maintenance GMP install a door under mezzanine
 No full separation between encapsulation machines and may requirements ladder
cause cross contamination and risk is not fully estimated -study on going adding
physical separation between
machines
E. Visual inspection and waiting area Lack of Capsules will be inspected 02/2023
 Depth card (depth label) is in direct contact with the product following inside plastic pages to be
GMP

The steps that
Assessment by
Timeline
inspector
annexes) taken
requirements separated from arounds
F. Production documentation Human error GDP training will be done Done

 No logbooks and instead data are recorded in paper data sheet due to lack
 Overwriting in most data sheets & missing part in dispensing l of GDP
data sheet training
3.4. Traceability in Quality Control
A. Overwriting in the form of receiving sample (Form No.: Human error GDP training will be done Done
LSOP-00-017-01), it has no serial no., and due to lack
3.4.1. this form needs to be a logbook instead of data-sheet file. of Sending a request for repairing
B. HPLC, Code: INIP-11 is under maintenance and the label is knowledge HPLC , sign the label with date
not signed and no date or time of GDP and time following GDP 12/2022
C. QC chemical lab cleaning form is copied with unclear form requirements
no., and it has no serial No., contains over-writing and was not 12/2022
signed for approval with date and time.
D. There is no IPC analysis for some products with no There is not d. long term study will be made Q2/2023
justification. enough on this issue
analysts or
instruments
E. QC has no thermal mapping. Human Thermal mapping will be Q2/2023

error due to considered in winter and
deficiency of summer
reviewing
guidelines
F. Data logger No. 53 was not in place in the raw materials Human error

The steps that
Assessment by
Timeline
inspector
annexes) taken
warehouse. due to lack Data logger will be places in 1/2023
G. Logbook of bulk products retained samples archive reviewed of following wright place
by column is empty. data integrity
and GD And full data will be completed
practices
H. BMS sensors were malfunctioned BMS Sensors will be fixed Q2/2023

system in according to a plan
installation
step (IQ)
4. Comments
G. Health, Safety, and Environment
1. Critical
2. Major
Absence of industrial sewage treatment plant Due to big we do study and the project Budget
2.1. budget was stopped because it was refused
very expensive (1500000 L.E)
2.2. Safety committee meeting was not held Done Done

The steps that
Assessment by
Timeline
inspector
annexes) taken
Defect in Log out – Tag Out system was not implemented no response we made purchasing request Dec 2022
from EP_1018/21 , SP_ 1302/20 and
engineering they refuse to supply technical
department support to purchase his needs .
and factory
manager to
applied this
2.3.
system from
2019 tell
Policy procedure was not found Deficiency Issuing new SOP Dec 2022
in following
2.4. GMP
instructions
Cold and hot work permits incomplete data and methods. Human error we send to change sop Done
due to lack osop_01_006 that responsible
2.5. of reviewing for hot and cold work permits
guidelines from 26/12/2021
Fire system of pump room is not effective Human error we solve the defect by change Done
due to the position and place of valve
deficiency of of fire system to work with
2.6.
followin effective action
Waiting for
2.7. Foam system boilers were not effective under study Dec 2022
budget
approval for
2.8. No fire alarm system Waiting for system under progress Q1/2023
budget
2.9. Co2 system in stability laboratory is not effective and unsafe and approval for CO2 system eliminated and
Human error Done
needs to assist before being rived due to lack substituted by manual fire
of reviewing extinguishers according to
guidelines standard

The steps that
Assessment by
Timeline
inspector
annexes) taken
No diesel fire pump was found Waiting for service request no 173869 to do Dec 2022
2.10. budget this process Need budget
approval for
3. Other
system
3.1. PPE SOP was not found SOP in PPE SOP already prepared and Done
preparing waiting for approval
3.2. Work permit index was not found step
Human error Done Done
3.3. Pedestrian paths were not found due to lack under progress Done
of reviewing
Risk assessment must be conducted by a committee not guidelines under study Done
3.4. individuality
4. Comments
H. Production
1. Critical
2. Major
General notes
A. The ID label for differential pressure gauge in some areas Human Check sheet will be issued for Dec 2022
contains the actions limit only without mentioning the alert error due to temperature and humidity
limits. deficiency of follow up
B. No in-place monitoring for the differential pressure, relative following up
humidity, and temperature in the area. it is conducted twice per Issuing a procedure for
2.1. shift by engineering only. informing engineering
department in case there were

