CAPA Tracker

MOH 1.1.The pressure for some areas was not presented on the layout for pressure.

MOH 1.2.Personnel flow diagram was incomplete.

1.3.Some Cupboard doors were having the same codes as the

MOH room doors
which may hinder traceability.

1.4.Some areas were misidentified at the layout. E.g.: Staging area

and
Storage Area. Tools stored in room identified as staging area room
MOH
&
staging actually occurs in the room identified as storage area
room.
1.5.There was no unified coding system for room coding. E.g. some
MOH rooms were
identified by function and others by the machine name.
MOH 1.6.Manufacturing area Classified D for Oral drops, Semisolid & Liquids.

MOH 1.7.PALs & MALs were not identified.

1.8.Room Name used in production area for some rooms was

different than that at layout.
MOH
E.g.: Room 90 in Production area was identified as Glatt Filter
BagStorage Room while not identified as that on layout

MOH 1.9.Waste flow was not illustrated on layout

MOH 1.10.There was no layout for the current classification of the production area

2.1. a.Receiving (handling & transferring) of dispensed raw

materials & 1rypackaging
materials (empty bottles & empty tubes) for all lines:
-Visual check for its shrink integrity,
MOH -Shrink removal procedure
-Action taken in a case of its tearing
-Instruction for palette change after receiving of raw material
-Its cleaning & disinfection before entering production area.

MOH b.Transferring & feeding of bulk intermediate to machines.

MOH d.Proper handling, transfer & storage of unclean and clean tools afterwashing

MOH e.Transferring of water from use points to production areas with no use points

MOH f.Operation procedures for each room.

MOH g.Waste disposable.

MOH h.Gowning.
MOH i.For cleaning in place

j.For the internal labeling, quarantine and storage of starting

MOH materials,packaging
materials and other materials, as appropriate.

2.2. a.Cleaning SOPs of machines needed to be more detailed to

include thefollowing:
-Visual check.
-some critical cleaning parameters ex. mechanical force, quantity
ofwater, quantity of detergent, name of detergent used &number
MOH
ofcleaning cycle.
-Procedure for cleaning of outer body (surface) of the machine.
-Differentiation & determination of machine movable parts
whichclean in place & clean out of place in washing room.

b.Tablet deformity photos were not mentioned in SOP code 015

forblistering check
MOH also the SOP missed to mention the qualification ofpersonnel
doing visual inspection

MOH 3.1. a. The number of AHUs was not mentioned.

MOH b. The BMS used was not mentioned as one of the validated computersystems.

MOH c. The P&ID for the water station was not attached

4.1. Ciprofar 500mg Tab Batch Number: 1655

MOH a.Expiry date or Retest date for Raw materials was not included
thedispensing sheet.

MOH b.There was no calculation sheet to compensate the assay of the API.

MOH c.There was no clean label attached to the batch record.

 d.There was no recording performed for the AP, RH%, &
MOH Temperatureof the room
before starting.

MOH e.Attached Blisters to the batch were not signed by the authorizedperson.

4.2. Ciprofar 500mg tablet BN: 1667

a.There was no challenge test for metal detector recorded in batch
MOH
recordex at
compression machine (tablet press) room no.43

MOH 5.1. Was missing walls, ceiling & floors maintained for each room
separately.

MOH 6.1. a. Maximum holding times of intermediates of moisture

sensitive andphotosensitive products were not validated.

MOH b. Was not done for suppository, effervescence Powder & liquid dosage form.

c. Samples taken were not clarifying or representing holding time

MOH fortotal batch
just samples at each step.

d. Protocol of the study was not clarified steps

MOH - Long term study.
- Only one batch

7.1.
a.Referring to retained samples
b. Mini tab format.
c.Assessment for capability six packs
MOH d.Planned and actual date
e.List of equipment states
f.Justification for out of control results (PPK and PP of assay of
Cetraksyrup)
g.Comparison between current and previous study toward six
packs
 8.1. BMS (GT/PH/PQ/P/BMS -02) was missed in:
a. Justification for difference in monitoring range of differential
pressurebetween manual system and BMS system ex.: upper limit
for HEPAfilter 550 in manual and 500 in BMS system.
MOH b. Some sensors serial number.
c. Justification for difference in temperature between what actual
andwhat in protocol
ex.: production up to 30 in actual and up to 25 in protocol.

BMS (IT/WENG/003/11/2018) was missed in:

a. Report.
MOH b. Justification for difference in time between sensors challenges
study
(10/10/2019) and this study (28/11/2018).
c. Alarms assessment.
d. Security levels assessment.
e. System failure procedures
 1.1. Suppliers for the Disposable scoops used for the
dexamethasone product dispensing was not:
a. Covered by the supplier qualification.
b. Part of the plan.
c. There was no information about the number of suppliers for
thescoops, names or list of which
1.2. Some items were out of scope, e.g.
a.Reagent.
b.Media.
MOH
c.External services e.g. calibration....etc
1.3. The evaluation criteria of the supplier after approval need to
be more clarified & detailed, e.g.
a. Acceptance level (Lab only, lab & production, production).
b. Supplier response (very slow, slow, moderate, immediate,
noresponse).
c. Delivery time (in- time / delayed period).
d. Payment term (in advance, post-delivery) etc
1.4. The disqualification & requalification criteria need to be
detailed

2.1. Swab surface did not cover all production areas.

MOH 2.2. Viable & non-viable environmental monitoring didn't cover
main production
corridor class D

MOH 3.1. There was no procedure for air volume balance calculations
for every AHU & feeding area.

MOH 3.2. Air flow direction test was not done.

MOH 3.3. No. Of air changes named by mistake air flow test
3.4. There was no schematic diagram for AHU supplying washing
MOH area used for all
lines which hinder reviewing of its design & qualification

3.5. Volumes of corridors were not accurately calculated as its

very big, looped & its
MOH diffusers with the same air volume approximately were not risk
based approach
distributed

MOH 3.6. Particles count test location was not based on risk study
 MOH 3.7. electrostatic & ion generators test was not done

3.8. Dehumidifier was not included in qualification to guarantee

MOH (chemical dryer
didn’t become source of contamination efficiency of dryer, temp,
time, etc)

MOH 3.9. Dust collectors were not included in qualification

MOH 3.10. Air shower MAL in semisolid area was not qualified

4.1. Test for particles size was not done before & after filters
MOH
during qualification e.g. sand filters, micro filters....etc.

4.2. Samples were not taken & tests were not considered before
MOH & after
micro filters.

4.3. Degassing was not assessed & NaOH was not added without
MOH study or
justification.

MOH 4.4. Temperature at use points was not verified.

MOH 4.5. Flow rate was not validated.

MOH 4.6. Spray dispersion efficiency was not validated.

MOH 4.7. UV efficiency was not validated.

MOH 4.8. Validation of sanitization frequency was not done.

4.9. Limit of conductivity of purified water was very high 1.5

MOH micro which was not
complying with ISO 22519.

MOH 4.10. There was no sanitization study based on validation.

MOH 4.11. There is no alarm System.

