QAD-010 - Self Inspection

STANDARD OPERATING PROCEDURE
Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Revision No. 02 Supersedes 01
Department Quality Assurance Page No. 1 of 99
Effective Date Review Date
1.0 OBJECTIVE:
To lay down a procedure for self-inspection.
2.0 SCOPE:
This SOP is applicable for self-inspection to all departments to ensure that the systems are
adequate implemented effectively in Cospharm Pharmaceuticals Pvt Ltd.
3.0 RESPONSIBILITY:
Designation Responsibilities
Officer QA  Responsible for preparation of Self Inspection Planner,
Notification, Verification of CAPA and compliance of the
procedure mentioned in this SOP.
Head Auditee or his/her  Execution of self-inspection as per approved planner
designee  Timely Compliance of Non-Conformance Observed during
inspection
QA Pharmacist or his/her  Responsible for planning and execution of the self-inspection
designee as per approved planner.
 Training to self-inspection team members
 Closure of the CAPA
4.0 ACCOUNTABILITY:
QA Pharmacist and respective department Head
5.0 PROCEDURE:
5.1 Preparation & Distribution of Self Inspection Calendar:

5.1.1 There are two types of inspection that is the planned and unplanned inspection or
audit. The planned inspection also termed as self-inspection has a calendar referred
to in Annexure 1.An unplanned inspection can also be called Gemba Walk and this is
done randomly by the management or heads of department and it is recorded in the
Gemba Walk Observation Tracking Record referred to in Annexure-IX and the
Prepared By Checked By Approved By

Signature
Date
Designation QA Clerk Validations QA Pharmacist
Pharmacist
Department Quality Assurance Validations Quality Assurance
Format No.: COS/QAD/001/F01-01

responsible department with the identified observation is expected to fill the non-
conformance form referred to in Annexure X. The observations identified in the
inspection are noted down by the QA department and reviewed in the monthly
production meeting. Prior to the planned self-inspection, the inspector should review
the observations and include them on the checklist. At the start of every calendar
year Quality Assurance department shall prepare a self-inspection planner, which
shall be checked by department personnel and approved by QA Pharmacist as per
Annexure-I entitled “Self-Inspection Planner and execution record”.
5.1.2 After getting approval, control copy of self-inspection Planner and execution record
shall be issued to all departments for reference.
5.1.3 Each department & section must be inspected Twice in a Calendar Year±15 Days, in
case of product recall & critical market complaints and as on when required.
5.2 Selection of Self Inspection Team:

5.2.1 Team Members:
5.2.1.1 QA Pharmacist shall select a Self-Inspection Team based on Cross Functional
Departments at the Start of Every Calendar Year as shown in Annexure-VII, Titled “Self-
Inspection Team”.
5.2.1.2 The Selection of auditor in the self-inspection team shall be based on these qualities:
5.2.1.2.1 Must have appropriate range and depth of knowledge.
5.2.1.2.2 Must have Good observation power.
5.2.1.2.3 Must be an enquiring, yet open mind.
5.2.1.2.4 Must have ability to think.
5.2.1.2.5 Must be Articulate-Good Communication Skill.
5.2.1.2.6 Familiar with the cGMP.
5.2.2 Selection Criteria for Self-Inspection team Member:
5.2.2.1 Qualification (At least graduate)
5.2.2.2 Expertise
5.2.2.3 Technical Skills
5.2.2.4 Power of logical analysis.
5.2.2.5 Based on above criteria team leader, member & lead auditor shall be selected.
5.2.3 Team Description:
5.2.3.1 QA Pharmacist-Leader/His/her designee
5.2.3.2 QC Chemist-Team Member
5.2.3.3 Production Pharmacist-Team Member

Signature
Date
Pharmacist

5.2.3.4 Plant and validation engineer -Team Member

5.2.3.5 Stores-Team Member
5.2.3.6 Person from HR-Team member
5.3 Auditing Criteria:

5.3.1 Inspection team shall consist at least 2 cross functional department/section
personnel based on internal customer concept.
5.3.2 In absence of team member, deputy or representative of the department shall be
considered as team member.
5.3.3 Lead Auditor and Team members in the specific Self Inspection team shall not be of
auditee department, where the Self Inspection is planned.
5.3.4 QA audit shall be performed by internal auditor along with external qualified auditor.
5.4 Training of Self Inspection Members:

5.4.1 Before performing the Self Inspection, training shall be provided by QA Pharmacist or
his/her designee to all self-inspection team members or their deputies on all related
topics & shall be evaluated by written examination (through Questionnaire).
5.4.2 Training to all team members shall be given through self-inspection checklists.
5.4.3 Team members shall be qualified for self-inspection if they scored more than 80% marks
5.4.4 If the score mark is less than 80% then the team member shall be retrained on all
related topics & after re-training if a person fails to get 80% marks then it shall be
disqualified from the team.
5.5 Self-Inspection Planning & Execution:

5.5.1 QA Pharmacist or lead auditor shall inform the respective department at-least 3
working days prior to self-inspection through Annexure-VI entitled “Self-Inspection
notification & execution record”.
5.5.2 If proposed schedule is agreed by the auditee department, they shall fill the record with
sign on date & submitted to lead auditor.
5.5.3 In case of disagreement, auditee department shall propose the next scheduled date
within that month only, along with reason of rescheduling with Sign & Date.
5.5.4 In both cases i.e. agreed or disagreed (re-scheduling) lead auditor shall circulate
Annexure-VI between all team members to notify them about inspection.
5.5.5 Prior to start of the Self Inspection on the Planned Date, Auditors and Auditee (s) both
shall sign on the Self Inspection Planning and Execution Record.

Signature
Date
Pharmacist

5.5.6 The audit will commence with reference of cGMP norms, SOP’s, procedure work,
instruction, previous Inspection reports etc.
5.5.7 The auditor shall deeply examine the implementation and compliance of the cGMP
norms, last audit report, SOP’s, established system and procedures for any type of
deviations and recommendation. Self-Inspection shall be conducted as per respective
department/area checklist but not limited to.
5.5.8 After completion of Self Inspection, lead auditor shall fill the Execution Part of the Self
Inspection Planning and Execution Record and same shall be sign by Lead Auditor, team
member and lead auditee.
5.5.9 If any of the auditors is not present on the date of Self Inspection Execution, as per plan,
then his/her deputy shall act as team member.
5.5.10 If QA Pharmacist is not present on the date of self-inspection execution, as per plan and
his/her deputy shall act as a Lead auditor.
5.5.11 If any of the auditee is absent on the date of self-inspection then designee of the
auditee department shall put the remarks & sign with date on the self-inspection
Planning & Execution record subsequently as applicable in front of their name.
5.5.12 In case, Inspection is not completed in one day, it can be continued on next day or any
other agreed day.
5.5.13 During Self-Inspection, the Auditors shall check according to the checklist with
cover following below points but not limited to:
5.5.13.1 Personnel
5.5.13.2 Premises including Personnel Facilities
5.5.13.3 Maintenance of Building and Equipment
5.5.13.4 Storage of Raw Materials, Packing Material, Intermediates and Finished
products.
5.5.13.5 Equipment
5.5.13.6 Production and In-process control
5.5.13.7 Quality control
5.5.13.8 Documentation
5.5.13.9 Sanitation and Hygiene
5.5.13.10 Validation and Revalidation
5.5.13.11 Calibration of instrument or Measurement System
5.5.13.12 Recall Procedure
5.5.13.13 Complaints Management
5.5.13.14 Label Control

Signature
Date
Pharmacist

5.5.13.15 Transportation of Medicine And Intermediate

5.5.13.16 Waste Management
5.5.13.17 Results of Previous self-inspection and corrective step taken.
5.5.13.18 Gemba Walk Observations.
5.5.14 Self-inspection team members must have plan of how they are going to conduct self-
inspection.
5.5.15 Conduct the self-inspection by asking questions, observing records, documents etc.
5.5.16 Take following care while asking questions:
5.5.16.1 Question asked must be objective, specific and precise and require a specific answer.
5.5.16.2 Auditor must wait patiently for the response to their questions.
5.5.16.3 Auditor must be aim to be constructive and would avoid destructive or personnel
criticism.
5.5.16.4 Auditor must avoid any heated argument.
5.5.16.5 If auditors make a mistake, or misunderstand something, they must admit it, and
seek to understand better rather than cover up.
5.5.16.6 Auditor must try to stick on what they want to see rather than what auditee shows.
5.5.16.7 Auditor must give importance to the point that task of auditor is not limited to the
disclosure of faults, deficiencies and discrepancies.
5.5.16.8 The auditor must connect as observation with assistance in making necessary
improvements. Educational and motivational elements must be considered.
5.6 Self Inspection of Various departments shall be conducted as per respective checklist as
mentioned below but not limited to:
S. No. Department Name Section Checklist No.

1. Production Granulation SI/001/1.0
Tablets Compression SI/002/1.0
Coating SI/003/1.0
Capsule Section SI/004/1.0
Production Packing SI/005/1.0
2. Quality Control Chemical SI/006/1.0
Microbiology SI/007/1.0
3. Quality Assurance Documentation, IPQA, Validation and Qualification, SI/008/1.0
Quality management systems
4. HRA Human Resources & Administration SI/009/1.0

Signature
Date
Pharmacist

S. No. Department Name Section Checklist No.

5. Engineering Water System, HVAC, Utilities and Preventive SI/010/1.0
Maintenance
6. Warehouse Warehouse and Dispensing SI/011/1.0
7. IT Computerized System including Software used by SI/012/1.0
Stores, Engineering, Production, QA and QC
8. Production Liquids Mixing SI/013/1.0
5.6.1 Numbering System of Checklist:

For example: SI/001/1.0
SI= Self Inspection
001= Serial number in 3 numerical digits
1.0= Version No. of checklist. First Version shall be referred as 1.0 second 1.1….1.2…
onwards.
/ =Separator
5.6.2 Self-Inspection Checklist of all the Departments shall be available with the QA
Department and same shall be issued to the auditors during execution of Self
Inspection. QA Department shall assign the Audit Report Number to the Issued Checklist
as per the procedure mentioned below.
5.6.3 The Auditors shall refer the Self Inspection Checklist and record the observations in the
checklist. The scope of the Self Inspection is not limited to the Checklist only.
5.7 Audit Report Numbering System:

5.7.1 The Audit Report No. is consisting of an Twelve Alphanumerical characters as shown
below:
SI/XXX/18/01
Where,
“SI” denotes Self Inspection and “XXX” represents Department Code.
Department Code:
PRD Production
QCD Quality Control
QAD Quality Assurance
HCA Human Resources and Administration
ENG Engineering
SD Stores