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Most of temperature and relative humidity devices are not Delay of any deviation
working and the calibration tags of most are absence or the device budget
is absence (printing room 2- dispensing room of medicine). approval -contacting with engineering
D. No in-place instructions for notifying the engineering in case department (work order)
of any deviation in differential pressure or temperature excursion. informing about devices out of
E. Most of the differential pressure devices are out of order with range
no calibration tag (ex. Preparation room 2, Medicine Oil
Weighing room). Done
F. The differential pressure between class –D and Air lock of
class-C is 5 Pa and no limit is found on the gauge.
Done
G. The A/C return grill in the production is office type and some Human error request has been sent to Q1/2023
of them are damage (ex. preparation room (2)). The air lock due to engineering for reviewing the
between cleaning room and production rooms is used as deficiency of suitable grill
cleaned equipment while the cleaning room is used as drying reviewing
room. guidelines
H. No shrink for the cleaned tools which presence is the dry area. Cleaned tools will be covered Done
with shrink
I. PSOP-02-0001 mentioned that using of sterile water while no Updating SOP to including Dec 2022
WFI in the area, no drying steps was mentioned in the SOP and drying step , no disinfection
no disinfection steps for the tools/equipment. steps
J. PSOP-02-003 was not including step for inspection of hoses Updating SOP to include: Dec 2022
after/before cleaning and no
disinfectant for it and no method for cleaning of new hoses. step for inspection of hoses
after/before cleaning

The steps that
Assessment by
Timeline
inspector
annexes) taken
Dispensing process was deficient in that Human Contacting with engineering Dec 2022
A. No monitoring for the air speed of the weighing booth and the error due to department to :
gauge of the air speed is out of order. deficiency of Changing sodium lamp
B. The sodium lamp is fixed outside the weighing booth in room following up location
(3). and Weighing booth air speed need
C. The worktop in the weighing booth is not perforated which reviewing to be reviewed
2.8. obstructs the laminar of LAF guidelines -Issuing SOP for Fabtec
D. No SOP for Fabtec weighing booth weighing booth
Preparation process was deficient in that Human A tanks filled with prepared Jan 2023
A. Each prepared medicine batch is divided into two tanks error due to medicine will be covered
with no shrink for these tanks which introduce a potential deficiency of
risk for the mix-up and cross-contamination. reviewing B a risk assessment will be
B. No risk assessment for the preparation of food GMP issued
2.9. supplement products on pharmaceutical machine requirements
Encapsulation process was deficient in that

A. No physical separation for the different batches in the drying Human under study due to tunnel Q1-2023
tunnel. error due to extension waiting Budget
B. No line-clearance in case of batch changeover is done. deficiency of approval
Cleaning validation study is
reviewing present
GMP
C. The encapsulation machine is not fully coved, and the product requirements under study Dec 2022
is exposed the environment of other products.
D. The capsules after drying step are packaging in plastic depth Plastic pages are already tested Dec 2022
which has potential micro contamination risk. microbiologically before use
E. No dedicated hoses for the encapsulation machine for different Cleaning validation study is
2.10. products or different gelatin colors. Human present

The steps that
Assessment by
Timeline
inspector
annexes) taken
F. Some critical parameters were missed as the following: error due to request has been sent to Mar 2023
o The stroke gage is not calibrated. deficiency of engineering to take into
o The time of drying rotating. reviewing account : calibration of stroke
o No limits for adjusting Maglia oil pump. GMP gage
o Encapsulation 4, the calibration tag of temperature of cooler is
requirements o The time of drying rotating.
missed o No limits for adjusting
Maglia oil pump.
G. The hopper of the machinepex is not covered and the product Machimpex area is controlled
is exposed to the environment. following GMP requirements
for class c
Printing, polishing and Blistering process was deficient in that

