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Internal Audit (Self Inspection)

Checklist
 pharmabeginers -  November 23, 2019 -
Internal Audit (Self Inspection) checklist for various departments of
Pharmaceuticals like Quality Control, Quality Assurance,
Production, HR and EHS etc.

Below Internal Audit (Self Inspection) checklist being used for the assessment of respective
departments . these are the minimum requirement for the compliance. It would be the agenda
of Internal Audit (Self Inspection) checklist.
 Copy the SOP from here

Below listed Formats and Checklist for Self Inspection (Internal Audit) are being attached..

Internal Audit (Self Inspection) checklist and formats

Schedule (Annexure – 1)
Internal Audit (Self Inspection) checklist Intimation Form (Annexure – 2)
Execution Form (Annexure – 3)
Internal Audit (Self Inspection) checklist Observation Report (Annexure – 4)
Compliance cum Closing Report (Annexure – 5)
Checklist (Annexure – 6)

Also read: SOP for Audit Trail Review and Privilege

Policy Internal Audit (Self Inspection) checklist Warehouse Checklist (Annexure – 7)

Manufacturing Checklist (Annexure – 8)
Packing Checklist (Annexure – 9)
Internal Audit (Self Inspection) checklist Quality Control Checklist (Annexure – 10)
Engineering/Utilities Checklist (Annexure – 11)
Personnel & Administration Checklist (Annexure – 12)
Internal Audit (Self Inspection) checklist Quality Assurance Checklist (Annexure – 13)

For the SOP on Self Inspection and Internal Audit : click here

Schedule : Internal Audit (Self Inspection)

SOP : SOP on Internal Audit and Self Inspection, Annexure – 1 Page 1 of 1

Year:____________

Sr. No. Name of the department/sections to be audited Date of Audit

Intimation Form : Internal Audit (Self Inspection)

SOP : SOP on Internal Audit and Self Inspection, Annexure – 2 Page 1 of 1

Audit Objective:

Audit Agenda:

From: (Name) To:

(Name)

Department: Quality Assurance Department:

Date of Audit: Internal Audit (Self-

Inspection) No:
 Sr. No. Name of auditors Designation Department

Also read: SOP for Change Control

Management

Date of Audit: (Agreed/Not Agreed) (By Auditee

Dept. Head)

Proposed date of audit : (By

Auditee Dept. Head)

Reason

Authorization of Rescheduled Quality Head

Date of Audit
QA Head (Sign & Date) (Sign & Date)

QA Comments: (Accepted / Not Accepted)

Remarks: Reason for rescheduling of the audit shall be justified & authorized by QA Head.

Execution Form: Internal Audit (Self

Inspection)

SOP: SOP on Internal Audit and Self Inspection, Annexure – 3 Page 1 of 1

 Internal Audit Date of Internal
(Self-Inspection) Audit:
No:

Type: Scheduled/Unscheduled Reason:

Name (Head of Name (Head of

Auditors) Auditee):

Auditor Details Auditee Details

Name Department Sign & Date Name Department Sign &

Date

Observation Report – Internal Audit (Self Inspection)

Checklist

SOP : SOP on Internal Audit and Self Inspection, Annexure – 4 Page X of Y

Audit Agenda

Date of Audit:

Internal Audit (Self-inspection) No:

 Observation No: Observation Classification

Response Timeline: 30 calendar days from the date of receipt of audit observation report.
Compliance to the critical observations shall be done or addressed within
5 working days.

Internal Audit Compliance cum Closing Report

SOP : SOP on Internal Audit and Self Inspection, Annexure – 5 Page X of Y

Audit

Agenda Date

of Audit:

Internal Audit (Self-inspection) No:

Observation No: Observation Classification

Reference
Document /Product

Response Timeline: 30 calendar days from the date of receipt of audit observation report.

Compliance to the critical observations shall be done or addressed within 5

working days.

Internal Audit (Self Inspection) checklist

Target Completion
Responsible Person:

Reference
Document for
compliance

Compliance Status: (Open/Closed)

Compliance Status Checked By

Head of Auditee (Sign& Date):

Auditee Department Head (Sign& Date):

Head of Auditors (Sign& Date):

All actions for Compliance completed Yes / No Tick (√) wherever

applicable

Status of Internal Audit Closing cum

compliance report

Internal Audit (Self Inspection) Checklist

(Annexure – 6)