Signature
Date
Pharmacist

ITD Information Technology

PVC Pharmacovigilance
“/” Denoted as Separator
“18” denotes Current Calendar Year
“01” denotes Serial Number for that individual dept. Suppose, in current year first time
inspection will be numbered as 01 & for second time as 02.
For Example, First Self Inspection Report of Quality assurance department for the Year
2018 shall be numbered as SI/QA/18/01 and followed by SI/QA/18/02.
5.7.2 The same Audit Report Number shall be assigned to Non-Conformance & Compliance
Report (if any).
5.7.3 The Non-Conformance observed during the Self Inspection shall be formally detailed
and discussed with the Auditee during Self Inspection closing meeting.
5.7.4 Discrepancies observed during Self Inspection are categorized as Critical, Major and
minor:
5.7.4.1 Critical: This directly affects the quality, safety and purity of product and not
Complying with GMP practice. Corrective action to be taken immediately. All Critical
non conformances should be closed off within 14 days of initiation or within the
tentative date mentioned in CAPA report. All critical unresolved non conformances
should be escalated to the Management Review meeting.
5.7.4.2 Major: This indirectly affects the quality, safety and purity of product and not
complying with GMP practice corrective action to be taken immediately. If a Major
nonconformance is repeated more than three times, it could turn into a critical
deviation, and must be treated as such. Major defects should be closed within 21
days of initiation or within the tentative date mentioned in CAPA report.
5.7.4.3 Minor: These are Defects, which can be noted and corrected at scheduled program
which do not affect the product quality attribute, a critical process parameter, or an
equipment or instrument critical for process or control. If a minor nonconformance is
repeated more than three times, it could turn into a major deviation, and must be
treated as such. All minor defects should be closed within 30 days or within the
tentative date
5.8 Preparation of Self Inspection & Compliance Report:

Signature
Date
Pharmacist

5.8.1 After completion of Self Inspection, QA Pharmacist/Lead Auditor or his/her designee

shall prepare Non-Conformance Report observed during Self Inspection by filling up
Annexure-IV entitled “Self-Inspection Non-Conformance & compliance report”.
5.8.2 Lead auditor & head auditee shall sign on the printed version of the report and QA shall
stamp this report as controlled copy.
5.8.3 Controlled copy shall be stored in QA department for future references.
5.8.4 Self-audit non-conformance & compliance report in word format shall send to Head
auditee department through mail for compliance within Seven Working Days.
5.8.5 Auditee Department shall prepare the Compliance Report along with Corrective and
Preventive Action (CAPA) Plan along-with the Targeted Date of Compliance on the
Report in word format and shall sign in the column of Head Auditee after CAPA agreed
by QA and shall submit to QA for filing. QA shall control this report.
5.8.6 CAPA report shall be submitted to QA Department within 15 Working Days from the
Date of Receipt of Report. The Date of Receipt of Compliance Report shall be recorded
in Self Inspection Record.
5.8.7 Auditee shall ensure that the agreed CAPA mentioned on the date shall be completed
within the given time frame.
5.8.8 QA Department shall verify the Compliance of agreed action plan on or last tentative
completion date mentioned in the report (Except lengthy targeted date of completion).
5.8.9 User department shall notify QA Pharmacist in case of deviation from the TCD.
5.8.10 QA Pharmacist shall discuss thoroughly with the auditee and grant permission for the
revised TCD when action could not be completed due to unforeseen event,
unavoidable circumstances or any other justified reason in format as shown in
Annexure-V.
5.8.11 If compliance verification by QA representative is found satisfactory and all the non-
conformances are closed by the Auditee Department, QA Pharmacist shall close the Self
Inspection Report.
5.8.12 Self inspection record shall be maintained by QA in format as shown in Annexure-II.
5.8.13 All the Closed Self Inspection Reports shall be stored in the Quality Assurance
Department for Next 14 Years.
5.8.14 Self-Inspections reports are confidential Records. Reports shall not be shown to any
outside person.
5.9 Self-Inspection Review and Trending:

Signature
Date
Pharmacist

5.9.1 Continue verification of self-inspection observation with implemented CAPA shall be

done on every 06 Months±15 Days for effectiveness.
5.9.2 Self-inspection review Report and trend shall be prepared in format as shown in
Annexure-VIII.
5.9.3 In case of any deficiency observed during review same shall be initiated through
CAPA system.
5.9.4 The effectiveness of observation arising from self-inspection CAPA shall be reviewed
as a part of “Management Review.
5.9.5 Summary of self-inspections shall be discussed by QA Pharmacist or his/her designee
in Management Review Meeting. QA Pharmacist shall ensure the implementation of
discussion taken in the management review meeting in relation to inspection points.
6.0 ANNEXURE:
Annexure No. Annexure Name Format No.
Annexure-I Self-Inspection Planning and Execution Record QAD/010/F01-01
Annexure-II Self-Inspection Record QAD/010/F02-01
Annexure-III Self-Inspection Checklist QAD/010/F03-00
Annexure-IV Self-Inspection Non-conformance & Compliance Report QAD/010/F04-00
Annexure-V Justification Form for Delay Self Inspection Compliance QAD/010/F05-00
Annexure-VI Self-Inspection Notification and Execution Record QAD/010/F06-00
Annexure-VII Self-Inspection Team QAD/010/F07-00
Annexure-VIII Self-Inspection review report and trend analysis QAD/010/F08-01
Annexure-IX Gemba Walk Observation Tracking Record QAD/010/F09-00
Annexure-X Gemba Walk Non-Conformance Form QAD/010/F10-00
7.0 SAFETY PRECAUTION:
Not Applicable
8.0 ABBREVIATIONS:
SOP : Standard Operating Procedure

G : General
HRA : Human Resources Administration

Signature
Date
Pharmacist

CGMP : Current Good Manufacturing practices

HVAC : Heat Ventilation Air Conditioner
IPQA : In-process Quality Assurance
IT : Information Technology
GMP : Good Manufacturing Practices
QA : Quality Assurance
No. : Number
CAPA : Corrective and Preventive Action
SI : Self Inspection
GM : General Manager
QC : Quality Control
TCD : Tentative completion date
9.0 SOP DISTRIBUTION:
S. No. Department Copy No. Controlled Copy (For office use)/Display Copy
1. Quality Assurance 01 Controlled Copy
2. Quality Control 02 Controlled Copy
3. Microbiology 03 Controlled Copy
4. Stores 04 Controlled Copy
5. Production 05 Controlled Copy
6. Engineering 06 Controlled Copy
7. HCA 07 Controlled Copy
8. IT 08 Controlled Copy
9. RA 09 Controlled Copy
10. RDTT 10 Controlled Copy
10.0 CROSS REFERENCE SOP (S):
S. No. Cross reference SOP No.

1. COS/QAD/012
11.0 CHANGE HISTORY:

Signature
Date
Pharmacist

Revision Effective Details of Change Reason For

No. Date Revision Notice Revision
Number
00 20/09/20 -Added CNF/023/2022 To comply the
21 escalation of GMP and
repeat non regulatory
conformances requirements. -
Provide more
clarity while
performing the
operations.
01 14/10/20 Added QA and CNF/074/2023 Periodic SOP

22 RDTT to SOP review
distribution
-Removed the
name section
on footer
-Grammar
corrections
-Changing
format for
annexure 1000
12.0 REFERENCE:
 PIC/S (PE 009-13)

 EudraLex Volume-4

Signature
Date
Pharmacist

ANNEXURE-I
Space for Space for
COSPHARM PHARMACEUTICALS PVT LTD
f
Controlled Master Copy

QUALITY ASSURANCE DEPARTMENT Copy Stamp Stamp
SELF INSPECTION PLANNER AND EXECUTION RECORD
Year:
Month JAN. FEB. MAR. APR. MAY JUNE JULY AUG. SEP. OCT. NOV. DEC.
Department P/A P/A P/A P/A P/A P/A P/A P/A P/A P/A P/A P/A
Prepared Checked By Approved By

By Production Plant and Human Regulatory Quality Head
Officer/ Pharmacist Validations Capital affairs control QA
Executive Engineer Officer Officer Chemist
QA
Date
Signature
Designatio
n
P: Planned; Tick (√) mark for Planned Month
A: Actual Date of audit
Format No: COS/QAD/010/F01-01 Page No. X of Y

Signature
Date
Pharmacist

ANNEXURE-II
Space for Space for

f

SELF INSPECTION RECORD
Year:
S. Audit Report Department Date of Inspection Sent By Received By Inspection Received By Compliance Closed By Remarks
No. No. Inspected Inspection Report send to QA Auditee Report received QA Verified By QA Pharmacist with Sign
Auditee Sign & Sign & Date By QA Sign & Date QA Sign & Date & Date
Department On Date after CAPA On Sign & Date (If any)
Format No: COS/QAD/010/F02-01

Signature
Date
Pharmacist

ANNEXURE-III
Header for all type of checklist:

Space for Space for
f
Controlled Master
QUALITY ASSURANCE DEPARTMENT Copy Stamp Copy Stamp
SELF INSPECTION CHECKLIST

Checklist No.: SI/001/1.0 Production Audit Report No.:
(Tablet-Granulation)
Body part of all type of checklist:
Point Check Point Yes/No 1 2 3
No.
1. SOPs:
A complete set of applicable SOPs available in the
Section?
Are Obsolete documents removed from the Granulation
Section?
2. Personnel & Hygiene:
Select One employee working in the Granulation
Section. Are their Training Records Available? Is the
Training Matrix updated?
1. ___________
Have the employees undergone training in the following
areas during the last year?
 cGMP
 SOPs
 Granulation Techniques
Question several employees about the operations they
are performing. Are they knowledgeable about their job
functions?
Are all employees attired according to the appropriate
gowning SOP?
Any written procedure are available for personnel
hygiene

Signature
Date
Pharmacist


No.
Are all concern department employees maintaining
hygienic condition as per SOP?
Select One employee working in the Granulation Section
and check his for hygienic condition.
1. ___________
Are all workmen following the instruction manual,
Standard Operating Procedure of process area?
3. Facilities:
Is the Granulation Section maintained in a good state of
repair?
Is the Granulation Section neat and clean with sufficient
space for Equipment and Operations?
Is all the Dispensed Raw Material for one batch kept on
a pallet?
Where more than one pallet is designated for one batch,
is each pallet clearly labeled as one of the total number
of pallets?
Are all door and door interlocking working in proper
condition?
Are all work areas clearly labeled with the name and the
Batch Number of the product being Processed and
Signature of the Production Officer?
Is the Temperature and Relative Humidity maintained in
the Area?
(Observed: Temp. _______,Relative Humidity: _____)
4. Prevention of cross-contamination:
Are doors closed at all times?
Is a personnel clothing Clean, Unstained and Dust Free,
including Shoes?
Are the Return Risers are cleaned during Product
Change Over?

Signature
Date
Pharmacist


No.
What is the quality of the air in the Granulation Section
(filter designation)?
____________________________________________
5. Equipment and Facility Cleaning And Sanitation:

Are pallets and drums brought into the area clean and
free from Powder/Dust/Dirt?
Is the equipment Neat, Clean and Rust Free?
When not in use, is equipment covered so as to Prevent
Accidental Contamination?
Is the equipment suitably designed for its purpose?
Is the equipment constructed so that product contact
surfaces are not reactive or absorptive, so that it will not
contaminate or in any way affect the product being
manufactured?
Is preventive maintenance of equipments/instrument
done as per schedule
Are there specific procedures for the cleaning of major
equipment items?
Select any major equipment used for manufacturing.
Equipment Name: ID No.:
Examine the following records:
* Machine Log Book
* Qualification Documents
* Cleaning Log Book
* Relevant SOPs (Cleaning, Operation & Preventive
Maintenance SOPs)
Visually inspect one piece of equipment that is been
cleaned. Is it cleans?
Is it labeled with respect to its cleanliness status?
Do cleaning procedures include a requirement for the
cleaning of small items?