A. Uhlmann blistering machine, no identification for machine Deficiency Uhlman blistering machine, Dec 2022
parts and no dedicated brush. of will be identified for machine
knowledge parts and dedicated brush
of GMP
B. The ink used in the printing of the capsule has expiration Deficiency The ink used in the printing of Q1 - 2023
period shorter than the expiration period of in guideline the capsule will be studied to
the capsule. awareness check the effect of print
C. The interlock of the pass box is not work in Uhlman blistering Delay of material
the pass box will be change to Q2-2023
room. budget dynamic system
D. Presence of dirty rags in the polishing room with no Deficiency Issuing ID label Done
identification label for status. of Update SOP
2.18. knowledge
of GMP
2.23. Packaging area was deficient in:
A. The presence of slot between the blistering room and Delay of request has been sent to Q2 2023
packaging room with no differential pressure in Klockner and budget engineering waiting for budget
Cam line. approval

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. The inkjet printing machine is without door and containing Delay of request has been sent to Q2 2023
terminal filters. budget engineering waiting for budget
approval
C. No par code sensor or check weighed on the Klockner or Cam Deficiency par code sensor on the Q1-2023
packaging machine of Klockner or Cam packaging
knowledge machine will be studied
of GDP
D. The material flow of primary packaging is through the Design primary and secondary packing
secondary packaging corridor problem are separated using double
Polly ethylene bags (control)

The steps that
Assessment by
Timeline
inspector
annexes) taken
2.28. Equipment maintenance Deficiency Done Jun 2023
A. Maintenance plan of
 Maintenance service plan 2022 is not a controlled form (neither knowledge
code nor version number was of GDP
found for it & the form was different from the issued form in the
maintenance SOP) although
it is approved by QA manager
 By comparing the machines listed in maintenance service plan
2022 with the equipment list  will be add
issued in the site master file there were many differences: Deficiency
1- Offline aggregation machines A&B & Dust collector No. 4 of Jun 2023
were found in maintenance knowledge
service plan 2022 but not listed in QA equipment list of GDP
2- The same machine with different name in maintenance service
plan 2022 than in QA
equipment list e.g. Stone mill Techno in QA equipment list while
the same machine was named colloidal stone mill in maintenance  will be change Jun 2023
service plan 2022
Deficiency
of
knowledge
of GDP
B. Maintenance SOPs: the used SOPs in machines maintenance Deficiency Updating SOP Jun 2023
were invalid for example: of
 Encapsulation SOP No. ESOP-04-017 version 01 issue date knowledge ESOP-04-017
13/09/2018& the revision date was 13/09/2021 of GMP
 Yestral Mixer Sop No. ESOP-04-008 version 01 issue date ESOP-04-008
26/10/2014, the revision date was 26/10/2017 & it was extended
validity till 26/10/2020 while it still used by engineering
department for machine maintenance

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Maintenance implementation Deficiency Maintenance will be Jan 2023
 Preventive maintenance for many machines were not done in guideline implement
according to the plan & no deviation report was issued e.g. awareness accurate
i. Dust collector#4 not implemented in December 2021
ii. The following machines were not maintained during 2021 plan
1. Capsule counter King M/C,
2. Capsule Jar capping AISA M/C
3. Capsule labeling NEWMAN M/C
4. Markem-Image 9020
 Encapsulation#1 according to maintenance service plan 2022
should be maintained each
720HRs while the recorded reading in last maintenance was
91205HRs & the actual reading
during the audit was 92375 HRs so the machine exceeds the max.
operation hours without
maintenance or issuing of deviation report
c.By reviewing layouts, the following was deficient