Internal Audit (Self Inspection) Checklist

A. SOP

1 SOP Index

2 Availability of current version of the SOP

4 SOP compliance

5 Records and logbooks

B. Personnel

1 Availability of Job Description

2 Job description are supported by training records

3 Awareness regarding cGMP

4 Awareness regarding personnel health & hygiene practices

5 Entry and exit procedure

6 Awareness regarding the current job

C. Departmental Activity

1 Availability of approved procedure/ specification

2 Compliance of procedures

3 Awareness of the activity to the concern person.

4 Training records of personnel

5 Calibration status of instruments/equipment used in departments

6 Qualification status of equipment

7 Establishment / Validation of procedure & process

8 Usage of equipment

9 Cleaning and sanitation of areas & equipment

10 Handling of materials & material status & material movement

11 Storage condition of starting and packing materials including management of labels.

12 Man movement & entry/exit procedures

13 Authorization/ Job responsibility/ accountability for specific activity

14 Raw data management like BMR, BPR, Analytical reports

16 Environmental monitoring

17 Handling of intermediates/ finished goods/ process waste/ recoverable/ non recoverable

etc.

18 Safety measures and use of PPEs

19 Mix up, contamination & cross-contamination chances

20 Protection: personnel, product & environment

21 Pest/rodent controls etc.

22 Other GMP/GLP etc. practices as applicable to the department.

D. Quality System check points

1 Personnel

2 Premises including personnel facilities.

3 Maintenance of building and equipment.

4 Storage of materials and finished products

5 Equipment

6 Production and in process control

7 Quality control (RM/PM/FP/Micro/Stability/Validation/GLP)

8 Documentation & its control

9 Sanitation and Hygiene

11 Calibration of instruments or measuring systems

12 Recall procedures

13 Complaints management

14 Label control

15 Results of previous self Inspection any corrective steps taken.

16 Disposal of waste

17 Quality Risk Management

18 Evaluation and approval of suppliers & Vendor qualification and its documents

19 Site Master File

21 Validation Master Plan

22 Validation activities against plan

23 Qualification activities against plan

24 Batch Release system

25 Annual Product Quality Review

26 Control Sample management

27 Handling of Event/Observations

28 Change control Management

29 Implementation and evaluation of CAPA

30 Handling of OOS

31 Handling of OOT

32 Management of Stability Studies

33 Rejections handling
 34 Regulatory compliance

35 Previous Self Inspection reports and Follow ups for closure

E. Safety check points

1 Electrical / Civil / mechanical / Environment / Personnel safety

2 Good maintenance status regarding area, buildings, equipments. (Cracks, paints,

floor, ceiling coving, door, windows, alarm systems etc.)

Internal Audit (Self Inspection) checklist

Remarks:

Auditors shall read the above check points (Checklist) to make themselves aware regarding the scope
of the audit before conducting the internal audit (self inspection) for a particular department /
section / area / system. Internal Audit (Self Inspection) checklist.

Auditors may go to the further depth during execution of self Inspection as per the requirement.

Internal Audit (Self-Inspection) Checklist for Warehouse (Annexure – 7)

Sr. No. Requirements

A. SOP

1 Is a complete index and a complete set of applicable SOPs available in

the department?

2 – The index and the SOP’s current?

3 – The of SOP’s available at the respective places?

B. Personnel

1 Are their training records of the employees working in the department up-to-date?
 2 Have the employees undergone training in the following areas?

GMP

SOP’s

Warehouse / Weighing techniques

3 Question several employees about the operations they are performing.

They knowledgeable about their job functions?

4 All employees following the garmenting SOP, including, where necessary,

masks, gloves, and beard covers?

C. Facilities

1 Materials stored in separate areas according to status?

2 Different materials and different batches of the same material stored on

separate pallets to prevent mix-ups?

3 The department maintained in a good state of repair?

4 Is the department neat and orderly with sufficient space for equipment and
operations?

5 Where appropriate, are all work areas clearly labelled with the name and the batch
number of the product being processed?

6 Is there adequate physical separation between different operations to prevent

mix- ups and / or Cross- – Contamination?

D. Cleaning

1 Are there written procedures for cleaning the warehouse and dispensing room?
 2 Is there documented evidence that the cleaning procedures are being followed?

3 There a written procedure for cleaning the dispensing room?

Between batches of the same

product? Between batches of different

products?

E. General

1 Is there a valid calibration tag affixed to equipment?

2 There an SOP describing the receipt of components and the Examination to be

done? Is the examination documented?

3 Where a shipment contains more than one batch, is each batch tested and
released separately?

4 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?

5 Are containers of raw materials cleaned externally on receipt? Is cleaning in

accordance with a written SOP?

6 Can materials be located easily within the warehouse according to the

assigned location?