5.1. PQ needed to be reviewed & finished for all equipment as it

MOH was not done for all equipment e.g. some blistering machine, dust
collector, inspection camera, metal detector, powder filling
machine
5.2. Protocol no (QA/VQ/P/PQ-020) was missing in:
MOH a. Revalidation schedule plan based on risk study.
b. Proving consistency as test results not collected over a suitable
periodof time
MOH 6.1 . There was no schematic diagram or photos to illustrate load
& data logger
distribution

MOH 6.2 . Air blowing for drying was not filtered

6.3 . Alarm & sampling locations were not comparable with the
MOH interpretation
data of temperature worst point

7.1 . Force of compression of punches was not qualified as a

MOH
critical parameter
related to hardness

8.1. S.O.P no (A/0/055) was missed in:

a. Detailed objectives ex.: process capability.
MOH
b. Revalidation schedule plan.
c. Type of program used for statistical study

8.2. Ciprofar 750 (QA/VQ/P/PV-055-01), Glycerin adult

(QA/VQ/P/PV148.01), Fawar fruit (QA/VQ/P/PV-135.02),
Cerebrocetam 400
(QA/VQ/P/PV-040.01) missed the Following:
a. Comparison study for two types of coating machines (Accela
and
manesty). As the process validation done only on manesty.
b. List of machines.
c. Milling done on different equipment without any consideration
MOH
for
difference in parameter sex. fitz mill, bohle, turbo sieve1).
d. Assessment for CPK and CP.
e. Difference in the speed of machine during Others
manufacturing of the
three batches as first batch speed was 1100, second was 1200 and
third
was 800 without any justification.
f. Statistical study for critical parameters.
 8.3. Report no (QA/VQ/R/PV-055-01), (QA/VQ/R/PV-148.01),
(QA/VQ/R/PV- 135.02), (QA/VQ/R/PV-040.01) missed the
following:
MOH
a. Justification for out of control results.
b. Record for temperature and humidity.

8.4. Process validation (Algason)

a. There’s no Statistical evaluation or assessment of the capability
of the
process (PPK)
b. The graphical representation was done for the assay only.
c. There was no risk analysis to cover at least the critical steps, in
process
testing was not risk based.
d. Environmental conditions didn’t specify.
MOH e. There was no review or comparison of the results with those
expected.
f. Sampling procedures details (e.g. the samples to be taken-
where,
when, how & how much or how many) was not clarified (There
was
no sampling plan or diagram.)
g. Serial numbers of laboratory instruments involved in the study
weren't
mentioned

MOH 9.1. S.O.P no (A/0/024) was

missed in:
a. Revalidation schedule plan based on risk assessment approach.
 9.2. Protocol no(QANQ/P/CV-027-02) for suppositories,
(QANQ/P/CV023) for dispensing, (CVP/014) for granules filling,
(CVP/008) for
liquid, (CVP/006) for
semisolid, (CVP/004) for tablets missed the following:
a. for detergent. The residual of cleaning agent was tested for PH
and
conductivity only (no specific method or TOC test).
b. Maximum dirty holding time, cleaning holding time, campaign
length
and time between cleaning and drying was not define.
MOH
c. Sampling procedures clarify the methods used (swap or rinse)
and
justification for their use.
d. Temperature of rinsed water during study was not recorded
that didn't
guarantee rinse samples are accurately recovered.
e. Documented evidence that routine cleaning and storage of
equipment
doesn't allow microbial proliferation.
f. No differentiation between minor and major cleaning

10.1. a. Personnel qualification.

MOH b. Analytical method validationno (A02-VA023-2017), (A02-VP003-
11.1 Protocol
2018) was missed in:

a. A comparison of the results of two studies

b. Detailed methodology (only site survey done).
MOH c. Interpreting the results and making recommendation.
d. Data and preliminary analysis.
e. It didn't carry out during the warmest and coldest season to
represent
the worst case scenarios and will establish whether the mapped
1. Complaint:
area is
1.1
able. to
The SOP forstable
maintain complaint did not mention
temperatures informing
throughout the
the year.
competent
f. Revalidation schedule plan based on risk study.
authorities if a manufacturer is considering action following
MOH
possibly
faulty manufacture, product deterioration, a suspect product or
any other
serious quality problems with a product
 2. Recall
2.1. a. SOP for recall did not mention:
- Recalling free medical samples and clinical trials.
- Notifying all competent authorities of all
countries.
MOH - Notifying media for prompted action in critical recall involving
life threatening condition as the SOP did not differentiate between
Critical and Major recall both having 2 days’ period for
notification.
b. Recalled Rani Batches were not in a secure segregated area.
c. Rani recall report mentioned as critical case (Closed after 30
days,
according to SOP it should be closed in 7 days).
d. Wholesalers only were informed and the recall did not involve
customers supplied directly
1. Internal Audit:
MOH 1.1. SOP missing detailed description of the audit team and the
lead auditor.
E.g.: years of experience for the lead Auditor

1. Personnel
1.1. Visual inspection operator's qualification was not done
appropriately, not
MOH
documented & not done on different challenges sets with different
defect
kits.

1.1. Single corridor general for all areas (SDF, Oral Drops, Liquid
MOH
Dosage
forms,) which may be increase probability of cross contamination.

1.2. Some areas had no MAL or PAL although it's directly opened
to one clean
common corridor for all lines flows e.g. solid, syrup & semisolid
lines e.g.
MOH powder filling room, vet, effervescence granules line, suppository
preparation & filling room.... etc

1.3. The same common flows e.g. raw & packaging material...etc.
for all
MOH
dosage forms

1.4. Most of the doors in the production area opened towards

MOH the less positive
side.
 MOH 1.5. There was no alarm in place for differential pressure out of
limits

1.6. Light source in stage area room no 102 was not well fitted or
MOH
sealed

MOH 1.7. Doors were not well fitted.

1.8. It was recorded as differential pressure gauges was Zero
checked although
actual reading during audit almost at the same time was less than
MOH zero in
air lock before entrance production area and after primary
Gowning .

1.9. 2ry gowning was not performed for all production areas some
areas had no
2ry gowning E.g. Powder Filling room 157, Suppository
preparation,
MOH Suppository Filling, & coating room 32, 31 although they were all
sharing
in one corridor

1.1. There was no:

a. System for vent filters change.
b. Monitoring for UV lamp.
MOH c. Risk study for possibility of water stagnation (ex.: after DI).
d. Sensors for return loop temperature on (PW tank2)
e. Acceptance limit for conductivity in log book.
f. Monitoring of differential pressure across filters.
 1.2. All use points contain cavity from inside which may lead to
MOH
contamination.

1.3. There was long flow without antimicrobial agent chlorine

MOH after carbon
filter till reach R.O. & passing through softeners.

2.1. There was no:

MOH a. Lower limit based on study for differential pressure across filters
(HEPA, Pre and bag filers).

b. Identification labels for ranges of different parameter e.g.

MOH differential
pressure.... etc.

MOH c. Procedure for changing and cleaning pre and bag filter.

MOH d. Procedure for restarting.

MOH e. Procedure for fan speed monitoring.

2.2. Dust collectors:

a. There were neither sops nor records for cleaning.
b. There were neither sops nor records for monitoring.
MOH c. There were neither sops nor records for maintenance.
d. There was no schematic diagram.
e. There was no calibration.
f. There was no alert or action limit for RH%

MOH

MOH
 2.3. Calibration label due date for sensors of (AHU5) was oct/2019
MOH and that's
out of date & no action was taken without any justification.