A. Blistering, Cartooning, and printing rooms were opening Deficiency Door closer will be installed Done
toward less pressure in guideline
awareness
B. Weighing interlock pressure was 30 Pa (Dusty operation) Deficiency Re adjustment for delta P Done
which open to medicine preparation also 30Pa in guideline
awareness
C. All rooms in layout are not coded Deficiency Adding room codes Done
in guideline
awareness

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. Layout has no change history for the update of the new version Deficiency Updating layout Done
in guideline
awareness
E. Washing room waste flow was toward cleaned equipment Deficiency Changing waste flow toward Done
room then the Gelatin weighing room of unclean area
knowledge
of GMP
F. Tool room & gowning AL waste was toward weighing Deficiency Changing waste flow toward Done
interlock & medicine preparation of unclean area
knowledge
of GMP
2. Other
a.General notes
A. Presence of unidentified pipelines in the washing room. Deficiency unidentified pipelines will Dec -2022
of identified
knowledge
of GMP
B. No differential pressure gauge between the second floor and Deficiency differential pressure gauge Dec -2022
ground floor elevator. of between the second floor and
knowledge ground floor elevator will be
of GMP installed in new BMS
C. Machine procedures was not differentiated between the major Deficiency Machine procedures will be Dec -2022
clean or other clean (Ex. Turbula, Cowles, encapsulation). of differentiated between the
knowledge major clean or other clean
of GDP Turbula, Cowles, encapsulation

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. No Q.C test was done for the detergent used in the laundry. Deficiency of Q.C test for the detergent used Q1-2023
knowledge of in the laundry will go under
GMP study to be controlled
E. The cupboard in the class-C gowning room is not sealed in the Deficiency of The cupboard in the class-C Q1-2023
partition and there is a potential risk for recess. knowledge of gowning room will be sealed
GMP
F. The interlock in the class-C gowning room is not working. Done
G. Presence of rust on the movable base of most of tanks. Deficiency movable base of tanks will be Q1-2023
of erased successfully
knowledge
H. The attached labels on the products or cages of the material of GMP
Deficiency The attached labels on the Q1-2023
can be easily detached. of products or cages of the
knowledge material can will go under
of GMP study be not easily detached
j.Dispensing process was deficient in that
A. Presence of cartons in the MAL between the warehouse and Deficiency Done
dispensing area for medicine. of
knowledge
B. The storage of premix is in the Air Lock area (class C) for of GMP
Deficiency Done
medicine. of
knowledge
C. No daily check for the pallet scale in Medicine Oil Weighing Deficiency Done
room. in following
D. No dedicated scoop for each dispensed API GMP Not applicable because we
have a lot of API components
in soft gelatine capsules but
this process under control
E. No area for dispensing of volatile material of some products Factory old Will be study Q2-2023
(ex. Urinex) design

The steps that
Assessment by
Timeline
inspector
annexes) taken
F. PSOP-03-037 of Kern balance is not mentioned the serial Deficiency in Done
number of balance and not contained daily check form. following GMP
instructions
Preparation process was deficient in that
A. The tanks covers are scratched with incomplete welding Deficiency in tanks covers will be reviewed Q1-2023
following GMP successfully for this issue
instructions
B. The area between the dispensing and the preparation is used as Deficiency in staging area.is separated from
staging area. following GMP dispensing and preparation as
instructions
require and the area is narrow
C. No physical separation between the dispensed material and Deficiency in Done
prepared medicine which have potential following GMP
instructions
risk of cross contamination.
D. No checks for the dispensed materials before preparation Deficiency in Done

however the holding time is 7 weeks. following GMP
instructions
E. No dedicated sieves or hoses for different product in the Not applicable because we
preparation are of medicine have a lot of components in
soft gelatine capsules but this
process under control
F. Presence of unusable vapour and chillier hoses in the medicine Deficiency Done
predation staging area in following
GMP
instructions
q.