7 Are all items in the warehouse labeled as to their status?

8 Have all items designated released been tested and, if necessary, retested according
to an approved SOP?

9 Is there a separate area for the storage of rejected and recalled materials?

Other Checkpoints

10 Is stock rotated according to the FEFO rule?

 11 Where the FEFO rule is deviated from? Is there written justification of the deviation?

12 Is access to the printed packing material area restricted to authorized personnel?

13 All printed packaging materials stored in a restricted access area?

14 Are packaging materials of different product, strengths, dosage form, or quantity

of contents stored separately?

15 All instrumentation in the department labeled with a valid calibration tag?

16 There an SOP for checking the accuracy of the balance used for dispensing
of packaging material?

17 Examine records of these checks.

Are they performed according to the frequency shown in the SOP?

Where necessary, has appropriate corrective action been implemented?

18 Is there an SOP describing the dispensing of printed packaging materials?

19 SOP for dispensing additional packaging materials if the quantity initially dispensed
to production was not sufficient?

20 There an SOP for the return of printed packaging materials to the warehouse?

It followed?

The return recorded?

21 There an SOP for the distribution of finished goods after release?

22 Examine the distribution records for products. Are the goods distributed according to
FEFO/FIFO?

F. Sampling

1 Is there an SOP describing sampling operations, including a sampling plan?

2 Examine the status board of the sampling room.

 The material currently being sampled recorded on it?

Is the airflow system operational?

The sampler appropriately

gowned?

Are the containers that are to be sampled clean of external dust and powder?

3 Select one of the raw materials currently under quarantine.

Is the material recorded as having been sampled?

4 Is sampling equipment are stored in a manner to prevent its contamination?

G. Weighing

1 Are all instruments in the department labeled with a valid calibration tags?

2 Is there an SOP requiring the inspection of the area for cleanliness prior to and at
the end of dispensing operations?

3 Is the operation documented on the status board?

4 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?
 7 Is there an SOP describing weighing operations?

Does it require verification of vendor tare weights?

8 Check a weighing operation being performed.

All documentation filled in up to the ingredient being weighed?

The weigher appropriately attired?

All equipment used clean at the start of the operation?

The weighing operation being carried out by two persons (i.e. performed by
Warehouse and checked by Production.)?

9 Examine the staging area for weighed batches. Are all the ingredients for one
batch assembled together?

H. Others

1 How the stock checks inspections is done?

2 How the consumable stocks are maintained?

3 Are the spares parts inventory for the equipment in the area are maintained?

4 Check the inventory management system?

5 Is there an SOP describing the management of the inventories?

I. EHS: Internal Audit (Self Inspection) checklist

J. IT: Internal Audit (Self Inspection) checklist

Internal Audit (Self-Inspection) Manufacturing Checklist (Annexure

– 8)

Requirements

A. SOP
 1 Is a complete index and a complete set of applicable SOPs available in the department?

2 Are the index and the SOP’s current?

3 Are the of SOP’s available at the respective places?

B. Personnel

1 Are training records of the employees working in the department up-to-date?

2 Have the employees undergone training in the following areas?

GMP

SOP’s

Production techniques

3 Question several employees about the operations they are performing.

Are they knowledgeable about their job functions?

4 Are all employees following the garmenting SOP, including, where necessary,
masks, gloves, and beard covers?

C. Facilities

1 Is the department maintained in a good state of repair?

2 Department neat and orderly with sufficient space for equipment and operations?

3 Are all the raw materials for one batch assembled on a pallet?

4 Where more than one pallet is designated for one batch, is each pallet clearly
labeled?

5 Are all work areas clearly labeled with the name and the batch number of the product
being processed?

D. Prevention of Cross-Contamination
 1 Are doors closed at all times?

2 Personnel clothing clean, unstained, and dust free, including foot wares?

3 There a foot ware-cleaning SOP?

4 Pressure differential maintained in working areas at all times during work?

5 There a record of the pressure differential?

6 What is the quality of the air in the department (filter designation)?

7 Are their approved SOP’s for the maintenance of filters?

8 Is dirty equipment covered prior to transfer to the washing room?

E. Equipment and Facility Cleaning

1 Are pallets and drums brought into the clean area are free from powder / dust / dirt?

2 Is the equipment neat, clean, and rust free?

3 When not in use, are equipment covered so as to prevent accidental contamination?

4 Are the equipment suitably designed for its purpose?

5 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?

6 Are the dedicated equipment change parts e.g. FBD filter bag, punch sets, etc. are used
as per the product under manufacturing?