Signature
Date
Pharmacist


No.
Do cleaning procedures specify the detergent type and
concentration to be used?
Are there records of Cleaning Agent Preparation?
Is there a written procedure for washing the Finger Bags
of Fluidized Bed Dryers?
Are the finger bags dedicated for each product?
How are they stored? Is it satisfactory?
______________________________________________
6. Working Procedures:
Examine the Batch Record for a batch that is being
processed.
Product:_______________ Batch No.: ____________

Is all materials / items are kept on designated place with
identification labels.
Is the BMR used for this batch is control copy of the
master?
Is the record completely and accurately filled out up to
the appropriate stage of processing?
Are all in-process results within the defined limits?
Is there a written procedure for the cleaning of
containers after use?
Is the blend properly labeled?
Is there an SOP defining the maximum storage period of
blend stand prior to compression?
Is it adhered to?
Do yield calculations after Granulation conform to the
relevant SOP?
Is yield calculation performed after each distinct phase
of Production?
 Granulation
 Blending

Signature
Date
Pharmacist


No.
Is there written procedure for Handling of Breakdown of
Equipment and System?
Is there written procedure for Handling of intermediate
products?
Is proper designated place available for storage of
intermediate product?
Is it properly recorded?
Is there a record of checking the sieves and screens
before and after use for signs of damage?
Is any written procedure available for management of
Waste material/scrap material?
7. Lubricants:
Is the equipment designed in such a way that lubricants
not come into contact with components or drug
product?
Is there an approved list of Food-Grade Lubricants for
use where they may contact product?
Is there a written procedure for the receipt and approval
of such Lubricants?
Examine the lubricants available in the Granulation
Section. Are they clearly labeled and stored in a sanitary
manner?
8. Equipment/Instrument Calibration:
Is there an approved schedule for the calibration of all
production equipment/instrument?
Select three equipment items and examine the
calibration records.
1. ___________2. _______________3. ___________
Are the equipment/instrument items identified with a
Distinguishing Code Number?
Is all critical instrumentation on the equipment/
instrument items identified with a valid calibration tag?

Signature
Date
Pharmacist


No.
Physically verify that all instruments found associated
with the equipment are included in the Calibration File?
Do all appropriate personnel approve the Calibration
Reports?
Are the reports completely and accurately filled out?
Where compressed air is supplied to machinery, is it Oil
Free and Filtered?
Is there an SOP for cleaning and replacement of these
filters?
What measures are taken to prevent cross-
contamination of product from these filters when inlet
air is not functioning?
______________________________________________
______________________________________________
9. Filters:
Do they maintain the record of Filters?
Is there written procedure for Cleaning of Filters at the
time of Product Changeover?
Do they check the Filter Integrity on routine basis?
10. Labels:
Are the status labels affixed to all Equipments?
Is the status labels duly signed by Production Officer?
Is the status board bears necessary information?
Is the storage of label done as per designated place?
11. Documentation:
Are all daily documents filled correctly and timely?
Are the formats, logs are current?
Has all SOPs related with the Equipment or the Process
been Displayed?
Is any Obsolete Copy seen in the Granulation Section?
12. Qualification and Validation:

Signature
Date
Pharmacist


No.
Is there an Approved Annual Program for the
qualification and validation of all granulating
equipments?
Select one Vibro Sifter, RMG, FBD, Blender and Mill and
Examine the Qualification Record?
Is the machine identified with a Distinguishing Code
Number?
Are the reports approved by all Appropriate Personnel?
Space for Space for

f
Controlled Master

(Tablet-Compression)

No.
1. SOPs:
Is a Complete Set of Applicable SOPs available in the
Compression Section?
Are the Obsolete documents removed from the
Compression Section?
Select three employees working in the Compression
Section. Are their training records available? Is the
training matrix updated?
1. _________ 2. ____________3. _______________

Signature
Date
Pharmacist


No.
Have the employees undergone training in the
following areas during the last year?
 GMP
 SOPs
 Compression Techniques
are performing. Are they knowledgeable about their
job functions?
gowning SOP?
Are concern department employees proper in hygienic
condition?
hygiene
hygienic condition as per SOP.?
Select One employee working in the compression
Section and check his for hygienic condition.
1. ___________
3. Facilities:
Is the Compression Section maintained in a good state
of repair?
Is the Compression Section neat and orderly with
sufficient space for equipment and operations?
Is all compressed tablet kept on the pallets?
Is all work areas cleared labeled with Name & Batch
Number of the Product being processed & sign of the
Production Officer?
condition?

Signature
Date
Pharmacist


No.
Is the Temperature and Relative Humidity maintained
in the Area?
Observed. Temp: ______Relative Humidity: ______
Is a Personnel Clothing Clean, Unstained and Dust
Free, including Shoes?
Change Over?
What is the quality of the air in the Compression
Section
(Filter Designation)?
_______________, ________________.
Are their approved SOPs for the maintenance of
ceiling filters?
5. Equipment and facility cleaning and sanitation:
Are In-process container or bin brought into the area
clean and free from Powder/Dust/Dirt?
Is the Equipment Neat, Clean and Rust Free?
When not in use, is Equipment covered so as to
prevent accidental contamination?
Is the Equipment suitably designed for its purpose?
Is the Equipment constructed so that product contact
surfaces are not reactive or absorptive, so that it will
not contaminate or in any way affect the product
being manufactured?
Are there procedures for the cleaning of Compression
Machine?

Signature
Date
Pharmacist


No.
Select a Compression Machine.
ID No.:
Examine the following Records:
* Machine Log Book
* Cleaning Log Book
* Relevant SOPs (Cleaning , Operation & Preventative
Maintenance SOPs)
Visually inspect one machine that is not in use, Is it
labeled respect to its cleanliness status? Is it clean?
done as per schedule?
cleaning of small items (e.g. Scoop)?
Do cleaning procedures specify the Cleaning Agent and
Is the cleaning agent available in the Compression
Section identical to those listed in the cleaning
procedures?
Are there cleaning agent labeled with a catalog
number indicating that they were received through
the warehouse?
Are there records for cleaning agent preparation?
Examine the record of the daily & monthly calibration
of balances in the Compression Section. Is it complete
and accurately filled out?
Are all results within the Specification?
If not, is there a record of the implementation of
Corrective Action?

Signature
Date
Pharmacist


No.
Perform a visual examination of the weights with
which the check is performed. Are they kept in the
Weight Box ?
Are they clean?
Do they bear a Valid Calibration Seal?
processed.
Product: ____________ Batch No.: ___________
Is the Batch Manufacturing Record signed as being a
control copy of the master?
Have any changes to the process or equipment been
authorized by QA?
Is the Speed of Compression Machine written on the
batch record?
Do the working pressure and machine speed conform
to the required standards?
Examine the containers used for collecting tablets.
Are they correctly labeled?
Waste material / scrap material?
Is there a SOP for inspection the punches and dies
after each use for signs of deterioration (gouging,
chipping, corrosion, etc.) that could impact the
tablets?
Is there written procedure for Handling of
intermediate products?
7. In-Process Control:
Is there an approved SOP for in process checked?

Signature
Date
Pharmacist


No.
Does the SOP state at what frequency tests must be
performed by?
Examine a batch record. Is the test frequency adhered
to?
Product Name:____________B. No.: _____________
Do all test results conform to Specifications?
Is all testing Instruments labeled with a Valid
Calibration Label?
1. _________________2. __________________
3. _________________4. __________________
5. _________________6.___________________
Is the SOP specific with regard to corrective action in
the event that results do not conform to
Specifications?
Examine a Batch Record.
Product Name: __________, Batch No.: __________

Do the recorded Specifications conform to the
Approved Product Specifications?
Are results recorded in the correct units as stated on
the form?
Are Tablets stored in Bulk Containers before Coating
and/or Packaging?
Examine the lubricants available in the Compression
Section. Are they clearly labeled and stored in a
sanitary manner?
Is there an Approved Program for the Calibration of all
Compression Machines?
Select one Compression Machine and Examine the
Calibration Record?
Number?

Signature
Date
Pharmacist


No.
Is all-critical instrumentation identified with a Valid
Calibration Label?
Physically verify that all instruments found on the
machine are included in the Calibration File.
Are the reports approved by all Appropriate
Personnel?
9. Labels:
Are the status labels affixed to the equipments?
Is the status labels are duly signed by Production
Officer?
10. Documentation:
As the formats, logs are current?
Has all SOPs related with the Equipment or the
Process been Displayed?
Is any obsolete copy seen in the Compression Section?
Is there an Approved Program for the qualification and
validation of all compression equipments?
Select one compression machine and Examine the
Qualification Record?
Number?
Are the reports approved by all Appropriate
Personnel?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

(Tablet-Coating)
Point
1.1.1.1.1.1 Check Point Yes/No 1 2 3
No.
1. SOPs:
Is a Complete Set of Applicable SOPs available in the
Coating Section?
Obsolete documents removed from the Coating
Section?
Select One Employee working in the Coating Section.
Are their Training Records available? Is the Training
Matrix updated?
1.____________
Have the Employees undergone training in the
 GMP
 SOPs
 Coating techniques
Question several Employees about the Operations they
are Performing. Are they Knowledgeable about their
Job Functions?
Gowning SOP?
condition?

Signature
Date
Pharmacist

Point
No.
hygiene
Select One employee working in the coating Section
1. ___________
3. Facilities:
Is the Coating Section maintained in a good state of
repair?
Is the Coating Section neat and orderly with sufficient
a Pallet wrapped in Polythene?
Is the Liquid Raw Material used for Coating kept in
clean and closed Containers?
Are all work areas clearly labeled with the name and
the Batch Number of the Product being processed and
sign of Production Officer?
in the Area?
(Observed: Temp._____, Relative Humidity:______)
Are Doors closed at all times?
Is Personnel Clothing Clean, Unstained and Dust Free,
including Shoes?
Change Over?

Signature
Date
Pharmacist

Point
No.
What is the quality of the air in the Coating Section
(Filter designation)?
_________________ , ___________________
Are there approved SOPs for the Maintenance of
Ceiling Filters?
Are In-process containers brought into the area clean
and free from Powder/Dust/Dirt?
Is the Equipment neat, clean and rust free?
Is the Equipment suitably designed for its purpose?
Is Equipment constructed so that product contact
not contaminate or in any way affect the product being
manufactured?
Are there specific procedures for the cleaning of Tablet
Coating Machine?
Is preventive maintenance of equipments / instrument
Select a Coating Machine.
ID No.:
* Machine Log Book
* Qualification Status
* Cleaning Log Book
* Relevant SOPs (Cleaning, Operation & Preventative
Maintenance SOPs)
Visually inspect one piece of Equipment that is been
cleaned. Is it clean?
cleaning of Small Items?