The steps that
Assessment by
Timeline
inspector
annexes) taken
Encapsulation process was deficient in that
A. The weight of capsule is checked every one hour and is not The weight of capsule is
performed for all the nozzle of machine in each check. checked for all the nozzle of
machine in the start of
production and after one hour
for 2 capsule one from right
side and the other from another
side as a indication for med
pump
B. No monitoring for critical parameters in the tunnel as air Deficiency in air speed. Are monitoring by
speed. following third party periodically
instructions of
GEP
C. No differential pressure gauge on the pass box between the Deficiency of Bass box will be change for Q2-2023
machinepex and the cartooning area. knowledge of dynamic one but waiting for
GMP approval budget
D. The form of preparation of coating solution (formalization) is Deficiency of Done
x.
not controlled. knowledge of
GMP
cc.
Printing, polishing and Blistering process was deficient in that
A. Lot number of the ink used is not recorded in the batch record. Deficiency of Done
knowledge of
GMP
B. No automatic inspection camera on the CAM blistering Delay of budget Waiting of budget approval Q2-2023
machine.
C. The container of ink in the capsule printing machine is not Human error in Done
covered. following GMP
instructions

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. Presence ISO propyl tank in the polishing room inside the Deficiency in Done
printing room 2 have ID label without some data for following
concentration or expiry or lot no and also mentioned in SOP GMP
#PSOP-07-032. instructions
E. No differential pressure gauge between the polishing room and Deficiency of differential pressure gauge will Q1-2023
printing room. knowledge of be considering
GEP
F. Coating room (polishing), presence of cylinder used for Deficiency of Done

dispensing is not of coating materials knowledge of
GMP
3. Comments
a.N/A N/A N/A N/A N/A N/A
b.
N/A N/A N/A N/A N/A N/A
I. Warehouses
1. Critical
2. Major
2.1. A. There is no procedure for gowning in warehouse Deficiency Procedure to be issued to Dec-22
of cover the suitable protective
knowledge garments appropriate for the
of GDP activities they perform
B. There are no instructions to prohibit eating, drinking, chewing, Deficiency Instruction to be added to the Dec-22
smoking or the storage of food, drink,smoking materials or of gowning procedure to consider
personal medication. knowledge this issues
of GMP

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. There is no approved suppliers list in the warehouse, and Deficiency Check list to be modified
check list form# WSOP-01-003-04 has no check for received of considering the approved Dec-22
material is from approved supplier. knowledge supplier list after receiving the
of GMP approved supplier list from QA
D. Layout LO-003 version# 7 is not controlled (by QA stamp) Deficiency Layout LO-003 version# 7 will Dec -2022
and has no history of changes. of be controlled (by QA stamp)
knowledge
of GDP
E. Identification labels are not controlled form such as waste, Deficiency
Procedure to be issued for Dec-22
returned, etc. of
knowledge covering this issue
of GDP
F. SOP (WSOP-00-001) did not mention the types of used Deficiency
disinfectants alternately, nor the concentration of soap and how it of Update the SOP to include
is prepared. knowledge more details about the Jan-23
of GDP cleaning solution
G. PQ of sampling booth is not approved by safe pharma staff Deficiency sampling booth will approved Q1-2023
of by safe pharma staff
knowledge
of GMP