7 Are there specific procedures for the cleaning of major equipment items?

8 Select a major piece of equipment.

Examine the following records:

Status Board
 9 Visually inspect one piece of equipment that is not in use

Is it labeled with respect to its cleanliness status?

Is it clean?

10 Do cleaning procedures include a requirement for the cleaning of

accessories? (e.g., Scoops, FBD bags, gaskets and any other contact parts of

the machine).

11 An approved protocol for cleaning validation?

12 Documented evidence that it is being followed?

13 A written procedure for washing the finger bags of fluid bed dryers?

14 Where compressed air is supplied to machinery, is it oil free and filtered?

15 Is there an SOP for filter replacement?

16 What filtration is provided to incoming air in fluid bed dryers?

17 SOP for the cleaning and replacement of these filters?

18 What measures are taken to prevent cross-contamination of product from these

filters when inlet air is not functioning?

F. Working Procedures

1 Examine the environmental controls in the processing areas i.e. temp.,

humidity, pressure differential. Are these within the specified limits?

2 Examine the record of the daily check of balances in the department.

3 Is it complete and accurately filled out?

4 Are all results within the specifications?

5 If not, is there a record of the implementation of corrective action?

 Are they in a good state of repair?

Do they bear a valid calibration sticker?

7 Examine the batch record for a batch that is being processed.

1. Product:

Batch No.:

8 Is the master formula signed as being an accurate copy of the original?

9 Have any changes to the master formula been authorized by QA?

10 Is the record completely and accurately filled out up to the appropriate stage
of processing?

11 Are all in-process results within the defined limits?

12 Is there a written procedure for the cleaning of drums after use?

13 Examine the in-process storage area.

14 Are the in process material properly labeled?

15 Examine a sample of in process material to be sent to the laboratory for testing.

16 Is it labeled in accordance with the relevant SOP?

17 If not, is corrective action implemented according to the relevant SOP?

18 Do yield calculations conform to the relevant limit?

19 If not, has a BMR been completed and an investigation conducted?

20 There a record of checking the sieve screens after use for signs of damage?

21 SOP for the receipt of punches and dies in the department?

22 Are punches lubricated in the department and, if so, with an approved lubricant?

23 An approved SOP for in-process control?

 24 Does the SOP state at what frequency tests must be performed by Production
personnel?

25 Examine a batch record. Is the test frequency adhered to?

26 Do all test results conform to specifications?

G. Equipment Calibration

1 Select three equipment items and examine the Calibration records.

2 Are the equipment items identified with a distinguishing code number?

3 All critical instrumentation on the equipment items identified with a valid

calibration tag?

4 Physically verify that all instruments found on the equipment items are included
in the Calibration file.

5 Calibrations reports checked by appropriate personnel?

6 Are the reports completely and accurately filled out?

Internal Audit (Self-Inspection) Packing Checklist (Annexure –

9)

Requirements

A. SOP

1 Is a complete index and a complete set of applicable SOPs available in the department?

2 Index and the SOP’s current?

3 Are the of SOP’s available at the respective places?

B. Personnel
 2 Have the employees undergone training in the following areas?

GMP

SOP’s

Packing techniques

3 Question several employees about the operations they are performing.

Are they knowledgeable about their job functions?

4 Are all employees following the gowning SOP, including, where necessary,
masks, gloves, and beard covers?

C. Facilities

1 Is the department maintained in a good state of repair?

2 Neat and orderly with sufficient space for equipment and operations?

3 Are all the packing materials for one batch assembled on a pallet?

4 Where more than one pallet is designated for one batch, is each pallet clearly
labeled?

5 Are all work areas clearly labeled with the name and the batch number of the product
being processed?

6 What is the quality of the air in the department (filter designation)?

7 Are their approved SOP’s for the maintenance of filters?

E. Equipment and Facility Cleaning

1 Pallets and drums brought into the clean area are free from powder / dust / dirt?

2 Is the equipment neat, clean, and rust free?

3 When not in use, are equipment covered so as to prevent accidental contamination?

4 Are the equipment suitably designed for its purpose?

 5 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?

6 Are the dedicated equipment change parts e.g. SS transfer pipes etc. are used as per the
product under manufacturing?

7 Are there specific procedures for the cleaning of major equipment

items?

8 Visually inspect one piece of equipment that is not in use. Is it labeled with respect to
its cleanliness status? Is it clean?

9 Do cleaning procedures include a requirement for the cleaning of

accessories? (e.g., Scoops, gaskets and any other contact parts of the

machine).