Signature
Date
Pharmacist

Point
No.
Are all results within the Specifications?
Corrective Action?
Examine the batch record for a batch that is being
processed.
Product : ___________Batch No.: ______________
Is the BMR used for this batch is a control copy of the
master?
Examine the bin used for collecting Tablets?
Is the weight recorded after completion of coating?
products?
7. In-Process Control:
Is there an approved SOP for in-process control?
performed by Production and QA personnel?
to?
8. Equipment/Instrument calibration:
Is there an approved schedule for the Calibration of all
Coating Instruments?
Select one Coating Machine and examine the
Calibration Record.

Signature
Date
Pharmacist

Point
No.
Is the Machine identified with a Distinguishing Code
Number?
Is all Critical Instrumentation identified with a Valid
Calibration Label?
9. Filters:
10. Labels:
Are the Status Labels affixed to all Equipments?
Is the Status Labels duly signed by Production Officer?
Is the Status Board bears necessary information?
11. Documentation:
As the formats, logs are current?
Has all SOPs related with the equipment or the process
been displayed?
Is any obsolete copy seen in the Coating Section?
validation of coating equipments?
Select one coating machine and solution tank and
Number?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

(Tablet-Capsule Section)

No.
1. SOPs:
Is a Complete Set of applicable SOPs available in the
Section?
Are the SOPs current?
Is the set of SOPs correctly organized according to the
Index?
Are Obsolete documents removed from the Capsule
Section?

Select one employee working in Capsule Section. Are
their Training Records available? Is the Training matrix
updated?
1. ____________
Has the Employee undergone Training in the following
 GMP
 SOPs
 Capsule Filling Techniques
Question several Employees about the Operations they
Job Functions?
Are all Employees attired according to the appropriate
gowning SOP?

Signature
Date
Pharmacist


No.
condition?
hygiene
Select One employee working in the capsule Section
1. ___________
3. Facilities:
Is the Capsule Section maintained in a good state of
repair?
Is the Capsule Section neat and orderly with sufficient
Is all Dispensed Raw Material for one batch kept on a
pallet wrapped in a polythene
Examine the area at the end of a day’s work. Is it left
neat and tidy?
the batch number of the product being processed?
in the Area?
Observed:Temp.______,Relative Humidity :_______
Is Personnel Clothing Clean, Unstained and Dust Free,
including Shoes?
Change Over?

Signature
Date
Pharmacist


No.
What is the quality of the air in Capsule Section (filter
designation)?
___________________ , _____________________

Are Pallets and Drums brought into the Area Clean and
Free from Powder/Dust?
Is the Equipment Neat, Clean and Rust Free?
Is Equipment suitably designed for its purpose?
Is Equipment constructed so that product contact
manufactured?
Select a Equipment:
Examine the following records :
* Machine Log Book
* Cleaning Log Book
* Relevant SOPs (Cleaning, Operation & Preventative
Maintenance SOPs)
Select one batch recorded on the Machine Log Book
and thoroughly check that Batch Record.
Product Name: ________________________
B. No.: _______________________________
Is the cleaning correctly recorded on the Area Cleaning
Record?
Visually inspect one machine that is not in use.
Is it clean?

Signature
Date
Pharmacist


No.
Do Cleaning Procedures include a requirement for the
cleaning of small items (e.g., Balances, etc.)?
Do Cleaning Procedures specify the cleaning agent and
Is the Cleaning Agent labeled with a catalogue number
indicating that they were received through the
Warehouse?
Are the records of Cleaning Agent Preparation?
6. Working procedures:
Examine the record of the Daily & routinely Calibrations
& check of balances in Capsule Section.
Is it complete and accurately filled out?
Are all results within the Specifications?
Corrective Action?
Perform a visual examination of the weights with which
the check is performed.
Are they in a good state of repair?
Are they clean?
Do they bear a Valid Calibration Seal?
processed.
Product : __________Batch No.: ______________
Is the Master Batch Manufacturing Record signed as
being an accurate copy of the original?
Is the speed of filling recorded in the batch documents?
Does the filling speed conform to the required
parameters?
Is the suction system filling during work?

Signature
Date
Pharmacist


No.
Question the employees. Does he or she know what
the correct procedure is if the suction system stops
functioning?
Do yield calculations after Capsule Filling Conform with
the relevant Batch Records?
Has BMR been completed and an investigation
conducted. If any?
Is the yield checked by a Production Officer?
Examine the bins used for collecting Capsules?
Is the weight recorded after completion of filling?
Is there an SOP for monitoring capsule weight during
production?
Is it followed?
If necessary, is there an SOP for Inspection Capsules
after Filling?
Is it followed?
products?
7. In Process Control:
Is there an approved SOP for In-Process Control?
performed by Production Officer/Executive and QA
Officer/Executive?
to?

Signature
Date
Pharmacist


No.
Is the SOP specific with regard to corrective action in
the event that results do not conform to specifications?
Is there an SOP for collecting the sample for final
testing by Quality Control?
Is the SOP followed?
Is all testing instruments labeled with a valid Calibration
Label?
Is there an Approved Schedule Program for Calibration
of all Equipment/Instrument?
Select one machine and examine the calibration record.
Machine: ____________________________________
Is the Machine Identified with a Distinguishing Code
Number?
Are all Critical Instrumentation/Equipment identified
with a valid Calibration Label?
Physically verify that all Instruments found on the
machine are calibrated.
Cross-check with the Calibration Records that the
Instruments have the same Classification in the
Calibration Report.
9. Filters:
10. Labels:
11. Documentation:

Signature
Date
Pharmacist


No.
been Displayed?
Is any Obsolete Copy seen in the Capsule Section?
validation of all capsule equipments?
Select one Vibro sifter, capsule filling machine and
Number?
Space for Space for

F
Controlled Master

Checklist No.: SI/005/1.0 Production Packing Audit Report No.:

No.
1. SOPs:
Are a complete index and a complete set of applicable
SOPs available in the Area?
Are the index and the SOPs current?
index?
Is the Obsolete documents removed from the Area?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Select three employees working in the Area. Are their
training records up-to-date?
1. ___________2. ___________3. _____________
 GMP
 SOPs
 Packaging techniques
job functions?
gowning SOP?
When necessary, do operators wear masks and gloves?
hygiene
Select One employee working in the packing Section
1. ___________
3. Facilities:
Is the department maintained in a good state to repair?
Is the department neat and orderly with sufficient
space for equipment and operations?
Examine the area at the end of a day’s work. Is it left
neat and tidy?
the batch number of the product being processed?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Is there adequate physical separation between
different packaging lines to prevent mix-ups and/or
cross- contamination?
Are all parts of the line where product or primary
packaging components are exposed covered to prevent
accidental contamination of the product?
Is relative humidity control employed in areas where
moisture sensitive drugs are packaged?
Examine the records for moisture–sensitive drug that
was processed recently. Is the relative humidity
recorded in the batch record?
Does the relative humidity conform to specifications?
4. Prevention of Cross-contamination:
including Shoes?
5. Equipment and Facility Cleaning and Sanitation:
manufactured?
equipment items?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

* Machine Log Book
* Cleaning Log Book
Maintenance SOPs)
Is there documented evidence that the cleaning of
packaging equipment?
packaging equipment
 Between batches of the same product?
 Between batches of different products?
Is the procedure specific to a particular machine?
Does the procedure specify which parts of the machine
must be disassembled for cleaning?
Examine the machine logbook for the product currently
being packed. It is filled out with all the required
information?
processed.
Product:_______________ Batch No.: ____________
Is all materials/items are kept on designated place with

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Is the BPR used for this batch is an control copy of the
master?
Are all In-process results within the defined limits?
7. Lubricants:
Is the equipment designed in such a way that lubricants
not come into contact with components or drug
product?
Is there an approved list of Food-Grade Lubricants for
use where they may contact product?
Is there a written procedure for the receipt and
approval of such Lubricants?
Examine the lubricants available in the Granulation
Section. Are they clearly labeled and stored in a
sanitary manner?
8. Process Control:
Examine the records for the batch being processed. Are
there written?
Is the frequency of checks in accordance with the
relevant SOP?
If the packaging operation continues over more than
one shift, is there a written requirement for re-
verification of all electronic controls?
Is this performed?
Is there a written procedure for the examination of
packaged product during finishing operations to ensure
correct labeling?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Is a representative sample of units collected and
visually examined for correct labeling?
production Equipment/Instrument?
Select two equipment items and examine the
1. ___________2. _______________3. ___________
Reports?
Where compressed air is supplied to machinery, is it Oil
Free and Filtered?
filters?
_____________________________________________
_____________________________________________
10. Labels:
Are the status labels affixed to all equipments?

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

11. Documentation:
Has all SOPs related with the Equipment or the process
been displayed?
Is any obsolete copy seen in the department?
qualification and validation of all equipments?
Select one Machine and Examine the Qualification
Record?
Number?
Space for Space for

F
Controlled Master

Checklist No.: SI/006/1.0 Quality Control Department Audit Report No.:
(Chemical)

No.
1. SOPs:
Is a complete index and a complete set of applicable
SOPs available in the department?
index?

Signature
Date
Pharmacist


No.
Obsolete documents removed from the Department.
Select three Employees working in the department.
Are their training records up-to-date?
1._________ _2._____________ _3._____________
Have the Employees undergone training in the
 GLP
 SOPs
 Analytical techniques
Question Several Employees about the operations they
job functions?
Have the Employees undergone Qualification
according to the relevant SOP?
Are detailed, written job descriptions available for all
Employees?
condition?
hygiene
Select One employee working in the QC Section and
check his for hygienic condition.
1. ___________
3. Facilities:
Is the laboratory maintained in a good state of repair?
Is the laboratory neat and orderly with sufficient space
for Equipment and Operations?

Signature
Date
Pharmacist


No.
Is there evidence of good housekeeping?
4. Instrumentation and calibration:
Is there an approved Preventative Maintenance
Program for all Instruments used in the Laboratory?
Is there evidence that it is followed?
Is the program based on Manufacturer’s
Recommendations?
If not, is there a Documented Rationale for the
Alteration of the Schedule?
Is there Documented Evidence that the person who
performs the Preventative Maintenance is Qualified to
do so?
Select three major Instruments used in the Laboratory.
1) _____________ ID No.: ___________
2) _____________ ID No.: ___________
3) _____________ ID No.: ___________
Are there written Procedures for Operating the
Instruments?
Are there written Procedures for Calibration of
Instruments?
Is there a valid Calibration Label on each Instrument?
Examine the Calibration Records for the Instruments.
 Are they up-to-date?
 Are the results within Limits?
Is there SOP for Corrective Action in the event that an
Instrument is found to be out of Calibration?
Are standards used to Calibrate an instrument, is there
a written procedure for their Preparation?
Is there SOP for cleaning of Quality Control Glassware
and Instruments?
Is the cleaning procedure validated?