The steps that
Assessment by
Timeline
inspector
annexes) taken
H. Training Deficiency 1- Actually it was one
 There is no training on any SOP for Mr. Kareem Yahia of procedure with no signature
 Tech. Salama was not trained on SOP# (WSOP-00- , ( ‫خطوات‬ knowledge for Kareem but the other
001 ‫تنظيف ومتابعة وصيانة المخازن‬ of GDP concerned SOPs has his
although he is the responsible person for cleaning signature done
2- SOPs training records to be
revised for missed training for
re-train and complete the
missed employees' signatures.
A. Temperature and relative humidity were not monitored in the Deficiency 1- this area was considered in Done
receiving area where RM was stored ex: in GDP the temperatue mapping last
Pharmaceutical gelatin supplier batch# 113/222 & supplier awareness study to control it
recommendation is "store in dry place".
B. Manual records of temp. and relative humidity recording is 2- we already aim to change Jan-23
done in form# ESOP03-019-01 as a this area from being receiving
separate sheet not bounded logbook. area to be storage area and
projects request was issued
2.9.
2.10. A. Lighting is not appropriate in receiving, RM and PM storage Deficiency Lighting will appropriate in Jan-23
areas, and it is difficult to read data of materials. in GSP receiving, RM and PM storage
awareness areas, and it is difficult to read
data of materials.
B. Compressed gas cylinders beside warehouse are dusty and not Deficiency Compressed gas cylinders Dec 2022
clean and their identification labels are torn. in GMP beside warehouse will be
awareness cleaned and identified

The steps that
Assessment by
Timeline
inspector
annexes) taken
C. Pest control was deficient in Deficiency Pest control will be consider all Dec 2022
 There was no pest control map in the warehouse in guideline of items  pest control map in
 rodents bait unit #67 but its number in follow up sheet was 46 awareness the warehouse
 rodents bait unit #72 its follow up sheet is without number and  rodents identification
there were some missing  Insect killers
recorded data such as year, date of check
 rodents bait unit #11 there were some missing recorded data
such as year, date of check in its follow up sheet
 There were two Insect killers in receiving area: The first one
has no number and its follow up
sheet is signed without date; the second one has no number
although its follow up sheet has number 13.
2.14. A. Receiving and dispatch bays are not protected from weather Deficiency We already issued a request Jan 2023
in GSP for cover this area to be the
awareness new receiving area and we are
waiting for pricing and financial

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. There was no segregated area for return and recall products. Deficiency 2- This location is completely Jan 2023
in GSP controlled and secured by the
awareness electronic system so no need
C. There were big cracks and holes in the floor of PM, and there Deficiency forFor
3- complete physical
more control we already
is a long open drain. in GMP Mar-23
issued a request to add new
awareness racks to be completely
separated and closed for this
purpose .
D. The wall in PM is damaged affected by moist beside door Deficiency Considered in the maintenance
P/GC/06. in GMP plan Q2-2023
awareness
E. There was a small leakage in the wall of cooling area 1. Delay of Waiting for budget approval
F. There were some cracks in the receiving area. budget
Q2-2023
approval
G. Differential pressure gauge in the personal entrance of Done
sampling room was not sealed (there is a hole around it), and
there were no limits on it.

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. There was no risk assessment for handling RM from RM Deficiency risk assessment for handling Dec -2022
warehouse to production (medicine door) as materials transferred in GMP RM from RM warehouse to
from unclassified area to class C direct through one air lock class awareness production will be done
D (with the same gowning in classes C & D) and procedures to
prevent contamination during materials handling
was not illustrated.
B. Waste material exit was the same of RM entrance to Deficiency It is a design defect and is Dec -2022
production. in GMP controlled through time
awareness separation and we recommend
for this to be identified in the
corresponding production SOP
C. There were some plastic pallets in FP warehouse similar to Deficiency Production dep will sent Q1 2023
those using in production without differentiation between them by in GMP request a new pallets with
color and in procedures awareness different color to be clearey
2.21.
identified and prevent mix up
For sampling tools, there is a risk of contamination of sampled Done
materials as the sampling tools are not double wrapped to be
protected before entrance to classified sampling room, nor
sterilized to minimize
2.24. microbial count.
2.25. A. There were no monitoring and recording of differential Delay of Waiting for budget approval Q1-2023
pressure gauges of sampling booth filters before each sampling budget
process. approval