10 Approved protocol for cleaning validation?

11 Documented evidence that it is being followed?

12 Where compressed air is supplied to machinery, is it oil free and filtered?

13 Is there an SOP for filter replacement?

F. Working Procedures

1 Examine the environmental controls in the processing areas i.e. temp.,

humidity, pressure differential. Are these within the specified limits?

2 Examine the record of the daily check of balances in the department.

3 Is it complete and accurately filled out?

4 Are all results within the specifications?

5 If not, is there a record of the implementation of corrective action?

6 Perform a visual examination of the weights with which the check is performed.
7 Examine the batch record for a batch that is being processed.

1. Product:

Batch No.:

8 The record completely and accurately filled out up to the appropriate stage
of processing?

9 Are all in-process results within the defined limits?

10 Is there a written procedure for the cleaning of SS containers after use?

11 Examine the in-process storage area.

12 Are the in process material properly labeled?

13 Is there an SOP defining the maximum period of time that in process material may
be stored prior to packing?

14 Examine a sample of in process material to be sent to the laboratory for testing.

15 Is it labeled in accordance with the relevant SOP?

16 Do the in-process assay results for the bulk conform to the relevant SOP?

17 If not, is corrective action implemented according to the relevant SOP?

18 Do yield calculations conform to the relevant SOP?

19 If not, has a BPR been completed and an investigation conducted?

20 SOP for operation and cleaning of filling machine Available ?

21 Availability of SOP for checking for Key activities and challenge tests?

22 Is there a SOP for operation and cleaning of Key packing machine?

23 SOP for Checking for coding/ overprint details on the packs?

24 An approved SOP for in-process control?

 25 Does the SOP state at what frequency tests must be performed by Production
personnel?

26 Examine a batch record. Is the test frequency adhered to?

27 Do all test results conform to specifications?

28 Examine a batch record, for packing material usage and reconciliation detail?

G. Equipment Calibration

1 Select three equipment items and examine the Calibration records.

2 Are the equipment items identified with a distinguishing code number?

3 Is all critical instrumentation on the equipment items identified with a valid

calibration tag?

4 Physically verify that all instruments found on the equipment items are included
in the Calibration file.

5 Are the Calibrations reports checked by appropriate personnel?

6 Are the reports completely and accurately filled out?

H. Routine activity

1 An approved system of material return?

2 Existence of approved system for additional material request?

3 System in place for reconciliation?

4 An approved system for proof check and are documented properly?

5 Is there an approved system for sampling?

6 Sampling details are captured in BPR?

7 Any system to check for attachments/Annexures with the BPR? Is it followed properly?
 8 Are packing instructions are clear?

9 Packing arrangements are clearly mentioned in the BPR?

10 Is there any system to check the FG/ PM / correct batch nos etc. prior to packing?

11 De-foiling activity is recorded and controlled?

12 Overprinting approval is done prior to packing and over printing?

13 Adequate challenge tests are being performed?

14 BPR is reviewed prior to submission to QA for final release?

15 Destruction procedure is in place for each component of rejected FG / PM?

16 Awareness of procedure related to packing among the operator/ supervisor if

adequate?

17 Is there any system to record the discrepancies in respective BPR, if observed

during packing?

18 BPR is adequately prepared to capture all relevant details ?

19 Labeling procedure is adequately followed for all Packing lines/ packing components
etc.?

Quality Control Checklist (Annexure – 10)

Internal Audit (Self Inspection) Checklist Requirements

A. SOP

1 Is a complete index and a complete set of applicable SOPs available in the department?

2 Are the index and the SOP’s current?

3 Are the Annexures current?

B. Personnel
 1 Are the training records of the employees working in the department up-to-date?

2 Have the employees undergone training as

per GDP

GLP

Analytical techniques

3 Are detailed, written job descriptions available for all employees?

C. Facilities

1 Laboratory maintained in a good state of repair?

2 Is the laboratory neat and orderly with sufficient space for equipment and operations?

3 Is the good housekeeping followed?

4 Are all reagents and solutions

Clearly labeled with their proper name?

Labeled with date of receipt and/or expiration date?

5 Are prepared solutions labeled with the

Name of person who prepared them?

Date of preparation?

Expiration date?

6 Is there an SOP for the cleaning and disinfection of the clean room?
 7 There records of the preparation of disinfectants?

8 Disinfectants labeled with expiration dates?

9 Cleaning records available and correctly filled out?

D. Instrumentation and Calibration

1 There an annual maintenance contract for key equipment / instruments used in the
laboratory?

2 Is there evidence that it is followed?

3 Written procedures for operating the instruments?

4 Are there written procedures for calibrating the instruments?

5 Is there a valid calibration sticker on each instrument?

6 Examine the calibration records for the instruments.

Are they up-to-date?