Signature
Date
Pharmacist


No.
Are all glassware calibrated as per written procedure?
Is there proper and adequate lighting system in the
lab?
Is storage of chemicals and reagent as per designated
place and proper labeling available?
Are all record of reagent and chemical available?
Are every individual who is a part of the laboratory
and engaged in conducting testing shall have the
requisite educational qualification, training, and
experience available?
Are Regular training provided by the Approved Trainer
to all personal working in QC Lab?
5. Sampling receipt, storage and documentation:
Is a specific person responsible for the receipt of
samples for testing?
Is there a written SOP describing sample receipt and
recording (logging in)?
Where are samples stored before and after testing?
Are samples retained after testing is complete?
What happens to samples retained after testing and
reporting are complete?
Is there a time limit on how long a sample may remain
in the laboratory prior to testing?
6. Test Procedure:
Are there approved specifications available for all
products, raw materials and packing materials?
Are there approved test procedures available for all
tests performed in the Laboratory?
Is there a written procedure for ensuring that all
Pharmacopoeia procedures are updated when a
supplemental monograph is issued?
7. Repeat Testing:

Signature
Date
Pharmacist


No.
Is there an SOP for repeat testing
 On the same sample?
 On a new sample?
Does the SOP require supervisory intervention prior to
repeating any test?
Does the SOP describe a procedure for Invalidating
Results?
Does the procedure require a written explanation of
the reason for the retest?
8. Evaluation/Supervision of Results:
Is there an SOP for review of test data and
calculations?
Are raw data reviewed prior to release from the
Laboratory by a person other than the analyst who
performed the test?
Are log books routinely reviewed by a supervisor?
Are true data along with the audit trials reviewed
before preparing the final COA?
Take one released sample & check the data with
specification along with audit trials on system:
Product/Material:
Batch No./AR No.:
Do reviewers sign the log Book to indicate that it has
been reviewed?
9. Reference and Working Standards:
Are they following the procedure of SOP for the
Preparation and Handling of reference and working
Standards?
Are the Reference and Working Standards are stored
according to the Recommended Storage Conditions?
Do they maintain the record of Preparation, Storage
and Destruction of Reference and Working Standards?

Signature
Date
Pharmacist


No.
10. Other:
Do they maintain the record of Stability Studies?
Do they maintain the record of Receipt, Issuance,
Usage and Destruction of Columns?
waste material/scrap material?
Is the list of Authorized Person displayed on restricted
entry?
Are the Status Labels affixed on Instruments?
Do they maintain the record of Preparation of Reagent
Solutions?
Is there approved procedure for destruction of reagent
solutions?
Is there written procedure or any agreement for
perform tests from outside laboratory?
Is there any SOP for handling of Hazardous and
Poisonous Chemicals?
11. Calibration of Instruments & Measurement Systems:
Is the SOP available for Calibration of Instruments?
Is the Calibration SOP followed?
Is any Annual Program available for Calibration?
Is the contract given to any External Party for
Calibration?
How is it traceable that the Instruments are
Calibrated?
____________________________________________
____________________________________________
____________________________________________
___________________________________________
Is the Instrument bearing a Calibration Tag?

Signature
Date
Pharmacist


No.
Is the Calibration Tag bears
i. Date of Calibration
ii. Instrument No.
iii. Location
iv. Calibration Due On
v. Signature
Is the Standard Instrument from which calibration is
done has been calibrated from NABL certified agency?
Do they have Calibration Certificate?
Select any balance in the Department. Is the Calibration
Report available?
Is this Report bears:
i. Name of Calibrator
ii. Name of Instrument, Location, Type, Make,
Model, Least Count
iii. Specific Accuracy, Acceptance Criteria, Range,
Input Output
iv. Test Equipment used along with Make, Range,
Accuracy, Validity, Calibration done by checked by
etc.
Are all results within the limit?
Are all formats used for Calibration Record Current?
Is the report bears Acceptance Criteria?
Is there any SOP available which includes Instrument
to be Calibrated & Frequency of Calibration?
Is this SOP followed?
How is it Traceable?
____________________________________________
_______________________

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Checklist No.: SI/007/1.0 Quality Control Audit Report No.:
(Microbiology Laboratory)

No.
1. SOPs:
SOPs available in the Section?
Are the index and the SOPs Current?
Index?
Is the Obsolete documents removed from the
Department?
Select three Employees working in the Department.
Are their training records up-to-date?
1.___________ 2.____________ 3._____________
 GLP
 SOPs
 Microbiological Techniques
are performing.
Are they knowledgeable about their Job Functions?
Are detailed, written job descriptions available for all
Employees?
hygiene.

Signature
Date
Pharmacist


No.
Select One employee working in the Micro Section and
1. ___________
Standard Operating Procedure of process area.
3. Facilities:
Is the laboratory maintained in a good state of repair?
Is the laboratory neat and orderly with sufficient space
Is there evidence of Good Housekeeping?
Is the clean room maintained in a good state of repair?
Is there an SOP for the cleaning and disinfection of the
Clean Room?
Is the Microbiological Section provided with an Air
Locks and Laminar Flow?
Are all Reagents and Solutions?
 Clearly labeled with their proper name?
 Labeled with date of receipt and/or Expiration
Date?
Waste material/Scrap Material?
Are prepared solutions labeled with the
 Name of Person who prepared them?
 Date of Preparation
 Expiration Date
Are there records of the Preparation of Disinfectants?
Are disinfectants labeled with Expiration Dates?
Are cleaning records available and correctly Filled Out?
4. Equipment and Instrumentation:
Is there an Approved Preventative Maintenance
Program for all Equipment used in the Laboratory?
Is there evidence that it is followed?

Signature
Date
Pharmacist


No.
Select three pieces of Equipment used in the
Laboratory.
1.________________
2.________________
3.________________
Are there written procedures for operating the
Equipment?
Is there a valid Calibration Sticker on each Instrument?
Are Temperature Recorders attached to all Incubators
and Refrigerators?
Is there an approved SOP that requires the Routine
checking and signing of Temperature Charts?
Is there an SOP defining cleaning and sanitization
procedures for the incubators and Refrigerators?
Is there documented evidence that it is being
followed?
Examine the most Recent Validation for the Auto clave.
Was the Validation performed on Schedule?
Do the results meet the Relevant Acceptance Criteria?
Is there proper and adequate lighting system in the
lab.
Is storage of chemicals and reagent as per designated
place and proper labeling available?
Are all record of reagent and chemical available?
Are every individual who is a part of the laboratory and
engaged in conducting testing shall have the requisite
educational qualification, training, and experience
available?
Are Regular training provided by the Approved Trainer
to all personal working in Micro Lab?
5. Sampling Receipt, Storage And Documentation:
Is a specific person responsible for the receipt of
samples for testing?

Signature
Date
Pharmacist


No.
Is there a written SOP describing sample Receipt and
Recording (logging in)?
Where are samples stored before and after Testing?
___________________________________________
Are samples retained after testing is Complete?
What happens to samples retained after testing and
Reporting are complete?
___________________________________________
Examine the contents of a Refrigerator and an
Incubator.
Is the Equipment Clean?
Are all test samples recorded in the Laboratory Log
Book?
Are all items clearly labeled?
6. Test Procedure:
Are there approved test procedures available for all
tests performed in the Laboratory?
Is there a written procedure for ensuring that all
Pharmacopoeial Procedures are updated when a
Supplemental Monograph is issued?
Are records available for the preparation of media
used for performing the test?
Is the medium labeled with an Expiration date?
Is labeling in accordance with an approved SOP?
7. Recording Results:
Examine any analyst’s Test Report.
Are any cross-outs initialed and dated?
Are all calculations recorded?
Is there a statement in the Test Report as to whether
or not the sample passes the test?
Is the analyst’s signature recorded in the Test Report?

Signature
Date
Pharmacist


No.
8. Stock Cultures:
Is there an SOP for the receipt and Handling of
Cultures?
Are cultures received with a certificate of analysis?
How often cultures are transferred?
___________________________________________
Is there a maximum number of times cultures may be
transferred?
Is it adhered to?
9. Repeat Testing:
Is there an SOP for Repeat Testing
 On the Same Sample?
 On a New Sample?
Does The SOP Require Supervisory Intervention Prior
To Repeating any Test?
Does the SOP describe a procedure for invalidating
results?
Is periodic follow-up performed to assess how many
retest are being performed?
Examine results of LAL Endotoxin Testing for the past
Six Months.
Have any Retest been performed?
If yes, is an investigation report/invalidation of the first
test available?
Examine investigation reports for any repeat sterility
tests performed within the past year.
10. Evaluation/Supervision of results:
Is there an SOP for review of test data and
calculations?
Are raw data reviewed prior to release from the
laboratory by a person other than the analyst who
performed the test?

Signature
Date
Pharmacist


No.
Do reviewers sign the Test Report to indicate that it
has been reviewed?
11. Environmental and Periodic Monitoring (Clean Room):
Is there an SOP for monitoring Differential Air
Pressures?
Are there written records of air pressure checked and
signed?
Is there an SOP for Environmental Monitoring in the
Clean room?
Do results conform to the limit stated in the SOP?
When Out-of-Limit results were obtained, was
Corrective Action implemented in accordance with
SOP?
Examine records of monitoring for the Past Three
Months.
Are there records of checking Laminar Airflow
Velocities?
Are there records of checking Air Changes in the Area?
12. Culture Media:
Is there SOP for Preparation, Issuance, Storage,
Handling, Usage and Destruction of Culture Media?
Space for Space for

F
Controlled Master

Checklist No.: SI/008/1.0 Quality Assurance Department Audit Report No.:

No.
1. SOPs:

Signature
Date
Pharmacist


No.
SOPs available in the department?
index?
Is up-to-date document of list of product, list of master
document available?
Obsolete documents removed from the Department.
Are the SOPs available for specific operation in stores,
production, QC, engineering, safety and ETP?
Is there an SOP available for preparation of SOP?
Are there SOP available for control and distribution of
master documents?
Is there an SOP for preparation, approval and
authorization of document available?
Is there any list of Quality Assurance procedure
available?
Is there an SOP for numbering of batch available?
Is there any system of issuing batch document?
Is there plan for Validation/Qualification programme?
Are the validation/qualification programme conducted as
per the schedule?
Are there complete index of validation protocols
available?
Is there an SOP for vendor selection approval programme
available?
Select three employees working in the department. Are
their training records up-to-date?
1. ____________ 2. ____________ 3. ___________

Signature
Date
Pharmacist


No.
 GMP
 SOPs
 Quality Assurance responsibilities
functions?
gowning SOP?
Is detailed, written job description available for all
employees?
Is an up-to-date organizational chart of the Quality
Assurance Department available?
condition?
hygiene
Select One employee working in the QA Section and
1. ___________
3. Batch Record Review:
Is there a SOP for batch record review prior to release?
Is there a comprehensive checklist for batch record
review prior to release?
Is there a tracking procedure in place to ensure that a
batch record with a deviation report attached to it
cannot be released prior to the completion of any
required investigation?