2.4. There were no Pressure gauges between pre & bag filter and
MOH for HEPA
filters for AHU of coating machine.

1.1. Daily verification was not covering operating range for all
balances more
over there was no log book for double check for weight or
recording for
weight of each weighed items
E.g. Balance B145427408 (Max. 600 Kg) available at the production
MOH
had
no logbook and the maximum daily verification for the balance
was 200Kg
in spite of using it to weigh more than 200Kg. e.g.: Ciprofar 500mg
Tab
Batch 1655 the same balance used to weight 250 Kg gross weight.

1.2. Technical areas & stairs were not qualified as class D although
MOH they were
opening to class D corridor.

1.3. Door 222 for the Technical room (inside production area) 122
MOH was not of a
controlled access and was poorly closed.

1.4. Measuring differential pressure through compressed air filter

was
MOH inappropriate & there was no method or SOP for calculating the
difference
between outlet & inlet of pressure

1.5. Humidity control for need that was no appropriate as:

a. Effervescent granules exposed to high long way transfer in
MOH nonhumidity controlled area till reach humidity controlled filling
area
without risk assessment.

b. Not all Cubicles, in which products requiring low relative

humidity
separated from adjacent areas with higher relative humidity by
MOH
means
of suitable airlocks.

MOH c. These steps were not considered in process validation & holding study
 1.6. There was no SOP for transferring of intermediate between
MOH areas
especially effervescent granules

1.7. The corridor pressure was more positive than all non-solid
MOH cubicles areas
(liquid, semisolid)

1.8. Primary Gowning Room (Classified D):

MOH a. There were no clear photos to illustrate the proper gowning.

b. The room walls and floor lined with ceramic tiles which hinder
clean
MOH ability (not smooth).

c. Parts of the ceiling were not fully sealed.

MOH
d. Primary gowning room needs maintenance for walls, ceiling &
MOH Cupboards.

e. Indoor & outdoor gowns were in the same place without even
separation
MOH

1.9. There was no differential pressure between some rooms

opening to
each other and the corridor.
a. 2ry gowning room 146 and corridor 150.
MOH b. Packaging and the 2ry gowning room.
c. Room 144 and Room 204

1.10. Janitor room Located under the stairs:

a. Room was not illustrated on the layout.
MOH b. There was no ventilation for the room although it was opening
directly
to class D area.

1.11. There was no Airlock between Classified rooms 64, 65 and

MOH unclassified
Raw Material Store.

MOH 1.12. Emergency doors were not sealed from all edges.
 1.13. Powder vacuum cleaner and water suction machine were
stored together
carrying no clean label and the water suction machine was clearly
not
MOH cleaned properly & not dedicated for certain area go to central
washing
room & return back , distributed again to different areas which
may be a
cause of cross contamination

MOH 1.14. Production area was not restricted to authorized persons.

1.15. There was neither interlock system nor Delta p monitoring

MOH between
unclassified and classified area in PAL.
MOH 1.16. Log sheets were not bounded
1.17. Sodium Lamp:
a. There was no operation Logbook
MOH b. It was not calibrated.
c. There was no Cleaning Logbook
d. There was no intensity check.

MOH

MOH 1.18. Torque test was not done for all bottles.

2.1. Single common Washing Bay for all production areas: Liquid,
MOH Semisolid,
etc.

MOH 2.2. Clean air lock was not bubble to the washing room and the corridor.

2.3. There was no disinfectant available at the drain available at

MOH the washing
room

2.4. The water collecting ducts were not slopping towards the
drain leading to
MOH
permanent stagnant water at the room even when no washing
performed.
MOH 2.5. Unclean drain full of debris & mud.

MOH 3.1. Electrical service for FBD was opened inside preparation room.

MOH 3.2. Manual feeding technique was applied which may lead to dusty area.

3.3. Preparation room 36:

a. Office type grills.
b. Unsmooth surfaces due to Poor sealing of the wall partition.
MOH
c. Walls, floors & ceiling needed maintenance as some connections
were
not coved

4.1.
MOH
a. Ovens were in bad cleaning condition
MOH c. There was no SOP for good distribution of granules on trays.

MOH e. They were not considered in cleaning holding time study.

5.1.
a. Hoses used for collection of PW in coating solution room had
MOH no code
and no sop for cleaning them.

MOH b. Coating solution prepared at the same coating room 31.

a. Was humidity controlled less than 30% RH without justification

as
MOH hard gelatin capsules RH % limit 45-60

MOH b. Process was semi manual

MOH c. There was no vacuum with air blowing machine & it was not covered

MOH d. RH % was out of limit & no action taken

MOH a. There was no MAL for veterinary area

 8.1. Metal Detector:
a. There was no blank standard disk neither for challenge tests of
one
of the metal detectors in routine working nor in its qualification.
MOH
b. There was no certificate for the blank for anther detector has
blank
disk.

MOH 8.2. Batch record was missing metal detector step.

8.3. Label of intermediate going to be compressed was not

MOH clarifying period of
storage in staging area & its due date.

8.4. There was no SOP for transferring & handling of city water &
MOH PW used in
manufacturing area from washing area.

8.5. label of intermediate compressed tablets was not clarifying

MOH quantity units
e.g. tablets , capsules ....etc.

8.6. SOP for staging area operation was not clarifying steps of
MOH intermediate e.g.
milling, before compression.....etc.

8.7. Staging areas were deficient in:

a. Not organized at all which may lead to crowdness & mix up.
b. They were used for staging of different manufactured steps
e.g. after milling, after mixing, quarantine, released, .........etc.
MOH
without physical separation or allocation system for each step to
avoid mix up. e.g. room no. 165
c. There was no thermal mapping performed.

MOH 8.8. Feeding of powder was dusty manual feeding for most equipment.
MOH 9. Dry Powder Fill Bottles

10.1. Steroids
a. There was no risk study approach or appropriate cleaning
MOH
validation for manufacturing of steroids cream & liquids

MOH

MOH b. There was no appropriate SOP for handling steroids.

MOH c. There was no waste treatment.

d. Steroids with small concentration were not proven by the

company
to be non-potent steroid (as e.g. triamcinolone Acetonide steroids
MOH
in semisolid, also dexamethasone sod phosphate in liquid line)
while it had detectable limit established by the company by
calculation of acceptable residual limit ARL.
 10.2. MAL of semisolid preparation room was not sink or bubble
MOH although
steroids were included.

MOH 10.3. OEL was not calculated.

10.4. There was no schematic diagram for exhaust units used for
MOH all lines
which hinder reviewing of its design & qualification.

MOH 10.5. There was no safe bag-In-bag-Out housing for HEPA filters

11.1. There was no risk study approach for manufacturing of Oral,

nasal, ear
MOH & topical drops lines all in one area. (The same filling machine for
all
types).
 11.2. Microbial count was not assured:
a. Screw of filtration housing covered with contaminated industrial
oil
moreover was not covered (liquid)
b. Some tanks have no vent filter.
MOH c. All vent filters were 1 micro although the area was class D.
d. Feeding was manual.
e. Common class D washing area used for all dosage form.
f. Suppository machine filling part was not under LAF although
area was
class D.

MOH

MOH

MOH

MOH

11.3. Bottles were exposed to class D area after air blowing which
MOH could be a
risk of recontamination.
 11.4. There was more than one activity were done in the same
room without
any written instruction for separation in time.
& tank preparation machine, stirrer Ex. same the in room same the
MOH
in
tank storage or up mix of source a be could which time
contamination
cross.
MOH 11.5. Flow rate of solution filtration was not determined, recorded or validated.

MOH 11.6. Bottles blowing & filling was done in the same room.