7 Is there an SOP for corrective action in the event that an instrument is found to be out
of calibration?

E. Sample Receipt, Storage, and Documentation

1 Is there a written SOP describing sample receipt and recording?

2 Where are samples stored before and after testing?

3 Are samples retained after completion of testing and reporting? If not, What happens
to samples after testing and reporting are complete?

4 Are the reserve samples kept as per procedure?

F. Test Procedures
 1 Are there approved test procedures available for all tests performed in the
laboratory?

2 Examine the work currently being performed on the HPLCs.

1. Product Name :

Batch No. :

3 Is it up-to-date?

4 Is it being accurately followed?

5 Has the analyst recorded all the relevant details of the product being tested,
including the attachment of printouts of relevant instruments?

6 Is written cleaning procedure available for glassware’s?

7 Laboratory records having name of Product and Batch number?

8 Are laboratory records indicating date of receipt of sample and expiry date?

G. Recording Results

1 Examine an analytical template

2 It neatly filled in and legible?

3 There a record of the instrument used for testing together with any raw data?

4 Are all calculations recorded?

5 Are all charts, graphs, and printouts labeled with the

Product name and batch number?

Date of the test?

6 Are numbers rounded in accordance with an approved SOP?

 7 Do the dates on graphs/charts match with the dates of analysis?

8 Is the analyst’s signature recorded in the template?

9 Are references of Instruments/Equipment’s and volumetric solution used given in the

analytical work sheet?

H. Reference Standards / Working Standards

1 Examine a reference standard.

2 Is it stored appropriately?

3 The standard tested internally to confirm its quality?

4 Is there a written SOP for the preparation of working standards?

5 How often are working standards prepared?

6 Record of the preparation of volumetric solutions?

7 Examine a test where a volumetric solution was used. Was the titer correctly
recorded in the notebook?

I. OOS

1 Is there an SOP for OOS handling

2 Does the SOP describe a procedure for invalidating results?

3 Does the procedure require a written explanation of the reason for the retest?

J. Evaluation of Results

1 Is there an SOP for review of test data and calculations?

2 Raw data reviewed prior to release from the laboratory by a person other than
the analyst who performed the test?

3 Are analytical template routinely reviewed by a supervisor?

I. OOS

1 Is there an SOP for OOS handling

2 SOP describe a procedure for invalidating results?

3 Does the procedure require a written explanation of the reason for the retest?

J. Evaluation of Results

1 Is there an SOP for review of test data and calculations?

2 Are raw data reviewed prior to release from the laboratory by a person other than
the analyst who performed the test?

3 Are analytical template routinely reviewed by a supervisor?

K. Stability study

1 Stability study schedule available?

2 Protocols for all stability study samples available?

3 Does procedure for keeping stability sample available?

4 Stability samples kept as per storage requirement?

5 Are stability summary available?

L. Stock Cultures

1 Is there an SOP for the receipt and handling of American Typed Culture
Collection (ATCC) / National Collection of Typed Culture (NCTC) cultures?

2 Are cultures received with a certificate of analysis?

3 How often are ATCC / NCTC cultures transferred?

4 Identification of master cultures.

M. Environmental and Periodic Monitoring ( Clean Room )

1 Is there an SOP for monitoring differential air pressures?

2 Are there written records of air pressures checked and signed?

3 Is there an SOP for environmental monitoring in the clean room?

4 Do results conform to the limit stated in the SOP?

5 When out-of-limit results were obtained, was corrective action implemented in

accordance with the SOP?

6 Examine records of monitoring for the past three months.

7 Are there records of checking laminar airflow velocities?

8 Are there records of checking air changes?

N. Other Documents

1 Validation of cleaning / use of disinfectants in production areas.

2 Calibration of UV hour meter and intensity check of UV lights on LAF bench and
Pass box.

3 Are the media stocks prepared in accordance to First In First Out (FIFO) rule?

Engineering / Utilities Checklist (Annexure –

11)

Internal Audit (Self Inspection) Checklist Requirements

A. SOP

1 A complete index and a complete set of applicable SOPs available in the department?

2 Are the index and the SOP’s current?

B. Personnel

1 Are training records of the employees working in the department up-to-date?

2 Have the employees undergone training in the following areas?

GMP ,SOP’s and Engineering techniques

3 Question several employees about the operations they are performing. Are
they knowledgeable about their job functions?

4 Are all employees following the garmenting SOP, including, where necessary,
masks, gloves, and beard covers?

C. Calibration Records

1 Are there written procedures which describes calibration process?

2 Is there an approved annual calibration schedule?

3 A tracking procedure in place to ensure that every instrument included in the program
actually undergoes calibration on time?