Signature
Date
Pharmacist


No.
Examine recently released any one batch record from
each section
Product: Batch No.:
Product: Batch No.:
Product: Batch No.:
4. Are the records complete with respect to the following?
 Any changes to the Batch document are QA
authorized prior to manufacturing.
 All relevant signatures are present.
 All relevant data are present
 All relevant data are accurate.
 Yield calculation at each stage of production
conforms to the SOP.
1. All calculations are verified by a second individual.
2. Any deviations are justified, fully explained and
authorized.
5. Deviation Reports:
Select three deviation reports prepared within the last
six months
Deviation No. :
Deviation No. :
Deviation No. :
Were the Deviations completed prior to release of the
batch?
Does the relevant SOP require a written investigation and
follow-up on implementation of recommendations?
Are the Deviations filled out in accordance with the SOP?
If necessary, is there a fully documented investigation?
Have recommendations been made to prevent the
deviation from recurring?
Have recommendations for corrective action been
implemented?

Signature
Date
Pharmacist


No.
Examine the daily deviation reports from the three
months preceding the audit. Is there follow-up
procedure?
Select three reports at random. Are they filled out in
accordance with the relevant SOP?
Review the monthly summaries of all deviations (not
product specific) for the six months preceding the audit.
Are there deviations that reoccur more than once?
6. Change Control Records:
Are all changes that may impact product quality
authorized by Quality Assurance prior to
implementation?
Examine three recent change control forms.
Change Control:
1. ______________, 2. ___________, 3.____________
Have the forms been completed and the results
evaluated prior to closing the forms?
Has all relevant documentation been updated? Verify
that validation protocols have been revised where
appropriate.
7. Product Quality Review:
Examine any one Product Quality Review completed.
Product : Compilation Date :
Does the review comment on any out-of-limit unusual
results?
Does the review include No. of release batches?
Is there a record of examination of reserve samples for
the products reviewed? Were the samples found to be
satisfactory?
Have recommended corrective actions been
implemented?
8. Self-Inspection:

Signature
Date
Pharmacist


No.
Is there a SOP that requires that Self-inspection be
performed in all departments?
Is self-inspection performed according to the frequency
stated in the schedule?
Is there tracking system that all points raised during self
inspection been compiled.
Do all personnel required by the SOP to participate in
inspections actually do so?
Are written reports available for all inspections
performed during the past year?
Is there written evidence of corrective action
implemented as a result of the inspections?
9. Complaints:
Is there an SOP for dealing with complaints?
Examine three recent complaints files.
Product : Batch No.:
Does the summary of complaints available?
Have the files been investigated for the relevant
personnel?
Could any of the above complaints for the year preceding
the audit. Are there products that have several
complaints and if so has appropriate action taken?
Examine the list of complaints for the year preceding the
audit. Are there products that have several complaints
and if so has appropriate corrective action been
implemented?
10. Material Destruction Note:

Signature
Date
Pharmacist


No.
Is there an SOP for destruction of:
 Product components and packaging materials?
 Raw-material?
 In-process material?
 Finished product?
Examine the Material destruction records.
Is it identical to that in the Store?
Are all goods destruction forms QA approved prior to
destruction or as per SOP?
Is there written evidence that the destruction order has
been carried out?
11. Release of Batches:
Is there an SOP for release of batch?
What is the designation of the person doing batch
release? _____________________
Is he/she qualified?
Is there system to ensure that how many batches are to
be released on one day?
Is there a written investigation, including conclusion and,
if appropriate, follow-up action for each of the batches?
Is there pre dispatch checklist available?
12. Rejected Batches:
Examine the list of rejected batches for the current year.
Select three batches.
List the reason (s) for the rejection.
Specify at which stage of production the batches were

rejected.
______________________________________________

Signature
Date
Pharmacist


No.
Is there a written investigation, including conclusion as to
the cause of the failure and, if appropriate, follow-up
action for each of the batches?
Are there any products that have more than one rejected
batch and, if so, has corrective action been
recommended and implemented?
13. Returned Goods:
Is there a written procedure for holding, testing and
reprocessing returned drug products?
Examine the list of returned goods for the current year.
Select three batches?
Is there a record for each batch, including the following
details?
 Name of customer
 Name and strength of the product
 Batch Number
 Reason for return
 Quantity return
 Date of disposition
 Ultimate disposition
List the reason (s) for the return
_______________________________________________
_______________________________________________
________________________________________
List the disposition of the returned goods.
_______________________________________________
_____________________________________________

Signature
Date
Pharmacist


No.
Is the disposition adequately justified with a documented
investigation and conclusions authorized by Quality
Assurance?
Could the reason for any of the returns implicate other
batches of the product and, if so, has an investigation
been initiated and appropriate action taken?
14. Recalls:
Is there a written procedure for the recall of drug
products that ensures that responsible officials of the
firm are notified in writing of the recall?
Have there been any recalls during the current year?
Specify:
List the disposition of the recalled goods.
_______________________________________________
_______________________________________________
______________________________________
Is the disposition adequately justified with a documented
investigation and conclusions authorized by Quality
Assurance?
Could the reason for the recall implicate other batches of
the product and, if so, has an investigation been initiated
and appropriate action taken?
15. Calibration, Validation & Revalidation Systems:
Is there validation master plan available?
Is it followed?
Check the validations actually done against the master
validation plan.
After a completion of three batches, does summary
available for product?
Check the filing system of the filled validations? Is system
satisfactory?
Select any one product & check the all validation related
with it. Does any deficiency found?

Signature
Date
Pharmacist


No.
Does all the results within specification?
Check the batch manufacturing record & validation
reports of the same batches & check the in process
observation. Do they comparable?
Do the list of Master validation protocol available?
Does all master validation protocol available? Duly
authorized?
Check the transport validation of the product available
16. Documentation:
Does following approved document available with the department?
Site Master File
Quality Manual
Validation Master Plan
Layout of buildings & facilities
List of Qualified persons in all department
List of Products
Schedules (Self inspection, Calibration and Qualification,
Risk Assessment and Training etc.)
Does the Retrieval system of the batch documents
satisfactory? How it traceable is that document has been
withdrawn & kept back?
Select any three batch No. from batch No. Register and
check in the storage area.
How much time is required for retrieval?
_______________

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Checklist No.: SI/009/1.0 Human Capital and Audit Report No.:
Administration Department

No.
1. SOPs:
Is a Complete Index and a Complete Set of
applicable SOPs available in the Section?
Are the Index and the SOPs current?
Is the set of SOPs correctly organized according to
the Index?
Are the Obsolete documents removed from the
Section?
Select three employees working in the
Department. Are their Training Records available?
Is the Training Index updated?
1. ________________ 2. ___________________
3.___________________
Have the Employees undergone Training in the
 GMP
 SOPs
 HR Policies
Question several Employees about the Operations
they are performing. Are they knowledgeable
about their Job Functions?
Is there SOP for Induction Training of New
Entrants?
Are concern department employees proper in
hygienic condition?

Signature
Date
Pharmacist


No.
hygiene
Are all concern department employees
maintaining hygienic condition as per SOP.?
Select One employee working in the HRA and
1. ___________
3. Employment Procedure:
What is the designation of the person conducting
interviews?
________________________________________
Does list of persons working in the factory
available?
Does all records of persons working in the factory
segregated person wise?
Is their filing system satisfactory?
Is the person called for interview properly
judged?
Do medical examination of new entrant perform?
Is the physician approved & qualified?
Does the medical examination test includes eye
examination (Colour Blindness), Pathological Test
(Blood & Urine Test), Chest ‘X’ Ray, VDRL, ECG.
Does any Annual Medical Examination carried
out?
4. Security:
Is the enough staff available for security?
Is each person monitored entering inside the
company & while going outside?

Signature
Date
Pharmacist


No.
Does any camera system available to monitor
entry & exit procedure?
Does any match box, chewing, cigarettes, allowed
inside factory premises?
Other than temporary & permanent employees, if
any new person visits, how he is identified?
________________________________________
Is the procedure satisfactory?

Is the name of person visited been documented?
If the vehicle inside the factory premises has been
checked while entry & exit?
5. Building and Surrounding:
Does area sufficient for manufacturing of the
products?
Is the building paint in good condition?
Is any sign of fungal growth on walls of building?
Do the buildings fulfill the FDA & other Regulatory
Bodies requirement?
Does there any wastage from near most factories
come in contact with the Building at our end?
6. Canteen Facility:
What is the precautionary activity done for Pest
Control?
Is the Cleaning record available?
Is the location of Canteen satisfactory?
Is the waste of canteen not contaminate the
manufacturing building and Product?
Is the seating arrangement in the canteen
satisfactory?
Is the quality of food is good and hygienic?
7. Others:
Is there SOP for cleaning of company shoes?

Signature
Date
Pharmacist


No.
Is it followed?
Is the shoe racks and Garment Cabinets available
in the Change Rooms?
Is there SOP for cleaning of Shoe Racks and
Garment Cabinets?
Is it followed?
Is there SOP for cleaning of Toilets and Wash
rooms?
Is it following?
Is there any written procedure for attendance?
Is there SOP for Scrap Management and its
disposal procedure?
Is there an appropriate facility for emergency and
medical treatment in case of any accident? Is the
Ambulance available around the clock?
Is all scrap stored as per designated place with
proper labeling?
8. Pest Control:
Does the contract for Pest Control given to any
Authorized Party?
Are the persons trained?
Does any list of Approved Pesticides available?
Are the Pesticides used are approved?
Is the activity monitored by Security & HRA
Personnel?
Does there any record for Pest Control?
Is it satisfactory?
Is the Air Curtain installed at the entry of
Production Area?

Signature
Date
Pharmacist

Space for Space for

f
Controlled Master

Checklist No.: SI/010/1.0 Engineering Department Audit Report No.:
(Water, HVAC, Utilities and
Preventive Maintenance)

No.
1. SOPs:
Is a complete index and a complete set of applicable SOPs
available in the department?
index?
Obsolete documents removed the Department.
Select three employees working in the department. Are
their training records up-to-date?
1._______________ 2._______________
3.________________
 GMP
 SOPs
 Maintenance techniques
functions?
gowning SOP?

Signature
Date
Pharmacist


No.
Any written procedure are available for personnel hygiene
Select One employee working in the Engineering
department and check his for hygienic condition.
1. ___________
3. Calibration Records:
Is there an approved list of instrumentation included in
the calibration program?
Is the instrument classification (critical, process control,
reference) indicated on the list?
Is there an approved annual calibration planner?
Is there a tracking procedure in place to ensure that every
instrument included in the program actually undergoes
preventive maintenance on time?
Are there written SOPs describing in detail how to
perform calibrations?
Is there a written procedure in place for informing the
relevant QA and production personnel of instruments that
have not undergone calibration according to schedule?
Are traceable calibration standards employed?
Traceable to which agency?
_______________________________________________
Are there certificates of calibration available for the
standards?
Is there a written procedure for corrective action in the
event that the calibration standard is found to be out-of-
limits during re-calibration?

Signature
Date
Pharmacist


No.
Are the standard instruments stored in a manner that
ensures their integrity and accuracy? Physically verify the
storage and condition of three reference standard.
Examine the calibration history of three critical
instruments.
Is there written evidence that the calibration standard
used were within calibration?
Were the instruments calibrated according to the
frequency indicated in the relevant SOP?
In the event that the frequency was not adhered to, is
there written authorization from Quality Assurance?
Were the calibrations performed exactly as defined in the
relevant procedure?
Are the formats completely and accurately filled in?
Were all the calibrations within the defined limits of
accuracy?
If the calibrations were outside the limits, were QA and
production personnel informed immediately in writing?
4. Preventative Maintenance Records:
Is there an approved annual preventative maintenance
program?
Are there written procedure for preventative
maintenance for all production equipment?
preventative maintenance history?
Is there written evidence for each machine that the
preventive maintenance was performed in accordance
with the relevant SOP?
5. Breakdown Maintenance Records:
Is there a record of breakdown maintenance for each
piece of production equipment?