11.7. Suppository preparation room was used as a pathway to

MOH
filling room.

12.1. Walls, floors and ceilings not smooth and contain cracks and
MOH open joints
ex.: control cabinet, hoses storage area.
MOH 12.2. Agitators of tank l, 2 not calibrated.

MOH 12.3. Major and minor cleaning was missed in logbook

(form/p/SYR/0/040/F02).
12.4. No double check for temperature, humidity and differential
MOH pressure in
form no (P/SOD/0/088/F02), (P/SOD/0/087/F06).
MOH 12.5. Doors of semisolid area were not well fitted

MOH 12.6. Gowning instructions was missed.

12.7. A ball valve has the disadvantage of being not easily

MOH cleanable found in
Diesel tank.
MOH 12.8. Timer of Diesel tank was not calibrated.

13.1. Visual inspection operator's qualification was not done

appropriately, not
MOH documented & not done on different challenges sets with different
defect
kits.

13.2. Manual challenge test did not cover color of tablet, type of
MOH tablet and any
defect in tablet challenge test was only for check empty blister.

13.3. Holding time for bulk product was not stated in label or
MOH batch record in
stage area room no 102 & 160.

13.4. There was uncovered part after polishing in blistering

MOH machine Ulhmann
BEC 300.
 13.5. Not all camera specifications on blistering line were
MOH challenged e.g. color
or broken tablets were not challenged only empty tablets

1.1. SOP receiving and handling of materials was inappropriate as

it didn't:
a. Mention the policy or system for using "Sampled" label.
MOH b. Mention checking and handling of the data loggers records for
transfer
& transport of Materials.

1.2. SOP of finished product release and SOP for transport of

released finished
product to the released finished products warehouse have
contradicting
instructions. E.g.: One of them strictly instruct release status and
MOH
transport
to the Released products warehouse performed after QA release
not QC
release and the other mentions transfer after QC release without
mentioning or waiting QA release.

1.3. Improper allocation system. i.e. By challenging the computer

allocation
system and comparing the location of some materials with their
actual
location in the warehouse some were not placed in the same place
MOH
as
mentioned by the computer system. E.g.: Oxytetracycline HCl
location
according to ERP system: Al 6/4 actually stored in another
location.

1.4. Quarantine raw material, Quarantine packaging material &

MOH Quarantine
printed packaging material were not stored in secured place.

MOH 1.5. It was not restricted to authorized person

1.6.There was neither SOP nor record for cleaning; maintenance &
operation
MOH
for dust collector (vacuum in place) also
dust collector without identified code.
MOH 1.7. Some raw material found in warehouse without vendor lot number ex

2.1. a. There was no allocation for the items stored in the Cold
MOH
Store.
b. There was no sufficient storage space in the cold store and
MOH pallets were
stored in an inaccessible way blocking means of egress.
MOH c. There was no physical separation between quarantine & released RM

MOH 3.1. There was no allocation for the items stored in the Flammable store.

3.2. There was no sufficient storage space for the Flammable store
MOH and pallets
were stored in an inaccessible way blocking means of egress.

MOH 3.3. Wooden Pallets used in the flammable store.

3.4. Flammable materials stored above each other & they were
MOH not off the
floor.

3.5. Records for temperature, pressure and humidity were stored

MOH in place in the
flammable store.

3.6. There was no physical separation between quarantine &

MOH release flammable
material.

MOH 3.7. There was no appropriate ventilation & temperature was not controlled.

MOH 3.8. Electric supply was inside the store without any safety precaution.

3.9. RH reach 60% without action taken also there was no specific
MOH conditions
for storage of flammable materials.

MOH 3.10. Absence of thermal mapping.

MOH 4.1.There was no ventilation system in return goods area.

MOH 4.2.There were neither SOPs nor records for daily check on temp & RH.

MOH 4.3.There were neither SOPs nor records for cleaning of return goods area.
 4.4.There was neither list of return goods nor reason of finish
MOH
product return.

MOH 5.1. There was no sufficient area for reject finish product and
expiry finish product & they were stored in street
6.1. Prepared detergent & disinfectant had neither quality control
MOH
no. nor batch no.
MOH 6.2. Supply grill in sampling room was not identified.

MOH 6.3. record of temp & RH in sampling room did not mention code
number of data logger.

6.4. There was no alert & action limit for daily environmental
MOH
records Ex temperature, RH & differential pressure.

MOH 6.5. There were no records for ΔP of LAF unit.

MOH 6.6. There was no alert & action limit for ΔP of LAF unit.

6.7. Balance in sampling room code C/RM/0/005 were deficient in

the following:
a.record of balance sheet was not including B.N. of raw material
MOH orrequest no.
b.Standard weight of balance was not in place.
c.Cleaning of balance record was not including pervious raw
materialsampling

MOH 6.8. SOPs of handling unclean tools were not in place.

6.9. Sodium Lamp in sampling room is deficient in the following:

a. There was no intensity check.
MOH B. There was no Logbook.
c. There was no Cleaning Logbook.
d. There was no identified code.

6.10. There was neither sop nor record for cleaning; maintenance
MOH & operation for dust collector (vacuum in place) used for cleaning
also dust collector was without identified code.

7.1. Sampling & dispensing room pressure were cascading to

MOH
outside.

MOH

7.2. There was no pressure gauge to monitor differential pressure

MOH at the dispensing washing room.
7.3. Dispensing washing room and the airlock before it were not
MOH identified by
name.
 MOH 7.4. Same entrance & staging for weighing room 1 & washing
room 2.

7.5. SOPs P/DSP/0/012 did not consider maximum holding time of

MOH
cleaned & dirty tools.
7.6. There was no gauge for monitoring ΔP between PAL of
MOH
dispensing & stage area of dispensing raw material.

7.7. Weighing room I there was no filter on compressed air use

MOH
point at liquid pump & this pump was without identified code.

7.8. Record sheet of weighing both codes no P/DSP/005/F02 did

MOH
not include acceptance limit of temp & RH.

MOH 7.9. Some clean tools were stored in washing bay room

7.10. There was no monitoring for differential pressure (no

MOH pressure gauge) between room no. 71 which used for storage of
clean polyethylene bags used in weighing & washing bay room.

MOH 8.1. Alarms were not implemented.

MOH 8.2. There was no protocol for cold room qualification
MOH 8.3. There was no site survey.
MOH 8.4. Locations of air flow were not illustrated.
MOH 8.5. There was no description of loads.
1.1. The attached forms to the SOP "Investigating out of
MOH specification test result in IPCQ section" were not updated to the
current version.
1.2. The attached form (FN C/RM/0/029/Fl0) to the SOP for
MOH
Training (C/RM/0/029) was not applied.

2.1. In finished product lab, safety procedure was not drawn up

MOH on storage of flammable and toxic liquids. (methanol, ethanol &
chloroform were stored in the same locker).

3.1. In raw material lab the note book of particle size analyzer (SN.
MOH 622921) amoxicillin 3H20 was documented in date 11/7/2017
evidence that this test was performed in lab

3.2. Balances were not installed on separate bench e.g.: (GR-200

MOH in raw material lab, Radwag, Mettler Toledo in IPC lab, Kern in
finished product lab & Kern in packaging lab)
 3.3. No printers were attached to balances (e.g.: GR-200 in raw
material lab & Denver in packaging lab), pH meters (e.g.: pH meter
MOH Inolab WTW pH 720 in IPC lab & Jenway (3510, 3320) in finished
product lab) and Conductivity meter (Jenway 4310 in IPC lab).

3.4. Sulphanilamide used for intermediate check of Melting point

MOH
M5000in raw material lab was not found.

4.1. A separate SOP for sampling hazardous raw material had to

MOH be issued to describe in details safety instructions for handling
hazardous materials.

4.2. In the SOP for sampling procedure in IPQC & raw material lab
MOH no procedure for safe handling and transfer of sampling tools from
sampling area for washing was stated.
 4.3. In the analysis of Tilmicosin phosphate (BN TMPZ1903074)
raw material:
a. No approved written procedure (SOP) was found for the
physical andchemical analysis including the details for each test,
MOH the acceptancecriteria and the reference used.
b. No method validation was found for the assay & related
compoundmethod.
c. No verified and approved work sheet was found for the assay.

4.4. In the analysis of Tilmicosin phosphate in Timosin® solution

(BN 4577Done000234):
a. The calculation of was differently conducted in assay
(calculation wasdone on the major peak) and in method validation
(calculation wasmade on the sum of the two peaks). Besides, the
MOH equation used forcalculation was differently documented in assay
method and in methodvalidation.
b. All data on the column used in the analysis of Tilmicosin
phosphate inTimosin® solution was completely erased.
c.The specification for volume in was taken as ± the labeled
volume andnot as NLT the labeled volume
 4.5. Method validation of the analytical method of Tilmicosin
phosphate analysis in Timosin® solution: DoneResolution was not
MOH
calculated in system suitability Done Photo degradation was not
conducted.

4.6. In the SOP for sampling procedure in raw material lab type of
MOH container was not mentioned.
4.7. The SOP for water analysis was upDonedated to the current
MOH
edition of the relevant pharmacopeia
4.8. No receiving log book was found for water samples, so water
MOH
samples were not easily tracked.

5.1. In raw material lab waste bottles (e.g. acid waste) was
MOH observed stored beside hotplate in the fuming hood, staff was not
aware enough for safety instructions for working in lab.

6.1.Disposal of contaminated wastes

MOH Disposal of microbiological waste materials and media containing
pathogenic materials is not done by autoclaving before being
discarded by the technician that can be harmful for him
 Pressure be added for all areas in layout Engineering 12/2020
Personnel flow - IN & Personnel flow – out
Engineering 12/2020
will be completed

Cupboard doors codes will be removed

Engineering 08/2020
from layouts

All Layouts will be revised and completed Engineering 12/2020

Coding system will be revised to unify

Engineering 12/2020
the codes
Risk Assessment will handle the required
Design/QA 06/2021
modifications to the area
PALs and MALs will be identifies Engineering 12/2020

Room names will be revised and identified. Engineering 12/2020

Waste flow will be illustrated on layouts Engineering 12/2020

Current classification will be illustrated
Engineering 12/2020
on layouts

SOP# P/OP/004 and P/DSP/O/007 will be

Production 06/2021
updated to include all the requirement

SOP# P/SOD/O/062 will be updated to

include transferring and feeding of bulk 06/2021
and intermediate to machine
 SOP# P/SOD/O/103 will be updated to
include the Proper handling, transfer &
Production 08/2020
storage of unclean and clean tools
after washing

SOP# P/SOD/O/103 will be updated to

Production 08/2020
include the transferring of water from use points

Each room has related SOP which cover all

activity including operation and cleaning Production
Ex: SOP# P/SOD/O/059,
P/SOD/O/009 & P/SOD/O/002

SOP# EHS/O/005 cover all requirements

of waste disposal. Production

Gowning Instructions are specified in

SOP# P/SEMI/O/014 for primary and Production
SOP# P/SOD/O/097 for Secondary Gowning
 Detailed instructions of cleaning in place
of machine is included in the respective
Production
machine SOP# P/SEMI/O/002,
P/SOD/O/010 & P/SOD/O/121

SOP# P/SOD/O/099 will be updated to

include the internal labeling, quarantine Production 08/2021
and storage of materials

SOP# P/SYP/O/023, P/SYP/O/027&

P/SOD/O/108 will be updated to include Production 08/2020
the required instructions

1-SOP# P/SOD/O/015 will be updatedto

include the required.
2-New SOP will be initiated to include Production 08/2021
qualification of visual inspection
Personnel.

QA Doc.
The number of AHUs will be added to SMF. 09/2020
Engineering
The BMS used will be added to SMF as
QA Doc. 09/2020
one of the validated computer systems.
The P&ID for the water station will be QA Doc.
attached to SMF. Engineering 09/2020

Expiry date has been recorded in raw

Production
material labels which attached in the BMR.

QA Doc.
The calculation to compensate the assay of R&D
01/2021
the API will be conducted. IT
Production

QA Doc.
The cleaning label will be attached to
QA Compliance. 01/2021
the batch record.
Production.
 The batch record will be updated to QA Doc.
include the recording of the ΔP, RH%, & Temperature of the QA Compliance. 01/2021
room before starting the processes. Production.

The BPR will be updated to include QA Doc.

attached blister sample and space for signature of the QA Compliance. 01/2021
authorized person. Production.

QA Doc.
The challenge test for metal detector
QA Compliance. 01/2021
will be recorded in the updated batch record.
Production.

Update SOP of preventive maintenance to

Engineering 12/2020
include wall, ceiling and floors.

Moisture Sensitivity & Photosensitivity QA

11/2020
will be added to subsequent studies Validation

Planned to be implemented as follows:

1-Effervescence Powder QA 11/2020
2-Liquid Validation 04/2021
3-Suppository 08/2021

Train Batches will be added in all QA

11/2020
upcoming Holding Time Studies. Validation

all upcoming protocols will

1-Stability Study will be specified as(Long-term) QA
2-Number of batches will be specifiedas (1 batch for the Validation 11/2020
study).

SOP# A/O/020 will be updated to include QA

08/2020
all the requirements Batch Release
 -Modify the check list
record to comply with BMS qualification. Engineering 10/2020
-Internal serialization will be Initiated.
-Production and Engineering to match their values
according to qualification

Items (a), (b), (c) and (e) are included in

protocol (GT/PH/PQ/P/BMS -02) IT Done

Item (d) will be added to the Qualification 12/2021

report
 SOP# A/O/005 will be updated to include
-Suppliers of disposable scopes
QA
-Reagents, media and external servicessuppliers 12/2020
Compliance
-Update the evaluation criteria
-Detail the disqualification andrequalification criteria

A new version of SOP environmental

control test NO. C/MIC/O/088 will be
QC 08/2020
issued , monitoring of main surfaces and
main production corridor is added

Air volume balance calculations will be

Engineering 03/2021
added in next Qualification

Air flow direction test will be added in

Engineering 03/2021
next Qualification
To be corrected in next Qualification Engineering 03/2021

Schematic Diagram will be added in next

Engineering 03/2021
Qualification

Will be revised & studied in next

Engineering 03/2021
Qualification

Risk Assessment will manage the Particles Engineering 03/2021

count test location
 Risk Assessment will manage qualification
Engineering 03/2021
requirement

Dehumidifier will be included in next Engineering 03/2021

Qualification

Dust collectors will be included in next

Engineering 10/2021
Qualification
Air shower will be included in next Engineering 03/2021
Qualification

Particle Size analysis will be done Engineering 03/2021

Samples and tests for Before and after

Engineering 03/2021
sand filter& micro filter will be added

Study will be performed to assess Engineering 07/2021

the degassing and NaOH addition

Install of temperature sensors for tank &

Engineering 03/2021
loop & Study for check temp. For all use point
Flow meter with alarm will be installed Engineering 03/2021
and validated
Study to Check spray ball Efficiency will be
Engineering 05/2021
validated
Validated and Certified UV lambs will be
Engineering 10/2020
installed
Study To Check sanitization Frequency &
Engineering 03/2021
validation will be done

SOP#C/RM/O/037 will be updated to

comply with the specification QC 12/2020

Study To Check sanitization Frequency &

validation will be done Engineering 03/2021

Addition of alarm system and include the

Engineering 10/2020
check in SOP# E/WTPII/O/008

Planned to be implemented as follows:

01/2021
1-Powder Filling machine, Blisteringmachine, Inspection QA
Camera & MetalDetector Validation
03/2021
2-Dust Collector

a .Risk-based Revalidation SchedulePlan for all equipment QA

will beprepared & its recommendations willbe added in 03/2021
Validation
VMP 2021 (PQAppendix)
 b. 3 products were considered in thestudy with variable
settings for CPPslimits, which were produced
&implemented at different schedule.To study impact of all Done
working rangelimits of Glatt Fluidized Bed DryerCritical
Process Parameters onresultant intermediates,

Schematic diagram or photos to

illustrate load & data logger distribution Engineering Done
will be added

Filter 0.2µm will be installed Engineering 12/2020

Alarm & sampling locations will be

Engineering Done
considered during next qualification

Qualification will be done to cover the

Engineering 06/2021
required critical parameters

SOP# A/0/055 will be updated to

include the requested items.
a. Detailed objectives ex.: process
QA
capability. 12/2020
Validation
b. Revalidation schedule plan.
c. Type of program used for statistical
study

a. Comparison study for two types of

coating machines will be performed
separately.

b. List of machines will be added in

subsequent studies.
c. Risk study for equipment will be QA
03/2021
performed separately Validation
d. CPK and CP will be added for P.V. SOP
& calculated in all upcoming studies.
e. Justification will be added in subsequent
studies & revalidation cycles.
f. Statistical study will be calculated for all
upcoming studies.
a. Justification for out of control will be
added in subsequent studies. QA
01/2021
b. Temperature and humidity Will be Validation
recorded for all upcoming studies.

All requirements will be added in all QA

01/2021
subsequent studies Validation

Risk-based Revalidation Schedule Plan

for all manufacturing lines will be QA 12/2021
prepared & its recommendations will be Validation
added in VMP 2021 (CV Appendix).
 All requirements will be added in all
subsequent studies & Revalidation QA
08/2021
cycles. Validation

Personnel and analytical method Will QA

be added in preparing VMP 2021. Validation 03/2021

a. A comparison exists at the end of the

second study (A02-VP003-2018) at QA
Done
page 19 of 19. Validation

SOP# A/O/006 will be updated to QA

08/2020
include the required notification Compliance
 a. SOP# A/O/019 will be updated to
include the required modifications b. Due to the
unique nature of the
largest recall (more than 78,000,000
units)
c. SOP# A/O/019 will be updated to
include separation between Critical
and Major Cases
d. SOP# A/O/019 will be updated to QA
include notification of Customers Compliance 08/2020
Supplied directly via Media
Notification

SOP# A/O/002 will be updated to QA 09/2020

include the required details Compliance

New SOP will be initiated to include

qualification of visual inspection Production 08/2021
Personnel

Risk Assessment will manage all the

QA
control measure for using single 06/2021
Compliance
corridor

Areas will be updated to include MAL

Engineering 08/2021
and PAL for all areas

Risk Assessment will manage all the QA

control measure for using single Compliance 06/2021
corridor

All doors have Auto Closures machines.

A challenge test study has been done for
Engineering Done
all doors
 Sound alarm will be added according
to risk assessment study. Engineering 06/2021
- Sound system will be included in
qualification program

Light sources for all rooms have been

maintained probably.
Engineering
- Preventive maintenance for facility
premises shall be followed strictly.

All doors and Auto Closures have been Engineering

fitted properly

A comprehensive revision have been

done for all differential Pressure gauges Engineering
, and recalibrate if necessary

Areas will be updated to include MAL

Engineering 08/2021
and PAL for all areas

a. Study will be performed to set the filter change system Engineering 06/2021

b. Monitoring will be added to SOP#

E/WTPIІ/O/008 10/2020

c. Risk Assessment Study will be made 07/2021

d. temperature sensor will be installed 09/2020

e. Acceptance limit will be added to

SOP# E/WTPIІ /O/008 10/2020
 f. Monitoring will be added to SOP #
10/2020
E/WTPIІ /O/008

Diaphragm Valve will be used Engineering 03/2021

Rearrangement for Pretreatment to

install softeners after Carbon filter will Engineering 01/2021
be done

A study of initial pressure drop shall be

Engineering 03/2021
done

Component’s Identification labels will

Engineering 08/2020
be installed in each AHU

Procedures for changing the filters will

be added in the SOP Engineering 12/2020

Procedures for restarting will be

Engineering 03/2021
initiated

Fan Speed monitoring will be added to

Engineering 03/2021
respective SOPs

SOP will be initiated to cover

a. Records for cleaning
Engineering 03/2021
b. Records for monitoring
c. Records for maintenance

d. Schematic diagram will be added 03/2021

e. Calibration will be done 03/2021

 Recalibration to be performed Engineering 08/2020

Gauges will be connected between all

Engineering 03/2021
filters

SOP# P/SOD/O/089 will be updated to

include
1- the record of operation Production 09/2020
2- verification range to cover the entire
working range of the balance

Areas will be classified Engineering 03/2021

Doors will be properly maintained.

Done
Access Control will be installed Engineering
08/2021

SOP# E/CS/O/003 will be updated to

Engineering 03/2021
include the requirements

Risk Assessment will cover all the

Design 06/2021
required control measures

MAL and PAL with controlled

humidity separate between low
Design Done
humidity corridor and normal humidity
corridor

Steps will be considered in next QA 03/2021

studies. Validation
 SOP# P/SOD/O/062 will be updated to
Production 07/2021
include the requirements

Sink MAL and PAL is present for

Liquid areas
Done
MAL and PAL will be added during Design
12/2021
semisolid area upgrade proposal to the
IDA

SOP# P/SEMI/O/014 will be updated to

Production 08/2020
include the requirements

Primary Gowning area will be upgraded Design 12/2021

Ceiling has been sealed and maintained

Engineering
properly

To be maintained properly Engineering 12/2020

SOP# P/SEMI/O/014 will be updated to

include separation between indoor and Production 08/2020
outdoor gowns

New calibrated pressure gauges shall be

installed and monitored to cover all
Engineering 12/2020
affected areas

a. Room will be illustrated on layout

b. To be substituted with a Cupboard Engineering 03/2021
with louvers

Update layout to include Airlock. Engineering 12/2020

All emergency doors have been

Engineering Done
maintained
 New vacuum machine will be added to
the area so that all water and powder
Production 09/2020
vacuum m/c are dedicated to
preparation areas

Access control well be added to all Engineering 06/2021

production areas entry points
Delta p monitoring gauge will be
installed. will be included in daily Engineering 10/2020
checkup.
All Log Sheets will be bounded Production 08/2021

1- Logbook for operation and cleaning Production

08/2020
will be added for each sodium lamb Done Engineering

2- Lamb will be calibrated and intensity 06/2021

checked routinely
Test is done as an IPQC test in the lab
QA Done
during process for all bottles

1- As per TRS 961 annex 6 common

washing bay of class D is accepted to
handle components for all area class
2- As per SOP# P/SOD/O/109 only
cleaning and drying step is done in Design Done
the washing bay, while the
disinfection step is done at the
processing room under the same
classification

Clean airlock has been modified to be

Engineering Done
bubble

SOP# P/SOD/O/104 will be updated to

Production 08/2020
include the addition of disinfectant

Water collection ducts will be slopping

Engineering 06/2021
towards the drain
 SOP# P/SOD/104 will be updated to
include check on drains cleaning and Engineering 08/2020
drainage

Area will be upgraded. Engineering 03/2021

Requalify and improve the dust
Engineering 03/2021
collector efficiency

The grill has been replaced by a

perforated type grill. Engineering Done
The wall partition has been maintained.

1- (a) and (g) Incident report is created,

3- SOP# P/SOD/O/066 willwas
be updated QA Done
recleaning and retraining done
to include
2- (e)Covering
-(b) Will be added in a separate
and Labeling of study. Production 09/2021
Trays after Cleaning
QA
- (c) Distribution of Granules 07/2021
Validation
- (d) Drying Period before
Loading of Granules
- (f) Transfer of Clean Trays
- (h) Challenge SOP# P/OP/014
at max temp will be updated to
include the requirements Production 08/2020

Area has been updated to make a

Design Done
solution preparation room

Risk assessment study will determine

the best suitable limits Design 06/2021

All process critical parameters and

attributes are identified and qualified as Engineering Done
per Report # QA/VQ/R/PQ/043.01
Air blowing machine will be supplied
Engineering 03/2021
with vacuum and cover
Incident was initiated and room was not
Production Done
in operations at the time of visit

A new veterinary area will be installed

Design 09/2022
to comply with all the required points
 A certified blank standards will be
requested and the mentioned device will Engineering 08/2021
be requalified

QA Doc.
The challenge test for metal detector
QA
will be recorded in the updated batch 01/2021
Compliance.
record.
Production

SOP# P/SOD/O/062 will be updated to

add the storage period and Hold Time Production 07/2021
Due Date

SOP# P/SOD/O/103 will be updated to

include the transferring & handling of Production 08/2020
city water & PW

SOP# P/SOD/O/099 will be updated to

include the identification of quantity
units Production 08/2021

SOP# P/SOD/O/062 will be updated to

include clarification of steps of Production 07/2021
intermediate

a. Staging areas will be organized 08/2021

b. Staging areas will be separated into
identified areas for different product 07/2021
Production
statuses and will be included in the
SOP# P/SOD/O/062
c. Thermal mapping will be done
12/2021

Dust collector will be provided for all

required areas Engineering 03/2021
A new dry powder filling area will be
installed to comply with all the required Engineering 04/2022
points

For Creams Line; Risk Approach was

made to select the worst case product on
line (Farcomethacin Gel) & already
performed as per CVR# 007, also QA
Done
Cleaning Validation for the steroid Validation
product (Topicort Cream –
Triamcinolone Acetonide) was
performed according to CVR# 006

For Liquid line; Cleaning Validation

was performed for steroid product
(Dexaphen Syrup – Dexamethasone) as
per CVR# 008, also cleaning validation 04/2021
study will be implemented for the worst
case product (Non-steroid) selected as
per Risk Assessment for line products.

SOP# P/OP/002 specified the

instructions for the handing of steroids
including detailed instruction for
Production Done
dispensing, preparation for both lines
and the respective cleaning
requirements

Waste treatment for all hazardous

substances is done as per national HSE Done
regulation in SOP# EHS/O/005
Steroids with small concentration
(Dexamethasone Sodium Phosphate in
Liquid line & Triamcinolone Acetonide
in Semi-solid line) were proven to be
non-potent & have no pharmacological
action on subsequent products by
calculating ARL for the 2 of them in a QA
Done
specific CV protocol for each (CVP# Validation
006 & CVP# 008) & Implementing
these 2 studies for 3 successive runs for
each, where all results were conforming
the specifications (ARL) for the 3 runs
at each study as per Reports # (CVR#
006 & CVR# 008).
The proposed layout will be submitted
to the IDA and implementation will Design 06/2021
start after IDA approval

OEL is defined for each material

separately in respective material safety
EHS Done
data sheet MSDS

Schematic diagram for all exhaust

Engineering 12/2020
units will be completed

Safe procedure for replacing HEPA

Engineering 06/2021
filters will be implemented

QA
Risk Assessment will be done 06/2021
Compliance
a. Incident was created and housing
Design Done
was re-cleaned and disinfected

b. Vent filters will be installed 06/2021

d. Due to small quantities of powder

raw material which would make Done
automatic feeding impossible

e. As per TRS 961 Annex 6

components intended for sterile
processing is required to be handled
after washing in at least grade D Done
Disinfection Step is done at the
processing location in the same area
class

f. The proposed layout will be

submitted to the IDA and 06/2021
implementation will start after IDA
approval

Area between air blowing step and

Design 08/202
filling step will be covered
 SOP# P/OP/001 Will be updated to
state that no more than one activity is
Production 08/2020
allowed to be performed in the same
room at the same time

Flow rate will be determined and

Engineering 06/2021
qualified
Air Blowing machine is covered as Design Done
required in action 9.1

The proposed layout will be submitted

to the IDA and implementation will Design 06/2021
start after IDA approval

Walls, floors and ceilings will be

Engineering 10/2020
maintained properly

Agitators of tank l, 2 to be calibrated Engineering 03/2021

SOP# P/SYR/0/040 will be updated to Production 08/2020
include the requirements

Double check has been added by QA Production Done

Compliance personnel

Doors have been properly maintained Engineering Done

Gowning Instructions are specified in Production Done
SOP# P/SEMI/O/014

Ball valve will be changed to

Engineering 01/2021
Diaphragm or butterfly valve

Timer of Diesel tank will be calibrated Engineering 08/2020

New SOP will be initiated to include

qualification of visual inspection Production 08/2021
Personnel

SOP# P/SOD/O/095 will be updated to

include challenge test for all defects Production 07/2021

Refer to Point # 8.2 for recording of the

Production Done
Hold Time

This part will be covered Engineering 08/2020

SOP# P/SOD/O/095 will be updated to
Production 07/2021
include challenge test for all defects

SOP# W/O/001 will be updated to

include:
1- reference to SOP# C/RM/O/032
which handle the use of Sampled
Label Warehouse 08/2020
2- handling of data loggers used during
transportation

SOP# S/O/002 will be updated to

specify the transport will be after QA Warehouse 08/2020
release only

Incident report was created

a- Retraining with for store keeper
was done on SOP# W/O/002
b- SOP# W/O/002 will be updated to QA
08/2020
include Compliance
1- Monthly inventory for all products
2- Challenge test for inventory control
every week

All storage corridors will be fitted with

secure gates with access control Warehouse 08/2020

All warehouse entry points will be fitted

Warehouse 06/2021
with access control devices

SOP# W/O/001 and W/O/002 will be

updated to include m/c code and
Warehouse 08/2020
operation, cleaning and maintenance
logbook
 Incident report was created
1- Retraining of receiving personnel
was done Warehouse 08/2020
2- CAPA from supplier to assure
conformance with required labeling

Allocation System will be added to cold

Warehouse Done
store

Area will be arranged to ease the

Engineering Done
storage

Area will be separated and identified Warehouse 12/2020

Allocation System will be added to of
Flammable Store Warehouse 08/2020

Area will be arranged to improve the

storage capacity Design 08/2020

Wooden pallets will be replace with St.