4 Master list of instruments and calibration procedures available in the area? Are they
maintained and updated?

5 Written SOPs describing in detail how to perform calibrations?

6 Are there certificates of calibration available for the standards?

7 Examine the calibration history of critical instruments.

8 Is there written evidence that the calibration standard used were within calibration?

9 Were the instruments calibrated according to the frequency indicated in the relevant
SOP?

10 Are the calibration reports checked by appropriate personnel?

11 Were the calibrations performed exactly as defined in the relevant procedure?

D. Preventive Maintenance Records

1 Is there an approved annual preventive maintenance program?

2 Written procedures for preventive maintenance for all utility equipment?

3 Are there written records of performance?

4 Examine the preventive maintenance history of equipments?

5 Is there written evidence for each machine that the preventive maintenance was
performed in accordance with the relevant SOP?

6 Is the master list available which identifies that all equipments are included?

7 Are the maintenance manuals, drawings, wiring diagrams and parts list of equipments
under preventive maintenance program?

8 Are all documents properly signed and dated?

E. Breakdown Maintenance Records

1 A record of breakdown maintenance for each piece of production equipment?

F. Equipment Qualification

1 Is there an approved program for the qualification of equipments?

2 Examine the IQ/OQ protocols.

3 Physically verify that all instruments found on the equipment are included in the
protocols.

G. Drawings

1 Is there a complete set of approved drawings for systems and equipment available in
the department?

2 Check equipment items/systems and examine the available drawings.

 3 Are the drawings the latest edition?

4 Is the drawing QA approved?

H. Filter Integrity Test Records

1 An SOP for performing HEPA filter integrity tests?

2 Is the procedure adhered to?

3 Examine records of the most recent tests performed.

4 Is it found in order?

I. Water System

SOPs

1 Is a complete index and a complete set of applicable SOPs available to the system
operator?

2 Are the index and the SOPs current?

Personnel

1 Has the system operator undergone training in

GMP?

SOPs?

2 Are the training records up-to-date?

Walk-Through of System

1 Perform a walk-through inspection of the entire system.

2 Is the general environment clean and tidy for

Potable water storage?

 Purified water production system?

Purified water storage system?

3 Is the system leak free, rust free, and well maintained?

4 Are system controls such as electrical panels and switches protected so as to

prevent accidental tampering?

5 Is access to the main water holding tank for the factory restricted?

6 Are the covers to the main water holding tank locked?

7 When was the main water holding tank last cleaned / sanitized?

8 Is this recorded and is it in accordance with the relevant SOP?

9 When the purified water production system was last sanitized?

10 Was it in conformance with the relevant SOP?

11 Are user points well maintained, with flexible tubing stored in such a way as to
minimize contamination?

System Drawings

1 Is a complete set of up-to-date system drawings available to

The system operator?

Maintenance personnel?

2 If any changes have been made, has the validation file been updated and any
necessary testing performed?

3 Did the results meet the specifications?

System Operating Records

 1 Examine the daily checklists for the water system for two months preceding the audit.

2 Have they been completed on a daily basis?

3 If any faults or breakdowns in the system were noted, was an unusual event. Report
form completed and distributed to concerned personnel?

Maintenance Records

1 Examine records of performance of preventive maintenance.

Do they include the following?

Cleaning and sanitation of the main water holding tank

Purified water production system

Purified water storage system

Monitoring Records

1 The system sampled according to the frequency stated in the SOP?

2 Is sampling performed at all locations stated in the SOP?

3 Do results conform to the limits stated in the SOP?

4 When out-of-limit results were obtained, was corrective action implemented in

accordance with the SOP?

5 What is the overall picture of the state of control of the purified water system?

Validation File

1 Examine the validation file for the purified water system

2 Was the validation performed according to schedule?

 3 Does the report indicate that the system is operating in a repeatable and reliable
manner?

4 Have any non conformity’s with the validation protocol been indicated in the report,
explained, and suitably authorized?

Personnel & Administration Checklist (Annexure – 12)

Internal Audit (Self Inspection) Checklist Requirements

A. SOP

1 Is a complete index and a complete set of applicable SOPs available in the department?

2 Are the index and the SOP’s current?

B. Personnel

1 Are the training records of the employees working in the department up-to-date?

2 Have the employees undergone training in the following areas?

GMP

SOP’s

HR Policies.

3 Question several employees about the operations they are performing. Are
they knowledgeable about their job functions?

4 Is an up-to-date organizational chart of the Personnel Department available?

C. Pest Control

1 An SOP for Pest Control Procedures?

2 Is it followed?
 3 Are all the procedures clearly given for control of all types of pests and

their frequency of control followed

4 Examine recent Pest Control records.

5 Are the records complete with respect to the following?

All relevant signatures are present.

Data are present.

Data are accurate.

Are all the records properly verified by pest control Agency?

D. Other Records

1 Are there a written procedures for the following:

Medical Check up of Employees

Security Services

Canteen Management

Garden Management

2 Examine all the employees Medical Reports.

3 Is there a list available stating the names of employees who have undergone
Pre- employment, routine Medical examination?
 4 Are all the agreements pertaining to the requirement of the Company maintained
properly?

5 Are there procedures for washing and maintenance of lockers?

6 Are the records complete with respect to the following?

Signatures are present.

Data are present.

All relevant data are accurate.

7 Are there procedures for safety and fire fighting available?

8 Enough awareness created by company for maintaining safety and fire fighting?

Training imparted on fire fighting techniques ? Are the records maintained?

Quality Assurance Checklist (Annexure –

13)

Internal Audit (Self Inspection) Checklist Requirements

A. SOP

1 Is a complete index and a complete set of applicable SOPs available in the department?

2 Are the index and the SOP’s current?

B. Personnel

1 Are training records of the employees working in the department up-to-date?

 GMP

SOP’s

QA Procedures

3 Question several employees about the operations they are performing.

Are they knowledgeable about their job functions?

4 Are all employees following the garmenting SOP, including, where necessary,
masks, gloves, and beard covers?

5 Is an up-to-date organizational chart of the Quality Assurance Department

available?

C. Batch Record Review

1 An SOP for batch record review prior to release?

2 A comprehensive checklist for batch record review prior to release?

3 Examine recently released batch records.

1. Product : Batch No.:

2. Product : Batch No.:

3. Product : Batch No.:

4 Are the records complete with respect to the following?

Master formula is signed as true copy.

Any changes to the master formula are QA authorized prior to manufacturing

All relevant signatures are present.

 Relevant data are present.

Data are accurate.

Yield calculation at each stage of production.

Calculations are verified by a second individual.

D. Deviations and Change Control Records

1 Are all changes that may impact product quality authorized by Quality Assurance
prior to implementation? Examine recent deviations and change control records

E. Self-Inspection

1 Self-inspection performed according to the frequency stated in the SOP?

2 Is there written evidence of corrective action implemented as a result of the

inspections?

3 Are all observations of last self-inspection closed with proper corrective action &
preventive action?

F. Complaints

1 Is there an SOP for dealing with complaints?

2 Examine recent complaints.

1. Product :

Batch No.:

2. Product :

Batch No.:

3. Product :
 Batch No.:

3 Do the files contain all the relevant data?

4 Have the files been signed by the relevant personnel?

5 Could any of the above complaints affect other batches of the product and, if so, has
an investigation been initiated and appropriate action taken?

6 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?

G. Rejected Batches

7 Examine the list of rejected batches for the current year. Select three batches.

1. Product :

Batch No.:

2. Product :

Batch No.:

3. Product :

Batch No.:

8 List the reason (s) for the rejection.

9 Specify at which stage of production the batches were rejected.

10 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?

11 Are there any products that have more than one rejected batch and, if so,
has corrective action been recommended and implemented?
H. Recalls

1 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?

2 Have there been any recalls during the current year?

3 List the disposition of the recalled goods.

4 Is the disposition adequately justified with a documented investigation and

conclusions authorized by Quality Assurance?

5 Could the reason for the recall implicate other batches of the product and, if so, has
an investigation been initiated and appropriate action taken

I. Validation

1 A written procedure for carrying out validation of drug products?

2 Master Validation Plan available?

3 Is it followed?

4 Check the validation file of any one of the products being manufactured.

J. Vendor Qualification

1 All the related declarations required for the material available?

2 Is the audit planner for all API available?

3 Audit and compliance report for approved API vendor and primary packing material
vendor available?

4 Are the timelines mentioned in SOP for Audit report and Compliance report followed?

5 Approved vendor list for all raw materials and packing materials available?

K. Others
1 There standard operating procedure for qualification and Validations?

2 Check whether it is followed.

3 Is there standard operating procedure for training?

4 It adhered to?

5 the list of documents available?

6 Are all documents are arranged and maintained properly?

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