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. Environmental monitoring logbook Form# LSOP-00-016-04 Deficiency B. Environmental monitoring Q1-2023
was not serialized. in GDP logbook Form# LSOP-00-016-
awareness will be serialized.
C. Cleaning status label form#LSOP-01-020-01 was signed done Deficiency Cleaning status label Dec -2022
by and checked (by computer) on the same label not manually. in GDP form#LSOP-01-020-01 will be
awareness corrected
D. SOP for using balance Radwag NRM-38 in the sampling room Done
was not present beside the balance.
E. In the PQ certificate of sampling booth, it was mentioned the Deficiency PQ certificate of sampling Dec -2022
code is SRWB/SR while in page#4/34 the code is(A) and the in GDP booth will be correct
model was SRWB/SR (which was correct?) awareness
3. Other
There was no access control for personnel entrance to warehouse Deficiency We already issue a request and Dec -2022
to prevent the entry of unauthorized people. in GMP waiting for pricing and
3.1. awareness approval for implementation
3.2. Records of temp. and RH% monitoring was deficient in that
A. FP (data logger SN# A17120335) and RM (data logger SN# Human a new SOP was done for
A17120352) warehouses, some readings were more than 65% error due to temperature and humidity
during August 2021 without issuing a deviation report deficiency of monitoring by warehouses
following up

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. There were no records for days 30/8/2021 &31/82021 for both Human error a new SOP was done for
areas. Also temp. and due to temperature and humidity
deficiency of monitoring by warehouses
following up
C. RH'% in storage areas were not controlled by BMS. Deficiency a new SOP was done for
in GSP temperature and humidity
D. There was no records for monitoring temp and RH% in PM Human error a new SOP was done for
storage area for 8/2021 due to temperature and humidity
deficiency of
following up monitoring by warehouses
E. There were no records for monitoring differential pressure in Human error Done
air locks between warehouse and production. due to
deficiency in
reviewing
guideline
3.8. A. Receiving area was deficient in Deficiency of Done
 There was a weighing booth which is not identified nor coded. knowledge of
GSP
 There were some empty, not identified containers
B. There was no system for routine internal verification of Human error 1- We already make self Q1-2023
balances Defender 300 and Ohous R41 used for weighing RM. due to calibration
deficiency in
reviewing 2- PO for calibration weights to
guideline make daily verification for
balances
C. There were no codes on equipment such as the sampling booth Deficiency A new labels will be added Q1-2023
in the sampling room. in GMP for identification

The steps that
Assessment by
Timeline
inspector
annexes) taken
D. The AHU pipelines were not identified, grills in the warehouse Deficiency A new labels will be added for Q1-2023
are not identified supply or return. of identification
knowledge
of GMP
E. Manual records of Temp. and relative humidity Recording was Deficiency Retraining will be done on Q1-2023
done in form# ESOP03-019-01 as a separate sheet of GDP
knowledge
of GDP
F. In SOP#WSOP-01-003, it was mentioned in item#7-1:" All Deficiency Not all containers to be Q1-2023
received containers were weighed by warehouse-keeper " but of weighed and this to be clarified
actually not done, so a risk assessment is needed. knowledge in the SOP and assessment of
of GDP the risk if required
G. Forms# ESOP-03-019-01 &ESOP-03-019-02 for temp. and Deficiency Updating for sops Q1-2023
relative humidity record for RM and FP of
warehouses respectively max allowable RH% is 65 although the knowledge ESOP-03-019-01 &ESOP-03-
definition of " protect from of GDP 019-02
moisture" means not more than 60%
A. RM Containers were not shrinked on pallets to prevent mix up. Deficiency A new labels will be added for Q1-2023
of identification
knowledge
of GMP
B. Some printed PM are stored outside the secured area ex: Alum Delay for Baskets on the floor will be Q1-2023
Mentholax (Romania) lot# 200300223 budget replaced with another boxes
3.15. approval attached to the wall to avoid
contamination