Warehouse 12/2020
St. pallets

St. Pallet will be used for the

Design 12/2020
elevated storage

All records will be stored securely Warehouse 08/2020

outside the store door

Area will be separated and identified Warehouse 08/2020

Risk # 004/2017 was Issued to address

the problem and concluded with Design Done
conforming to the requirement with the
“National Fire Protection Association”

All electric supply is certified as

explosion proof EHS Done

SOP# W/OP/005 will be updated to

include specification for storage Warehouse 08/2020
conditions
QA
Thermal mapping will be performed 12/2020
Validation
New Area will be updated Design 12/2020
SOP# W/OP/005 will be updated to include the
requirements Warehouse 08/2020

SOP# W/OP/004 will be updated to include the

Warehouse 08/2020
requirements
Reject Stock was exceptionally high due to the following
1-MOHSOP#Changed its requirements
S/D/O/002 fordestruction
will be updated to includebythe
pressure "‫ "اــلدهس‬todestruction by fire which lead todelay of Warehouse 08/2020
requirements
all destruction operations foralmost 6 months and
accumulation ofmore than 500 reject pallets Warehouse Done
2-MOH unprecedented request of thelargest voluntary
recall of allproduced 7000+ Rani Eff. Granulesbatches over
Addition78,000,000Box)
(almost of Detergent/disinfectant preparation form in SOP
QC 08/2020
All pending reject palletsC/RM/O/024
have been disposed of and
destructed. Supply Grills will be identified Engineering Done

Addition of Hygrometer code No. in Form C/RM/O/030/F02 QC 08/2020

Addition of alert limits in C/RM/O/030/F02 QC 08/2020

Addition of ΔP of LAF unit measuring form in SOP

C/RM/O/024 QC 08/2020

Addition of alert & action limits in SOP C/RM/O/024 QC 08/220

a-Addition of Request No. in operationform

b-Addition of statement that Standardweights are in the lab
and aretransferred to the sampling roomduring balance
QC 08/2020
check
c-Addition of previous sampled rawmaterial in maintenance
form

Distributed copy for SOP C/RM/O/044 is placed in sampling

QC 08/2020
room

a-Intensity Check will be done QC 06/2021

b-Addition of sodium lamp use inSOP# C/RM/O/024 08/2020

Addition of operation & cleaning form for dust collector QC 08/2020

giving it an identified code in SOP C/RM/O/030

Dispensing Rooms corridor is bubble to connected A/L and

Engineering Done
weighing rooms
Sampling room pressure differential will be modified to be
12/2020
bubble
pressure gauge will be installed to monitor differential
pressure Engineering 12/2020

Labels will be added to the doors Production 08/2020

 Entrance corridor is positive pressure on both weighing
rooms Design Done
Materials are stored in locked identified cages in the staging
room

SOP# P/DSP/O/012 will be updated to include the

Production 05/2021
requirements

pressure gauge will be installed Engineering 12/2020

Connecting a 0.2μm filter to air supply and putting identified

Engineering 12/2020
code label on pump.

SOP will be updated to separate the Temp. and RH

Production 06/2021
recording and addition of limit in the new form

Tools are cleaned in washing machine which is a closed

Design Done
system which prevent possibility of contamination

Pressure gauge will be installed Engineering 03/2021

QA
Will be added in subsequent studies 10/2020
Validation
IQ, OQ and PQ are done as per qualification plan Done
Will be added in subsequent studies 10/2020
Will be specified in subsequent studies 10/2020
Will be added
SOP of OOS Version No.06 in subsequent
issued studies
08/10/2019 while the case 10/2020
of pharcovap ointment Batch No.120 was recorded in
20/01/2018 in forms QC Done
Version No.05 normally where at this date the version of
SOP is 05.
FN C/RM/0/029/Fl0 is already applied QC Done

A new cabinet intended for flammable chemicals will be

allocated separately from the cabinet that contains the rest QC 08/2020
This Situation is done of in the
the second shift, where, there was
chemicals.
penicillin facility lab sterilization. So, the analyst measure
the particle size of this batch which has been sampled
before, by taking the sample from the penicillin facility lab
before starting of sterilization process to general facility lab QC Done
depending on his personal wrong decision, Re-training on
GMP Requirements concerning this point is done & follow-
up was done to ensure effectiveness of training and this
situation hadn’t been repeated till now.

Balances will be installed on aspecific marble on a separate QC 08/2020

bench.
 On upgrading layout of QC Sectionsa separate weighing
08/2021
table will bedesigned.

Communication with Purchasing is done through official

mail to check the availability of a compatible printer. If “not
available” a purchase order with new apparatus to fulfill all QC 2/2020
data integrity requirements will be done.

Sulphanilamide st. has been supplied. QC Done

Dealing with hazardous materials is mentioned in SOP

C/RM/O/030 & staff must be aware & follow MSDS for each
material as guidance for safe handling according to SOP QC Done
EHS/O/020, C/RM/O/026.

For Raw Material: Done Handling & transfer of sampling

tools are mentioned in SOP C/RM/O/044 Item 8.2.8, that
“After sampling process the sampling tool is stored in QC Done
another polyethylene bag until the cleaning process
begins”.
For IPC the statement for transferring sampling tools will be
added in SOP C/INP/O/029. 08/2020

a-Already there is approved method forthe Tilmicosin

phosphate with codeRM272/120/53 where physical
andchemical analysis with its detail withits acceptance
criteria and thereference used & including numberof the QC Done
method of assay INS 2.10.13& a copy from specifications
isdistributed to central section.

b-QC requested the validation methodsfrom supplier 08/2020

c-the calculation attached is fullycomplete Done

a-The method of analysis of Assay oftilmicosin Phosphate

INS 1.3.81 willbe updated according to R&D validmethod QC
08/020

b-There is attached certificate forcolumn used for Timosin Done

analysisand all data found on it.
 c-The NODCAR for the product didnot include Average
volume & the ±is internal specification fromUltravet for
more improvement thevolume will be updated to NLT Done
1000ml & notification to Ultravet will besend to take into
consideration in re-registration

Resolution is added to the system suitability in the

R&D 10/2020
validation report (CCR will be issued).

Photo Stability Chamber will be purchased 12/2021

Addition of container type in Inspection report in SOP
C/RM/O/030 QC 08/202

SOP#C/RM/O/037 will be updated to comply with the

QC 12/2020
specification

Addition of receiving log book in SOP C/RM/O/037. QC 08/2020

Waste bottles is stored outside the fuming hood away from

QC Done
the hot plate.

Our system for disposal of microbiologicalwaste material

includes:
1-Qualified and well trained personwho wear all safety tools
duringhandling of microbiological waste,has GMP training
including handwash and disinfection
2-Separate washing room fitted withsuction fan and HVAC
system. QC Done
3-Separated, calibrated autoclave usedfor discarding only.
4-Disinfection program includingsporicidal and
bactericidaldisinfection.
5-Disposal of microbiological wastematerials is done then it
is sent to(Environmental Health and SafetyDepartment)
daily.
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