Signature
Date
Pharmacist


No.
Is there a procedure whereby breakdowns are analyzed so
that, if appropriate, the preventative maintenance
program is revised to prevent recurrence?
6. Lubricants:
Is there an approved list of food Grade Lubricants for use
where they may contact product?
Is there a written procedure for the receipt and approval
of such lubricants?
Is a record made of the catalogue number of the lubricant
used when maintenance is performed?
7. Equipment Qualification:
Is there an approved annual for the qualification of all
production equipment?
DQ/IQ/OQ/PQ protocols.
Physically verify that all instruments found on the
equipment are included in the protocols.
Cross-check with the calibration records that the
equipment items have the same classification the
qualification protocol as in the calibration report.
Are the qualification reports approved by all appropriate
personnel?
8. Drawings:
Is there a complete set of approved drawings for facility
Select three equipment items/systems and examine the
available drawings.
Are the drawings the latest edition?
Are the drawings QA approved?
9. Receipt of New Equipment:
Is there an SOP describing the receipt and checking of
new equipment prior to installation?

Signature
Date
Pharmacist


No.
Is there documented evidence that the procedure is
adhered to?
Does the SOP require checking of the equipment
according to approved purchasing specifications?
10. HVAC System:
Is there an SOP for operation, cleaning and maintenance
of HVAC System?
If SOP followed?
If Preventive maintenance planner is available and
followed?
If filter cleaning area is suitable for filter cleaning?
Is filter cleaning records are maintained according to SOP?
Is there an SOP for performing HEPA Filter Integrity Tests?
Is the procedure adhered to?
Examine records of the most recent tests performed.
Is there written evidence of corrective action in the event
that a filter fails the test?
Was the Quality Assurance Department informed of the
failure?
Is the report approved by the Quality Assurance
Department?
Is pressure differential across the HEPA filter is
monitored?
Records are available for the same.
11. ETP System:
Is written procedure available for ETP plant?
Is all documents related to ETP completed with up to
date?
Is preventive maintenance of ETP done as per given
schedule?
Is TSS, BOD & COD test perform as per given frequency
and completeness of document?
12. Water System:

Signature
Date
Pharmacist


No.
12 Is the Air Curtain installed at the entry of Water System?
Is the Air Curtain found in Working Condition?
a) When the Raw Water Holding Tank was last sanitized?
___________________________________________
Is this recorded and is it in accordance with the relevant
SOP?
When the Softener Columns was last regenerated?
__________________________________.
Check the Hardness of the Soft Water.
When the Purified Water Production System was last
sanitized?_______________________________________
Was it in conformance with the relevant SOP?
Check the readings of the following parameters for the
Purified Water Storage and Distribution System.
 Pump pressure:
1. Conductivity on the Supply Line:
2. Conductivity on the Return Line:
Do they conform to the limits stated in the relevant SOP?
Examine the records for the replacement of the air-vent
filter on the Purified Water Tank. Does the frequency
conform to that stated in the relevant SOP?
Are User Points well maintained, with Flexible Tubing
stored in such a way as to minimize contamination?
b) System Operating Records:
Examine the Daily Checklist for the Water System for two
months preceding the audit.
Have they been completed on a daily basis?
Are they approved by Quality Assurance?
If any faults or breakdowns in the system were noted, was
an unusual events reports form completed and
distributed to concerned personnel?
c) System Maintenance Records:

Signature
Date
Pharmacist


No.
Examine records of performance of Preventive
Maintenance.
Do they include the following?
 Changing of air-vent filters on Storage Tanks according
to the frequency in the relevant SOP.
 Cleaning and Sanitation of the Raw Water Storage
Tank
 Cleaning and Sanitation of the RO Water Storage Tank
 Other Storage Tanks Cleaning and Sanitation
 Cleaning and Sanitation of the Purified Water/Highly
Purified water Storage and Distribution System.
 Calibration of All Instrumentation.
d) System Monitoring Records:

Is the System sampled according to the frequency stated
in the SOP?
Is sampling performed at all locations stated in the SOP?
Do results conform to the limits stated in the SOP?
When out-of-limit results were obtained, was Corrective
Action implemented in accordance with the SOP?
What is the overall picture of the state of control of the
Purified Water System?
_______________________________________________
Space for Space for

f
Controlled Master

Checklist No.: SI/011/1.0 Stores Department Audit Report No.:
(Stores & Dispensing)

Signature
Date
Pharmacist


No.
1. SOPs:
Is a Complete Index and a Complete Set of Applicable
SOPs available in the Area?
Are the Index and the SOPs current?
Is the Set of SOPs correctly organized according to the
index?
Are the Obsolete Documents removed from the
Department?
Select three Employees Working in the Area. Are their
Training Records up-to-date?
1.___________________2.____________________
3.________________________
Have the Employees undergone Training in the
 GMP
 SOPs
 Warehouse/Weighing Techniques
are performing.
Are they knowledgeable about their Job Functions?
Gowning SOP, including, where necessary, Masks,
Gloves and Beard covers?
hygiene
Select One employee working in the store Section and
1. ___________

Signature
Date
Pharmacist


No.
3. Facilities:
Is access to the Department restricted to Authorized
Personnel only?
Are the materials stored in separate areas according to
status?
Is the Department maintained in a good state of
repair?
Is there any sign of Pest Activity?
Is the Department neat and orderly with sufficient
space for dispensing of material?
Is there adequate physical separation between
different operations to prevent Mix-Ups and/or Cross–
Contamination?
Is there an SOP describing precautions to be taken
when weighing narcotic drugs, including cleaning
procedures after weighing?
Is there an SOP for monitoring the Temperature and
the Relative Humidity in the Department
Is there documented evidence that it is followed?
4. Cleaning Procedure:
Are there written procedures for cleaning the Stores
and Racks?
Is there documented evidence that the Cleaning
Procedures are being followed?
5. Store Procedure:
Is there an SOP describing the receipt of components
and the examination to be done? Is the examination
documented?
Where a shipment contains more than one batch, is
each batch tested and released separately?
In the event that containers are damaged, does the
SOP specify the Corrective Action to be taken? Is there
documented evidence that the SOP is followed?

Signature
Date
Pharmacist


No.
Are containers of Raw Materials cleaned externally on
receipt? Is cleaning in accordance with a written SOP?
Is the Temperature of the Refrigerator monitored
according to an SOP?
What Corrective Action is required in the event that
the Temperature is Out-of –Limits?
____________________________________________
____________________________________________
Can materials be located easily within the stores
according to the assigned location?
Are all items in the stores labeled as to their status?
Have all items designated released been tested and if
necessary, retested according to an Approved SOP?
Is there a Separate Area for the Storage of Rejected
Materials?
Is there a Separate Area for the Storage of Materials
whose disposition has not yet been decided?
Is stock rotated according to the FEFO Rule? Is this
required by an SOP?
Where the FEFO Rule is deviated? Is there written
justification of the Deviation?
____________________________________________
6. Printed Packaging Materials:
Are all Printed Packaging Materials stored in a
Restricted Access Area?
Are Printed Packaging Materials of different Product,
Strengths, Dosage Form, or Quantity of Contents
stored separately?
Is there an SOP for checking the accuracy of the
balance used for dispensing of packing materials?

Signature
Date
Pharmacist


No.
Examine records of these checks.
 Are they performed according to the frequency
shown in the SOP?
 Where necessary, has appropriate corrective
action been implemented?
Is there an SOP describing the dispensing and control
of printed packaging materials?
7. Finished Goods Store:
Are the Finished Goods awaiting release stored in a
Separate Area from Raw Materials?
Is there an SOP describing the process for dealing with
Returned Goods?
Is there an area in the stores assigned for the Storage
of Returned Goods until their disposition is known?
Is written procedure available for dispatch of finished
product?
Is pre dispatch checklist available ?
Is all documents completed and available for dispatch
of products?
Check the agreement with transporter and validity of
agreement.
8. Sampling Procedure:
Examine the Status Board of the Sampling Booth. Is
the material currently being sampled recorded on it?
Select one of the Raw Materials currently under
Quarantine. Is the material recorded as having been
sampled?
Is there an SOP describing Sampling Operations,
including a Sampling Plan?
Is the Sampling Booth clean?
Watch a Sampling Operation?
Is the Dust Collection System Operational?
Is the Sampler appropriately attired?

Signature
Date
Pharmacist


No.
Are the containers that are to be sampled clean of
External Dust and Powder?
Is sampling equipment stored in a manner to prevent
its contamination?
9. Weighing Procedure:
Are all Instruments in the Department labeled with a
Valid Calibration Tags?
Is there an SOP requiring the inspection of the area for
cleanliness prior to and at the end of dispensing
operations?
Is the operation documented on the Status Board?
Examine the record of the daily check of Balances in
the Department.
 Is it complete and accurately filled out?
 Are all results within the specifications?
 If not, is there a record of the implementation of
corrective action?
Perform a visual examination of the Weights used for
the check.
 Are they in a good state of repair?
 Do they bear a Valid Calibration Tag?
Is there an SOP describing Weighing Operations?
Does it require verification of vendor Tare Weights?
Watch a Weighing Operation being performed.
Is all documentation filled in up to the ingredient being
weighed?
Is the weighed appropriately attired?
Is all equipment used clean at the start of the
operation?
10. Transportation of Medicine And Intermediate:
Are procedure available for the transportation of
Medicine And Intermediate?

Signature
Date
Pharmacist


No.
Is there documented evidence that the Procedures are
being followed?
Is Storage condition chart for raw and finished goods
Is there documented evidence that the storage
condition is maintained throughout the transportation
Space for Space for

f
Controlled Master

Checklist No.: SI/012/1.0 IT Department Audit Report No.:
(Computerized System including Software used by
Stores, Engineering, Production, QA and QC)

No.
1. Stores and Engineering:
Does the Software Validated & Qualified?
Check records. Are they Satisfactory?
Does the systems are protected with Password?
Does a person handling the system trained?
Does a person handling the software trained?
Does their Training Reports available?
Do they have the Back-up System?
Is the data recoverable?
Does there any SOP which includes Start & Shut
Down, access rights method of the computer /
Software?
2. Production:
Check records. Are they Satisfactory?
Does the Systems are Protected with Password?