The steps that
Assessment by
Timeline
inspector
annexes) taken
A. There were some products in rejected area identified by Deficiency SOP to be modified to Q1-2023
released label such as Omegaseef BN: 17221, and other product of clarify the labelling of
not identified by rejected label such as Calmseef BN: 17116 knowledge expired retail products and
of GDP rejected bulk products
B. There are some Semi-finished products not identified by reject Deficiency SOP to be modified to clarify Dec-2022
label such as Neurimax capsules BN: 221305. of the labeling of expired retail
knowledge products and rejected bulk
of GDP products
C. Cleaning label on RM container of Refined Glycerin 99.7% Deficiency Retraining will be done to the Q1-2023
supplier batch# 69231form# WSOP-01-002-02 is not manually in GDP technician
signed by tech. Ahmed Hany and without checked by another training
person and date is recorded in the row of done by
3.17.
All containers of Refined Glycerin 99.7% supplier batch# 69231 Delay for The yellow tape is attached to Q1-2023
are labeled "sampled"; however the actual sampled container is budget only the containers from which
marked by yellow tape and there is no label "quarantine" on any approval the sample was taken but the
container. rest containers has a sampled
label which considered
3.20.
quarantine status
3.21. A. A lot of rust in the drawers’ unit (need to be replaced by a new Delay for Baskets on the floor will be Q1-2023
one) in the sampling room. budget replaced with another boxes
approval attached to the wall to avoid
contamination

The steps that
Assessment by
Timeline
inspector
annexes) taken
B. Overhead and over shoes in the personal gowning of sampling Delay for Baskets on the floor will be Q1-2023
room are in baskets on the floor not budget replaced with another boxes
in a box on the wall. approval attached to the wall to avoid
contamination

4. Comments
J. Training.
1. Critical
2. Major
3. Other
3.1. Personnel training was deficient in that
A. The inspectors show practices that deviate from the issued Deficiency SOP will be Updated Q1-2023
SOP LSOP-02-005, there must be an exam for the SOP solved by of GDP
every trainee. knowledge
B. On job training exist for both QC & RD but not fully Lake of Retraining will be done with Q1-2023
implemented & require Improvement where a specific training knowledge the required improvement
should be given in case of using Computerized Systems. on GDP &
GMP
C. No on job training for Amr Abdel-Gawad, the training records Lake of Done
were not complete. knowledge
on GDP
D. On job training SOP not applied according to the plan Lake of Retraining for the newly hired Q1-2023
designed in LSOP-00-003 for newly hired personnel. training personnel
E. SOP: VSOP-03-002 Stability on job training exist but not Deficiency SOP will be Updated Q1-2023
effective & require more details. of GDP
knowledge

F. Training for the 2 Service Assistants required without any Lake of Retraining for the technicians Q1-2023
response from the lab [QC] training
G. Micro lab technician needs training on GDocP. Lake of Retraining for the technicians Q1-2023
training
4. Comments
4.1.
4.2.
The inter-company audit team will review the response & the audited company will be informed of the outcome of this assessment within 30 days
from the receipt of the detailed CAPAs. Please note that a follow-up audit may be required to verify the implementation and completion of the
corrective actions taken.
Approval for CAPA plan
Title Site QA Manager Corporate QA Manager
Name
Initial

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CAPA Reply for Audit Findings

Intercompany Audit Number ICA- - 00- 0000

aCompany SAFE Pharma

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

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2.6. Internal Auditing

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Supplier Qualification Deficiency Updating Supplier qualification Done

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Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

B. Control of HVAC system.

2.10 Change control system was deficient in that

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Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Company Profile Deficiency Company profile will be Q1/2023

Training lack of Attending TOT training (Corp Done

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Recall Deficiency Updating SOP QSOP-00-006 02/2023

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Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

J. According to SOP: ISOP-03-014 Deficiency Will be considered Q1/2023

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D. Validation & Qualification

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Process Validation SOP was deficient in

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Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Process Qualification Human error Actually revision is done with Done

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

- Lab. note book (LOP-

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

O. Not enough identifications on encapsulation machines (No

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Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…

Procedure: Intercompany Audit Form No.:C-QA-DC-PRO-005-07 Version 03 Page …of…