Signature
Date
Pharmacist


No.
Does a Person Handling the System Trained?
Does their Training Reports Available?
Is the data recoverable?
Down, access rights method of the computer/
Software?
3. Quality Control and Quality Assurance:
Check Records. Are they Satisfactory?
Does the Systems are Protected with Password?
Does a person Handling the System Trained?
Does their Training Reports available?
Is the data Recoverable?
Down, access rights method of the computer/
Software?
4. Documentation:
Is proper documentation available for the all-
computer system and other related
equipment/instrument
Is computer system validation available
Is preventive maintenance of all computer done
as per given schedule
5. Others:
Is Online data backup available
Is there any written procedure for data backup
available

Signature
Date
Pharmacist


No.
Is online data backup available as per define
frequency
Is system data backup procedure follow as per
written procedure
Is data captured from the server is stored in safe
and secure manner
Privilege of the quality control
instrument/equipment’s is defined?
It is follow as per written procedure
Check one instrument/equipment as a
reference________________

Signature
Date
Pharmacist

Space for Space for

F
Controlled Master

Checklist No.: SI/013/1.0 Blending/ Mixing Area Audit Report No.:

No.
1. SOPs:
A complete set of applicable SOPs available in the
Section?
Are Obsolete documents removed from the Mixing Area
Section?
Select One employee working in the Mixing Area
Section. Are their Training Records Available? Is the
Training Matrix updated?
1. ___________
 cGMP
 SOPs
 Blending/ Mixing Techniques
functions?
gowning SOP?
hygiene
hygienic condition as per SOP?

Signature
Date
Pharmacist


No.
Select One employee working in the Blending Section
1. ___________
3. Facilities:
Is the Mixing Area maintained in a good state of repair?
Is the Mixing Area neat and clean with sufficient space
a pallet?
Where more than one pallet is designated for one batch,
is each pallet clearly labeled as one of the total number
of pallets?
condition?
Are all work areas clearly labeled with the name and the
Batch Number of the product being Processed and
Signature of the Production Officer?
Is the Temperature and Relative Humidity maintained in
the Area?
(Observed: Temp. _______,Relative Humidity: _____)
including Shoes?
Change Over?
What is the quality of the air in the Granulation Section
(filter designation)?
____________________________________________

Signature
Date
Pharmacist


No.
5. Equipment and Facility Cleaning And Sanitation:
surfaces are not reactive or absorptive, so that it will not
contaminate or in any way affect the product being
manufactured?
equipment items?
* Machine Log Book
* Cleaning Log Book
Maintenance SOPs)
Do cleaning procedures specify the detergent type and
Is there a written procedure for washing the Mixing
tanks/ Blender

Signature
Date
Pharmacist


No.
processed.
Product:_______________ Batch No.: ____________

Is all materials / items are kept on designated place with
Is the BMR used for this batch is control copy of the
master?
Is the blend properly labeled?
Is there an SOP defining the maximum storage period of
blend stand prior to compression?
Is it adhered to?
Do yield calculations after Mixing conform to the
relevant SOP?
Is yield calculation performed after each distinct phase
of Production?
 Granulation
 Blending
 Mixing
Is there written procedure for Handling of Breakdown of
Equipment and System?
products?
intermediate product?

Signature
Date
Pharmacist


No.
Is it properly recorded?
Is there a record of checking the sieves and screens
before and after use for signs of damage?
production equipment/instrument?
1. ___________2. _______________3. ___________
Reports?
filters?
______________________________________________
______________________________________________
8. Labels:

Signature
Date
Pharmacist


No.
9. Documentation:
been Displayed?
Is any Obsolete Copy seen in the Granulation Section?
qualification and validation of all granulating
equipments?
Select one Vibro Sifter, RMG, FBD, Blender and Mill and
Number?
At last Page of the checklist:
Note:
a) 1 acceptable, 2 Not Acceptable, 3 denote Not applicable.
b) Put √ mark on the column 1, 2, 3.
Conclusion:
Based on Self Inspection Checklist, …………….. has been audited for compliance with organizational
procedure and as per GMP guidelines.
Corrective Action and Preventive Action (CAPA): Required Not Required

If required, attached Non-conformance report for compliance
Audited By:
Signature
Date

Signature
Date
Pharmacist

Name
Designati
on
Departme
nt
ANNEXURE-IV
Header:
Space for
F
Controlled
QUALITY ASSURANCE DEPARTMENT Copy Stamp
SELF INSPECTION NON-CONFORMANCE & COMPLIANCE REPORT

Department Name: Date of Inspection: Audit Report No.:
Body:
S. #Detail of Non- Recommendation Category Corrective and CAPA Verification
No. Conformances s# (C/M/ Preventive Action Plan Actual Date Compliance
N)*# with Targeted Date of of Verified By QA
completion Compliance (Sign & Date)
(To be filled by Auditee
Department
* C = Critical, M= Major, M= Minor

#To be filled by inspector
S. No. Previous Self Inspection Observation from Observation Status If not closed Remarks
Department Closed Not Closed give reason (if any)
On Last Page of the report:

Inspected By:
Lead Auditor Head Auditee Audit Compliance
Closed By Head QA
Signature
Date

Signature
Date
Pharmacist

Name
Designation
ANNEXURE-V
Space for Space for

F

JUSTIFICATION FORM FOR DELAY SELF INSPECTION COMPLIANCE
Self Inspection Report No.: Date of Inspection:
Activity to be completed:
Targeted Date of completion:
Reason for Delay:
Next Targeted Date of Completion:
Initiated By Checked By Approved By

Officer/Executive HOD Head QA
Sign & Date Sign & Date Sign & Date

Signature
Date
Pharmacist

Format No.: COSPHARM/QAD/011/F05-00
ANNEXURE-VI
Space for
F
Controlled Copy
QUALITY ASSURANCE DEPARTMENT Stamp
SELF INSPECTION NOTIFICATION AND EXECUTION RECORD
To,
Head-Auditee Department (Mention Department Name)
Planned Date of Self Inspection: __________________ (Schedule Agreed/To be re-scheduled)
If to be re-scheduled then proposed Date by Head – Auditee Department: ___________
Reason for re-scheduling: _________________________________________________
Sign of Head-Auditee: __________________ Date: _____________
Auditor(s) Details: (To be filled by Lead Auditor)
S. Name Departmen Designatio Signature Remarks with

No. t n (On the Date of sign & Date By
Inspection Lead Auditor (if
Execution)
any)

Signature
Date
Pharmacist

Auditee Details: (To be filled by Head – Auditee Department)
S. No. Name Designation Signature Remarks with

(On the Date of Sign & Date By
Inspection Execution) Head- Auditee
(if any)
From
Head-QA/Lead Auditor Date:
CC: Inspection Team Member
INSPECTION EXECUTION DETAILS
Area Inspected : __________________________Inspection Time: _______________
Execution Date of Inspection: ___________________
Sign: Sign:
Date: Date:
Lead Auditor Head Auditee

Signature
Date
Pharmacist

ANNEXURE-VII
Space for Space for

F

SELF INSPECTION TEAM
Year: Revision No.:

Effective Date: Review Date:
S. No. Name of Departme Designati Lead Team Remark

Approved nt on Auditor* Member* s
Auditor (if any)
* Mention, wherever applicable.

Signature
Date
Name
Designation
Department Quality Assurance Quality Assurance Quality Assurance
Format No:COSPHARM/G/ QAD/010/F07-00
ANNEXURE-VIII
SELF INPSECTION REVIEW REPORT AND TREND ANALYSIS

QUALITY ASSURANCE DEPARTMENT

Signature
Date
Pharmacist

SELF INPSECTION REVIEW REPORT AND TREND ANALYSIS
Review Frequency:
Year: Period from …………. To …………..
S. No. Department Self Category Area of Observation CAPA Current
Inspection (Critical/ Implemented Status
Report No. Major/ M MT S MC D P O Yes No* Open/
Minor ) Closed
1.
2.
3.
Where, M: Men, MT: Material, S: System, MC: Instrument, Equipment & Machine, D: Document, P: Product & O: Others
*If no, provide the reason/justification
Self Inspection Trend chart
Category Self Category Status

Inspection
Critical Major Minor Open Closed
Report No.
Men
Material
System
Machine
Document
Product
Others
Total

Signature
Date
Pharmacist

Trend Chart of Self Inpsection

Month to Month- Year
Number of Observation
Area of Observation
Summary of Review Self Inspection:
Action Plan (In case of incompletion of any Observation):

Self Inspection report No. Recommended Action Target Date of Completion Responsibility
Conclusion:
Recommendation/Area of Improvement (if any):
Prepared By: Checked By: Approved By:

Officer QA Validation Pharmacist QA Pharmacist
Sign & Date Sign & Date Sign & Date
Format No. COS/QAD/010/F08-01
ANNEXURE IX

Signature
Date
Pharmacist

Gemba Walk Observation Tracking Record
S.No Observation Date Action Preventative Date Closed Remarks(If

Taken Measure Any)
ANNEXURE X
GEMBA WALK NON CONFORMANCE FORM
DOCUMENT NO : ________________
DATE : ________________ DEPARTMENT: _____________
Observation
Action(s) Taken

Signature
Date
Pharmacist

Preventative Measure
Evidence attached: YES /NO/Not Applicable
Prepared by (QA): Received by: Department HOD:

________________ _________________ _______________
Sign and date: Sign and date: Sign and date:
________________ _________________ ________________
Remarks (If Any) to be filled by QA:

__________________________________________________________________________
__________________________________________________________________________
__
QA HOD Sign and date: _______________________
COS/QAD/010/F10-01

Signature
Date
Pharmacist

QAD-010 - Self Inspection

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QAD-010 - Self Inspection

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STANDARD OPERATING PROCEDURE

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

To lay down a procedure for self-inspection.

QA Pharmacist and respective department Head

5.1 Preparation & Distribution of Self Inspection Calendar:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

5.2 Selection of Self Inspection Team:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

5.2.3.4 Plant and validation engineer -Team Member

5.3 Auditing Criteria:

5.4 Training of Self Inspection Members:

5.5 Self-Inspection Planning & Execution:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

5.5.13.15 Transportation of Medicine And Intermediate

S. No. Department Name Section Checklist No.

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

S. No. Department Name Section Checklist No.

5.6.1 Numbering System of Checklist:

5.7 Audit Report Numbering System:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

ITD Information Technology

5.8 Preparation of Self Inspection & Compliance Report:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

5.8.1 After completion of Self Inspection, QA Pharmacist/Lead Auditor or his/her designee

5.9 Self-Inspection Review and Trending:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

5.9.1 Continue verification of self-inspection observation with implemented CAPA shall be

7.0 SAFETY PRECAUTION:

SOP : Standard Operating Procedure

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

CGMP : Current Good Manufacturing practices

9.0 SOP DISTRIBUTION:

10.0 CROSS REFERENCE SOP (S):

S. No. Cross reference SOP No.

11.0 CHANGE HISTORY:

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Revision Effective Details of Change Reason For

01 14/10/20 Added QA and CNF/074/2023 Periodic SOP

 PIC/S (PE 009-13)

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Controlled Master Copy

SELF INSPECTION PLANNER AND EXECUTION RECORD

Prepared Checked By Approved By

Format No: COS/QAD/010/F01-01 Page No. X of Y

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Space for Space for

Controlled Master Copy

SELF INSPECTION RECORD

Format No: COS/QAD/010/F02-01

Prepared By Checked By Approved By

Title: Procedure for Self-Inspection SOP No. COS/QAD/010

Product:___ Batch No.:

Product Name: , Batch No.: