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Self Inspection Checklist & Internal Audit Formats

Self Inspection (Internal Audit) Checklist for various departments/systems and functions of the pharmaceutical manufacturing plant. These checklists are applicable for inspection of the Company’s operations directly or indirectly connected with Manufacturing, Stores, Dispensing, Sampling, Packaging, Quality Control, Microbiology, Engineering,  IT, personnel, safety, Documentation, etc.

Self Inspection Checklists

List of Self Inspection (Internal Audit) Checklists –

  1. Stores & Ware House Self -Inspection Checklist
  2. Production (OSD) Self -Inspection Checklist
  3. Engineering Self -Inspection Checklist
  4. Quality Control (Analytical) Self -Inspection Checklist
  5. Quality Assurance Self -Inspection Checklist
  6. Water System Self -Inspection Checklist
  7. Microbiology Self -Inspection Checklist
  8. HR / Administration Self -Inspection Checklist
  9. Production (Oral Liquid) Self -Inspection Checklist
  10. IT Self -Inspection Checklist

Related: SOP for Self Inspection (Internal Audit)

1.0  Inspection checklist – Stores / Ware House.  

MONTH/YEAR: _________________

Section A: Self-Inspection audit information
Sr. No. Particulars Observations
1.0 Date(s) of Audit
2.0 Name of Auditee(s)
3.0 Name of Auditor(s)
4.0 Purpose of Audit Periodic Audit/Special audit for:

Section B: Self-Inspection Checklist

Sr. No.

 Requirements

Remarks

A. SOP
1 Are 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 SOP’s available at the respective places?  

B.  Personnel
1 Is there any written procedure available for training?  
2 Are training records of the employees working in the department up-to-date?  
3 Have the employees undergone training & evaluation in the following areas?

  • cGMP
  • SOP’s
  • Production techniques
  • EU_GMP
  
4 Are several employees knowledgeable about their job functions?  
5. Is there any written procedure available for the gowning system?  
6 Are all employees following the garments SOP, including, where necessary, masks and gloves?  

C.  Receiving Bay: (Self Inspection Checklist)
1.  Is the Air Curtain working properly?  
2. Is the department maintained in a good state of repair?  
3. Is a Vacuum Cleaner available?  Check it for proper functioning.

Is the SOP for operation and cleaning displayed?

  
4. Is the SOP for receipt & handling of materials displayed?  
5. Is there any SOP for describing the receipt of components and the examination? Is the examination documented?  
6. Where a shipment contains more than one batch, is each batch tested and released separately? Check Records.  
7. 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?  
8. Are containers of raw materials cleaned externally on the receipt? Is cleaning in accordance with a written SOP?  
9. Check the balances calibration records as per SOP.  

D. Under Test Area (Self Inspection Checklist)
1 Is the Area is clean as per SOP? Check Record.  
2 Is the Area maintained in a good state of repair?  
3 Are materials stored batch wise / lot wise on separate pellets?  
4 Check two or three products for proper under test label.  

E. Sampling Area: (Self Inspection Checklist)
1 Is the Area is clean as per SOP? Check Record.  
2 Is the Area maintained in a good state of repair?  
3 Is there an SOP describing sampling operations, including a sampling plan?  
4
  • Examine the status board of the sampling room.
  • the material currently being sampled recorded on it?
  • The airflow system is operational.
  • Is the sampler appropriately gowned?
  • Are the containers that are to be sampled clean of external dust and powder?
  
5 Select one of the raw materials currently under quarantine.

Is the material recorded as having been sampled?

  
6 Is sampling equipment is stored in a manner to prevent its contamination?  
7 Check the given below records:

  1. Validation status of RLAF
  2. Balance Calibration
  3. Sampling Records
  4. Temperature & RH of Area

Filter cleaning record

  
8 Is the current SOP for the sampling of RM displayed and followed?  
9 Check two or three products for the proper sampled label.  

F. Approved Areas:
1 Is the Area is clean as per SOP? Check Record.  
2 Is the Area maintained in a good state of repair?  
3 Check the temperature & RH of the area wherever required. Is there any written procedure?  
4 Are different materials and different batches of the same material stored on separate pallets to prevent mix-ups?  
5 Check two or three products for proper labeling i.e. Approved Label.  
6 Can materials be located easily within the stores according to the assigned location?
7 Where appropriate, are all work areas clearly labeled with the name and the batch number of the product being dispensed/sampled?
8 Are all items in the stores labeled as to their status?
9 Have all items designated released been tested and, if necessary, retested according to an approved SOP?
10 Is PM stock rotated according to the FIFO rule?

Is RM stock rotated according to the FIFO / FEFO rule?
11 Where the FIFO rule is deviated from? Is there a written justification for the deviation?
12 Is access to the printed labels are restricted to authorized personnel?
13 Are all printed labels stored in a restricted access area?
14 Are packaging materials of different products, strengths, dosage forms, or quantity of contents stored separately?
15 Is there any SOP for checking the accuracy of the balance used for dispensing of packaging material?

16

Examine the records of these checks.

  • Are they performed according to the frequency shown in the SOP?
  • Where necessary, has appropriate corrective action been implemented?
17 Is there an SOP describing the dispensing of printed packaging materials?
18 Is there any SOP for dispensing additional packaging materials if the quantity initially dispensed to production was not sufficient?
19 Is there any SOP for the return of printed packaging materials to the stores?
20 Are utensils holding time study performed? Comments:

G. Finished Goods Store – Self Inspection Checklist:
1 Is the Area is clean as per SOP? Check Record.
2 Is the Area maintained in a good state of repair?
3 Is there an SOP for the distribution of finished goods after release?
4 Examine the distribution records for products.

Are the goods distributed according to FIFO?
5 Is there a separate area for the storage of rejected and recalled materials?

H. Dispensing – Self Inspection Checklist
1 Is the Area is clean as per SOP? Check Record.
2 Is the Area maintained in a good state of repair?
3 Is there an SOP describing dispensing operations?
4 Examine the status board of the dispensing area.

  • Is the material currently being dispensed recorded on it?
  • The airflow system is operational.
  • Is the person appropriately gowned?
5 Check the given below records:

  1. Validation status of RLAF
  2. Balance Calibration
  3. Dispensing Records
  4. Temperature & RH of Area
  5. Filter cleaning record
  6. Cleaning of dispensing tools
6 Is the dispensed material stored as per the proper status label?
7 Are utensils holding time study performed?

I. Records & Traceability – Self Inspection Checklist
1 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?
  • Check the calibration certificate of weights
2 Check the GRN File for proper filing.

Ask the person to show a two or three-month back record and record the time?
3 Select two or three products and verify the physical stock?
4 Is the list of RM available with storage conditions?

J. Other observation – Self Inspection Checklist :

2.0  Inspection checklist – Production (OSD).  

Sr. No.

 Requirements

Remarks

A. SOP
1 Are a complete index and a complete set of applicable SOPs available in the department?  
2 Is the current version of the SOP index available?  
3 Are the SOP’s available at the respective places?  

B.  Personnel                                                       Related: SOP for Self Inspection (Internal Audit)
1 Is there any written procedure available for training?  
2 Are training records of the employees working in the department up-to-date?  
3 Have the employees undergone training & evaluation in the following areas?

  • cGMP
  • SOP’s
  • Production techniques
  • EU_GMP
  
4 Are several employees knowledgeable about their job functions?  
5 Is there any written procedure available for the gowning system?  
6 Are all employees following the garments SOP, including, where necessary, masks and gloves?  

C.  Facilities – Self Inspection Checklist
1 Is the department maintained in a good state of repair?
2 Is the department neat and orderly with sufficient space for equipment and operations?
3 Are all work areas clearly labeled with the name?
4 Is there any written procedure available for status labeling?
5 Is the area qualified? Have any modification in the facility in the last 6 months?
6 Is a data logger is available in the processing area? Has any excursion recorded in the last 6 months?
7 Is there any written procedure available for recording temperature & % relative humidity?
8 Are the entire area log books updated?

D.  Prevention of Cross-Contamination – Self Inspection Checklist
1 Our doors closed at all times? Do they know the purpose of the airlock?
2 Is there any written procedure for the interlocking system?
3 Is a personnel clothing clean, unstained, and dust-free, including foot wares?
4 Is there any written procedure available for monitoring Deferential pressure?
5 Is pressure differential is maintained in working areas at all times during work?
6 Is the logbook of the pressure differential updated?
7 Is the compressed air & nitrogen air in the area qualified? Have a re-qualification planner?
8 Is there an SOP for the cleaning and replacement of these filters?
9 Is dirty equipment covered prior to transfer to the washing room? Have any written procedures?

E.  Area & Equipment

  • Raw material Day Stores
1 Are pallets and drums brought into the area clean area free from powder/dust/dirt?
2 Is all the material stored on pallets:
3 Is inward & outward log update?
4 Is balance calibrated and log of balance updated?

  • Granulation (Self Inspection Checklist)
1 Is the area & equipment neat, clean, and rust-free?
2 Is the equipment suitably designed for its purpose?
3 Are 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?
4 Is there a machine history card available?
5 Is there a written procedure for the cleaning and operation of the Vibro sifter?
6 Is there a written procedure for the cleaning and operation of RMG?
7 Is there a written procedure for the cleaning and operation of the multi mill?
8 Is there a written procedure for the cleaning and operation of FBD?
9 Is there a written procedure for washing the finger bags of fluid bed dryers?
10 Is there a product dedicated filter bag available?
11 Is the entire equipment log updated?

  • Blending  (Self Inspection Checklist)
1 Is there a written procedure for the cleaning and operation of Bin?
2 Is the entire bin qualified?
3 Is there a written procedure for washing the bin?
4 Is the equipment log updated?

  • Compression (Self Inspection Checklist)
1 Is the area & equipment neat, clean, and rust-free?
2 Is the equipment suitably designed for its purpose?
3 Is there a written procedure for the cleaning and operation of the Compression machine?
4 Is there a written procedure for the cleaning and operation of a metal detector?
5 Is there a written procedure for issuance & retrieval of punches?
6 Have any punches received in the last 6 months?
7 Have any modification in the last 6 months in the compression machine?
8 Is the equipment log updated?
9 Are all the IPQC equipment calibrated and their log updated?
10 Is there a written procedure for handling of IPQC instruments?
  • Coating (Self Inspection Checklist)
1 Is the area & equipment neat, clean, and rust-free?
2 Is the equipment suitably designed for its purpose?
3 Is there a written procedure for the cleaning and operation of the coating machine?
4 Is the equipment qualified?
5 Have any modification in the last 6 months in the coating machine?
6 Is the equipment log updated?

  • Capsule filling (Self Inspection Checklist)
1 Is the area & equipment neat, clean, and rust-free?
2 Is the equipment suitably designed for its purpose?
3 Is there a written procedure for cleaning and operation of capsule filling & polishing machine?
4 Is the equipment qualified?
5 Have any modification in the last 6 months in the capsule filling & polishing machine?
6 Is the equipment log updated?

  • Packing (Self Inspection Checklist)
1 Is the area & equipment neat, clean, and rust-free?
2 Is the equipment suitably designed for its purpose?
3 Is there a written procedure for the cleaning and operation of the packing machine?
4 Are the entire equipment qualified?
5 Have any modification in the last 6 months in the packing machine?
6 Is the entire equipment log updated?
7 Is there a written procedure for the cleaning and operation of the leak test apparatus?
8 Is the leak test log book updated?

F.  Equipment Calibration – Self Inspection Checklist
1 Is there any written procedure for handling of calibration of measuring devices?
2 Is there an approved annual program for the Calibration of all production equipment?
3 Are the equipment items identified with a distinguishing code number?
4 Is all critical instrumentation on the equipment items identified with a valid calibration tag?
5 Are the Calibrations reports checked by appropriate personnel?
6 Are the reports completely and accurately filled out?

G. Other observation :

H. Data integrity observation :

Sr. No

 Observation Document no Page no

Remarks

3.0  Inspection checklist – Engineering / Maintenance.  

Sr. No.

 Requirements

Remarks

A. SOP
1 Are 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 SOP’s available at the respective places?  

B.  Personnel
1 Is there any written procedure available for training?  
2 Are training records of the employees working in the department up-to-date?  
3 Have the employees undergone training in the following areas?

  • cGMP
  • SOP’s
  • Engineering techniques
  • EU_GMP
  
4 Are several employees knowledgeable about their job functions?  
5 Are all employees following the garments SOP, including, where necessary, masks, gloves, and beard covers?  

C. Calibration Records
1 Are there written procedures available, which describe the calibration process?
2 Is there an approved annual calibration schedule?
3 Is there a tracking procedure in place to ensure that every instrument included in the program actually undergoes calibration on time?
4 Is the master list of instruments and calibration procedures available in the area? Are they maintained and updated?
5 Are traceable calibration standards employed?
6 Are there certificates of calibration available for the standards?
7 Is there written evidence that the calibration standard used was within calibration?
8 Were the instruments calibrated according to the frequency indicated in the relevant SOP?
9 Are the calibration reports checked by appropriate personnel?
10 Are the forms completely and accurately filled in?
11 Were all the calibrations within the defined limits of accuracy?
12 What procedure is followed if the results of the calibrations do not comply with the limits?
13 Is there any written procedure for the approval of the external calibration contractor?

D. Preventive Maintenance Records – Self Inspection Checklist
1 Is there an approved annual preventive maintenance program?
2 Are there written procedures for preventive maintenance for all utility equipment?
3 Are there written records of performance?
4 Examine the historical record of equipment?
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 equipment is included?
7 Are the maintenance manuals, drawings, wiring diagrams, and parts list of equipment under a preventive maintenance program?
8 Are all documents properly signed and dated?

E. Breakdown Maintenance Records
1 Are there written procedures for breakdown maintenance?
2 Is there a record of breakdown maintenance for each piece of the production equipment?

F. Drawings – Self Inspection Checklist
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?
5 Are any changes or modifications in drawings or facilities?

G. Alarms Procedures
1 Is there a well defined alarming system available? Specify the use.
2 Is there an SOP for responding to alarms for critical systems?
H.  Air Handling Unit – Self Inspection Checklist
1 Is there any written procedure for handling AHU?
2 Is the entire AHU qualified?
3 Is there any re-qualification schedule?
4 Is there an SOP for performing HEPA filter integrity tests?
5 Is there a filter replacement record update?
6 Examine records of the most recent tests performed.
7 Is the entire logbook of AHU updated?
8 Is the History card available & updated?
9 Is any modification in the last 6 month?
10 Is any AHU procured & installed in the facility in the last 6 months?

I.  Utility  (Self Inspection Checklist)
1 Is there any written procedure for the operation of the DG system?
2 Is there any modification in the DG system in the last 6 months?
3 Are the entire logbooks of utility updated?
4 Is the History card available & updated?

4.0  Inspection Checklist – Quality Control Laboratory (Analytical).  

Sr. No. Requirements Remarks
A. SOPs
1 Are the complete index and a complete set of applicable SOPs available in the department?
2 Are the index & annexure current?
B. Personnel
1 Are training records of the employees working in the department up-to-date?
2 Is Job Description of the employees working in the department up-to-date?
3 Have the employees undergone training in the following areas?
4 Are several employees knowledgeable about their job functions?
5 Is an up-to-date organizational chart of the Quality Control Department available?
6 Are all employees following the garments SOP, including whee necessary masks & gloves?

C.  Facilities  (Self Inspection Checklist)
1 Is the 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 the laboratory instruments/equipment qualified?
5 Are all reagents and solutions

  • Clearly, labeled with their proper name?
  • Labeled with the date of receipt and/or expiration date?
6 Are prepared solutions labeled with the

  • Name of the person who prepared them?
  • Date of preparation?
  • Expiration date?
7 Is there any written procedure available for status labeling?
8 Is the area qualified? Have any modification in the facility in the last 6 months?
9 Is there any written procedure available for recording temperature & % relative humidity?
10 Are the entire area log books updated?

D.  Instrumentation and Calibration (Self Inspection Checklist)
1 Is there an approved preventive maintenance program for all equipment/instruments used in the laboratory?
2 Is there evidence that it is followed?
3 Is the program based on the manufacturer’s recommendations?
4 If not, is there a documented rationale for the alteration of the schedule?
5 Is there documented evidence that the person who performs preventive maintenance is qualified to do so?
6 Are there written procedures for operating the instruments?
7 Are there written procedures for calibrating the instruments?
8 Is there a valid calibration status on each instrument?
9 Examine the calibration records for the instruments.

  • Are they up-to-date?
  • Are the results within limits?
10 Is there an SOP for corrective action if an instrument is found to be out of calibration?
11 Where standards are used to calibrate an instrument, is there a written procedure for their preparation?
12 Where ever applicable are the instruments are calibrated to the traceable standards?
13 Is there a schedule for validating the computer software program?
14 Is the schedule followed correctly?
15 Does the schedule include all the relevant software used in Q.C?

E. Sample Receipt, Storage, and Documentation (Self Inspection Checklist)
1 Is a specific person responsible for the receipt of samples for testing?
2 Is there a written SOP describing sample receipt and recording (logging in)?
3 Where are samples stored before and after testing?
4 Are samples retained after completion of testing and reporting? If not, What happens to samples after testing and reporting are complete?
5 Is there a time limit on how long a sample may remain in the laboratory prior to testing?
6 Are the reserve samples kept as per procedure?
7 Is the approved vendor list for all raw materials and packing materials available?
8 Is there any data backup policy available?
9 Is there any written procedure for the Audit trail?
10 What is the frequency of the audit trail?
11 Is there any written procedure for Chromeleon?
12 Is there any written procedure for the management of software & creation of user ID?

F.  Test Procedures (Self Inspection Checklist)
1 Are there approved test procedures available for all tests performed in the laboratory?
2 Is there a written procedure for ensuring that all pharmacopoeial procedures are updated when a supplemental monograph is issued?
3 Examine the work currently being performed on the HPLCs.
4 Is it up-to-date?
5 Is it being accurately followed?
6 Has the test method been validated for precision and reliability?
7 Has the analyst recorded all the relevant details of the product being tested, including the attachment of printouts or record of weighing?
8 Is there documented evidence that system suitability was determined prior to the use of the chromatography in the analysis?
9 Is there a reference to the test method used in the analyst’s Test Data Sheet (TDS)?
10 Do retention samples form part of laboratory records.
11 Is a written cleaning procedure available for all instruments and glassware?
12 Are laboratory records having the name of Product and Batch number?
13 Are laboratory records indicating the date of receipt of the sample and expiry date?

G. Recording Results (Self Inspection Checklist)
1 Examine an analyst’s Test Data Sheet.
2 Is it neatly filled in and legible?
3 Are any cross-outs initialed and dated?
4 Is there a record of the instrument used for testing together with any raw data?
5 Are all calculations recorded?
6 Are all charts, graphs, and printouts labeled with the

  • Product name and batch number?
  • Date of the test?
7 Are numbers rounded in accordance with an approved SOP?
8 Do the dates on graphs/charts match with the dates of analysis?
9 Is there a statement in the TDS as to whether or not the sample passes the test?
10 Is the analyst’s signature recorded in the TDS?
11 Are references to Instruments/Equipment’s and volumetric solutions used given in the TDS?

H. Reference Standards / Working Standards (Self Inspection Checklist)
1 Examine a reference standard.
2 Is it stored appropriately?
3 Is the document available for receipts of the same?
4 Is the standard tested internally to confirm its quality?
5 Is there a written SOP for the preparation of working standards?
6 How often are working standards prepared?
7 What expiration date is given to working standards?
8 Has the expiration date been validated?
9 Are working standards certified against compendia standards?
10 Is there a record of the preparation of volumetric solutions?
11 Are volumetric solutions freshly prepared?
12 If stored, what expiration date is given?
13 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 Do the responsibilities are clearly mentioned in the SOP for the handling of the OOS?
3 Is the logbook of OOS updated?
4 Check filled OOS with respect to current SOP.

J. OOT
1 Is there an SOP for OOT handling?
2 Do the responsibilities are clearly mentioned in the SOP for the handling of the OOT?
3 Is the logbook of OOT updated?
4 Check filled OOT with respect to current SOP.
K.  Evaluation of Results
1 Is there an SOP for a 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 TDS routinely reviewed by a supervisor?
4 Do reviewers sign the TDS to indicate that it has been reviewed?

L. Methods Validation (Self Inspection Checklist)
1 Have all in-house methods been validated?
2 Is there a written SOP relating to the validation of analytical methods?
3 Check method validation for any product which is done in between two self-inspections with respect to SOP.

M. Stability study (Self Inspection Checklist)
1 Is a stability study schedule available?
2 Are protocols for all stability study samples available?
3 Does the procedure for keeping stability samples available?
4 Are stability samples kept as per the storage requirement?
5 Are stability study test selection procedures available?
6 Is the stability summary available?

N. Other Observation:

5.0  Inspection Checklist – Quality Assurance (QA).  

Sr. No.

 Requirements

Remarks

A. SOP
1 Are a complete index and a complete set of applicable SOPs available in the department?  
2 Are the index, sops, and annexure current?  

B.  Personnel
1 Are training records of the employees working in the department up-to-date?  
2 Are Job Description of the employees working in the department up-to-date?  
3 Have the employees undergone training in the following areas?

  • GMP
  • SOP’s
  • Quality Assurance Procedures
  • EU_GMP
  
4 Question several employees about the operations they are performing.  Are they knowledgeable about their job functions?  
5 Is an up-to-date organizational chart of the Quality Assurance Department available?  
6 Are all employees following the garments SOP, including where necessary masks & gloves  

C. Batch Record Review (Self Inspection Checklist)
1 Is there an SOP for batch record review prior to release?
2 Is there a comprehensive checklist for batch record review prior to release?
3 Production records are evaluated and signed by an authorized person?
4 Examine recently released batch records.
5 Are the records complete with respect to the following?

  • The master formula is signed and dated as a true copy.
  • Any changes to the master formula are QA authorized prior to manufacturing
  • All relevant signatures are present.
  • Relevant data are present.
  • All relevant data are accurate.
  • Yield calculation at each stage of production.
  • All calculations are verified by a second individual.
  • Holding period of intermediate products.
  • All the reconciliation at each stage done correctly.

D. Change Control Records (Self Inspection Checklist)
1 Is there an SOP for batch Change control?
2 Are all changes that may impact product quality authorized by Quality Assurance prior to implementation?
3 Examine records for change control. Total No. Of change control:
4 Review some change control and record the observation
5 Is the change control log updated?
6 What is the closure out period of change control? If it is not closed within the period then what is the next action?
7 Were any required tests performed and the results evaluated prior to closing the forms?
8 Have all relevant documentation been updated?

Verify that validation protocols have been revised where appropriate.

E. Self-Inspection Checklist
1 Is the current version of SOP available?
2 Is there an updated list of self-inspection team?
3 Is the training imparted to the self-inspection team on self-inspection SOP & inspection skills?
4 Is self-inspection performed according to the frequency stated in the SOP? What is the frequency of self-inspection?
5 Are written reports available for all inspections performed during the year?
6 Is there written evidence of corrective action implemented as a result of the inspections?

F. Complaints (Self Inspection Checklist)
1 Is there a current version of SOP for dealing with complaints?
2 Examine the complaints for the last 6 months.
3 Do the files contain all the relevant data?
4 Have the files been signed and dated 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?
7 Is the market complaint log updated?

G. Non-conforming Batches (Self Inspection Checklist)
1 Examine the list of non-conforming batches for the last 6 months.
2 List the reason (s) for the rejection.
3 Specify at which stage of production the batches were rejected.
4 Is there a written investigation, including a conclusion as to the cause of the failure and, if appropriate, follow-up action for each of the batches?
5 Are there any products that have more than one rejected batch and, if so, has corrective action been recommended and implemented?
6 Is there a current version of SOP available?

H. Recalls                                                         SOP for Product Recall                             
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?
6 Is the mock recall logbook updated?
7 What is the frequency of Mock recall?
8 Review the record of the last Mock recall?

I. Qualification & Validation (Self Inspection Checklist)
a.    Process Validation
1 Is there a written procedure for carrying out validation of drug products?
2 Is the Master Validation Plan available?
3 Is the PV planner available?
4 Are the appropriate validations are done?
5 Is it followed?
6 Check the validation file of any one of the products being manufactured.
7 Review & check the compliance of process validation performed in the last 6 months.

b.    Cleaning Validation (Self Inspection Checklist)
1 Is there a written procedure available?  
2 Is the facility multipurpose or dedicated?  
3 Is there a cleaning validation matrix available?  
4 Is there an SOP for Rinse & Swab sampling available?  
5 Check the equipment hold time study record of any one of the equipment.  
6 Is the new API introduced in the last 6 months?  

c.    Equipment qualification
1 Is there a written procedure available?  
2 Check the qualification/re-qualification record of any one of the equipment.  
3 Is an initial qualification document available?  
4 Are the requalification criteria covered in the validation master plan?  
5 Is a re-qualification planner available?  
6 Is any equipment introduced in the facility?  

d.    SCADA System Validation  (Self Inspection Checklist)
1 Is there a written procedure available for handling of SCADA System?  
2 Are the requalification criteria covered in the validation master plan?  
3 Is a re-qualification planner available?  
4 Is any modification SCADA system in the last 6 months?  
e.    Computer System Validation
1 Is there a written procedure available?  
2 Is a re-qualification planner available?  
3 Are the requalification criteria covered in the validation master plan?  
4 Check the qualification/re-qualification record of anyone.  
f.     ECOM Validation
1 Is there a written procedure available for controlling & authorization?  
2 Is a re-qualification planner available?  
3 Is any modification ECOM system in the last 6 months?  
g.    Hold Time study of product
1 Is there a written procedure available?  
2 Check the hold time study record of the product performed in the last 6 months.  
h.    Cross-contamination study 
1 Is there a written procedure available?  
2 Is a re-qualification planner available?  
3 Is cross-contamination study covered in VMP?  
4 Is any contamination study performed in the last 6 months?  

J. Deviation Control and CAPA
1 Examine records for deviation control and CAPA
2 Is there a written procedure available for handling of deviation & CAPA?
3 Is Deviation & CAPA logbook is updated?
4 Are the deviations filled as per SOP and closed within the time frame?
5 If the deviation & CAPA is not closed within the specified period, then what is the next action?
K. Vendor Qualification                                     (SOP for Vendor Management)
1 Is there a written procedure available for qualification of the vendor?  
2 Is the approved vendor list available and updated?  
3 Are Vendor questionaries and TSE & BSE of vendor available? Check any one of the vendor documents.  
4 Is vendor qualification is covered in Validation Master Plan & is re-qualification criteria covered in the validation master plan?  
5 Is a Vendor re-qualification planner available?  
L. Training  (Self Inspection Checklist)
1 Is there a written procedure available?  
2 The basic training on the theory and practice of the quality management system and Good Manufacturing Practice?  
3 Is any specific training provided to the personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious, or sensitizing materials are handled?  
4 Is the annual training schedule available?  
M.  Annual Product Quality Review
1 Is there a written procedure available?  
2 Is any schedule available?  
3 Check the record of anyone product.  

N. Quality Risk Management                                                                      (SOP)
1 Is there a written procedure available?  
2 Is the Risk Assessment logbook is updated?  
3 Are the risk assessment done as per SOP and closed within the time frame?  
4 How many risks were done in the last 6 months? Review of any one of the risk assessment.  
O. Artwork
1 Is there a written procedure available?  
2 Check the compliance of the system.  
P. Release of Finished Product
1 Is there a written procedure available?  
2 Is the person & responsibility defined for the release of the batch?  
3 Is there any list of authorized persons available for the release of the batch?  
Q. Control sample
1 Is there a written procedure available?  
2 Is the control sample record updated?  
3 Is there a written procedure available for recording the environmental conditions?  
4 Is physical verification of the control sample done as per periodic review?  
5 Is destruction record updated and sample destroyed as per SOP?  

R. Document & Data Control  (Self Inspection Checklist)
1 Is there a written procedure available?  
2 Is the documents issuance Logbook updated?  
3 Are old documents preserved as per defined procedure?  
4 Is any written procedure available for preparation, issuance & retrieval of SOP?  
5 Check the compliance of SOP.  
S. Other observation :
     
T. Data integrity observation :
         

6.0  Inspection Checklist – Water System.  

Sr. No.

 Requirements

Remarks

A. SOPs
1 Are 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 SOP’s available at the respective places?

B. Personnel

1

 Is there any written procedure available for training?

2

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

  • cGMP
  • SOP’s
  • Engineering techniques
  • EU_GMP

4

 Are several employees knowledgeable about their job functions?

5

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

C. Walk-Through of System (Self Inspection Checklist)

1

 Perform a walk-through inspection of the entire system.

2

 Is the general environment clean and tidy for

  • Potable water storage?
  • The purified water production system?
  • The purified water storage system?

3

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

4

 Are the 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?

D. System Drawings (Self Inspection Checklist)

1

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

  • The system operator?
  • Maintenance personnel?

2

 Compare the drawings with those in the most recent validation file. Are they the same?

3

 Have any changes been authorized by Quality Assurance?

4

 Has a change control form been completed?

5

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

6

 Did the results meet the specifications?

E. System Operating Records  (Self Inspection Checklist)

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?

F. System Maintenance Records
1. Examine records of the performance of preventive maintenance. Do they include the following?

  • Cleaning and sanitation of the main water holding tank
  • Sanitation and  Cleaning of the purified water production system
  • Cleaning and sanitation of the purified water storage system

G. System Monitoring Records

1.

 Is 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?

H. System Validation File (Self Inspection Checklist)
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. Has any nonconformity with the validation protocol been indicated in the report, explained, and suitably authorized?
I. Other observation :

7.0  Inspection Checklist – Microbiology.

Sr. No.

 Requirements

Remarks
A. SOPs

1

 Are a complete index and a complete set of applicable Specifications and STP’s, available in the department?

2

 Are the Index, SOP & annexure current?
B. Personnel

1

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

2

 Are Job Description of the employees working in the department up-to-date?

3

 Have the employees undergone training in the following areas?

  • cGLP
  • SOP’s
  • Analytical Techniques
  • EU_GMP

4

 Are several employees knowledgeable about their job functions?

5

 Is an up-to-date organizational chart of the Quality Control Department available?

6

 Are all employees following the garmenting SOP, including whee necessary masks & gloves?

C.  Facilities  (Self Inspection Checklist)

1

 Is the 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 the laboratory instruments/equipment are qualified

5

 Are all media and solutions

  • Clearly, labeled with their proper name?
  • Labeled with the date of receipt and/or expiration date?

6

 Is the cleanroom maintained in a good state of repair?

7

 Is there any SOP for the cleaning and fumigation of the cleanroom?

8

 Is there any written procedure for the preparation of disinfectants?

9

  Are disinfectants labeled with expiration dates?

10

 Are cleaning records available and correctly filled out?

D. Instrumentation & Calibration  (Self Inspection Checklist)

1

 Is there an approved preventive maintenance program for all equipment used in the laboratory?

2

 Is there evidence that it is followed?

3

 Is there an approved calibration schedule for all instrumentation in the laboratory?

4

 Is there evidence that it is followed?

5

 Are there written procedures for operating the equipment?

6

 Is there a valid calibration card on each instrument?

7

 Are temperature recorders attached to all incubators and refrigerators?

8

 Are there any approved SOP that requires the routine checking and signing of temperature records?

9

 Are there any SOP /defining cleaning and sanitization procedures for the incubators and refrigerators?

10

 Is there documented evidence that it is being followed?

11

 Examine the most recent validation file for the autoclave.

12

 Was the validation performed as per schedule?

13

 Do the results meet the relevant acceptance criteria?

E. Sample Receipt, Storage, and Documentation (Self Inspection Checklist)

1

 Is a specific person responsible for the receipt of samples for testing?

2

 Is there a written SOP describing sample receipt and recording (logging in)?

3

 Where are samples stored before and after testing?

4

 Are samples retained after completion of testing?

5

 What happens to samples after testing and reporting are complete?

6

 Examine the contents of a refrigerator and an incubator.

7

 Is the equipment clean?

8

 Are all test samples recorded in the laboratory logbook?

9

 Are all items clearly labeled?

F. Test Procedures (Self Inspection Checklist)

1

 Are there approved test procedures available for all tests performed in the laboratory?

2

 Is there a written procedure for ensuring that all pharmacopoeial procedures are updated when a supplemental monograph is issued?

3

 Examine the work currently being performed.

4

 Is the test procedure at hand?

5

 Is it up-to-date?

6

 Is it being accurately followed?

7

 Has the test method been validated for precision and reliability?

8

 Are records available for the preparation of media used for performing the test?

9

 Is the media labeled with an expiration date?

10

 Is labeling done in accordance with an approved SOP?

11

 Is the analysis recorded in the approved formats/protocols prior to beginning work?

12

 Is there a written Microbial monitoring program for non-sterile products?

G. Recording Results

1

 Is it neatly filled in and legible?

2

 Are any cross-outs initiated and dated?

3

 Are all calculations recorded?
H. Stock Cultures

1

 Is there an SOP for the receipt and handling of Microbial Type Culture Collection (MTCC)?

2

 Are cultures received with a certificate of analysis?

3

 How often are MTCC cultures transferred?
I. Evaluation of Results

1

 Are DATA routinely reviewed by a supervisor?

2

 Do reviewers sign the DATA to indicate that it has been reviewed?
J. 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 cleanroom?

4

 Do results conform with 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

 Check the trend charts of environment control (settle plate exposure and air sampling) in production areas.
K. Other Observation

8.0  Inspection Checklist – HR / Administration :

Sr. No.

 Requirements

Remarks
A. SOP

1.

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

2.

 Are the index, sops & annexure current?  
B.  Personnel

1.

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

2.

 Are Job Description of the employees working in the department up-to-date?  

3.

 Have the employees undergone training in the following areas?

  • GMP
  • SOP’s
  • HR
  • EU_GMP
  

4.
  • Question several employees about the operations they are performing.
  • Are they knowledgeable about their job functions?

5

 Is an up-to-date organizational chart available?

6

 Are all employees following the garmenting SOP, including whee necessary masks & gloves?

C. Pest Control  (Self Inspection Checklist)

1.

 Is there 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.
  • All relevant data are present.
  • Relevant data are accurate.
  • Are all the records properly verified by the pest control Agency?
  • Is the pest control agreement available?
D. Other Records   (Self Inspection Checklist)

1.

 Are there written procedures for the Medical Checkup of Employees?

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 Linen and lockers?

6.

 Check the Linen records

7.

 Are the records complete with respect to the following?

  • All relevant signatures are present.
  • Relevant data are present.
  • Relevant data are accurate.

8.

 Are there procedures for safety and fire fighting available?

9.
  • Is enough awareness created by the company for maintaining safety and fire fighting?
  • Is training imparted on fire fighting technics? Are the records maintained?
E. Statutory Requirements

1.

 Are documents pertaining to the following maintained and updated?

  • Factory Inspectorate
  • Safety
F. Other observation :

9.0  Inspection Checklist – Production (Oral Liquid) :

Sr. No.

 Requirements

Remarks
A. SOP

1

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

2

 Is the current version of the SOP index available?  

3

 Are the SOP’s available at the respective places?  
B.  Personnel

1

 Is there any written procedure available for training?  

2

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

3

 Have the employees undergone training & evaluation in the following areas?

  • cGMP
  • SOP’s
  • Production techniques
  • EU_GMP
  

4

 Are several employees knowledgeable about their job functions?   

5

 Is there any written procedure available for the gowning system?  

6

 Are all employees following the garmenting SOP, including, where necessary, masks and gloves?  
C.  Facilities Review  – Self Inspection

1

 Is the department maintained in a good state of repair?

2

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

3

 Are all work areas clearly labeled with the name?

4

 Is there any written procedure available for status labeling?

5

 Is the area qualified? Have any modification in the facility in the last 6 months?

6

 Is there any written procedure available for recording temperature & % relative humidity?

7

 Are the entire area log books updated?

D.  Prevention of Cross-Contamination Review  – Self Inspection

1

 Are the doors closed at all times? Do they know the purpose of the airlock?

2

 Is a personnel clothing clean, unstained, and dust-free, including foot wares?

3

 Is there any written procedure available for monitoring Deferential pressure?

4

 Is pressure differential is maintained in working areas at all times during work?

5

 Is the logbook of the pressure differential updated?

6

 Is the compressed air & nitrogen air in the area qualified? Have a re-qualification planner?

7

 Is there an SOP for the cleaning and replacement of these filters?

E.  Area & Equipment Review  – Self Inspection
  • Raw material Day Stores

1

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

2

 Is all the material stored on pallets:

3

 Is inward & outward log update?

4

 Is balance calibrated and log of balance updated?
  • Manufacturing

1

 Is the area & equipment neat, clean, and rust-free?

2

 Is the equipment suitably designed for its purpose?

3

 Are 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?

4

 Is there a machine history card available?

5

 Is there a written procedure for the cleaning and operation of the manufacturing vessel?

6

 Is there a written procedure for the cleaning and operation of the storage vessel?

7

 Is there a written procedure for the cleaning and operation of the stirrer?

8

 Is the entire equipment log updated?

9

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

10

 Is there a written procedure for cleaning and operation of pH meter?

11

 Is the equipment log updated?
  • Filling  &Sealing

1

 Is the area & equipment neat, clean, and rust-free?

2

 Is the equipment suitably designed for its purpose?

3

 Are 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?

4

 Is there a written procedure for cleaning and operation of the Filling & sealing machine?

5

 Is the Filling & sealing machine qualified?

6

 Is the equipment log updated?

7

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

8

 Is a measuring cylinder calibrated?

9

 Is there a written procedure for the cleaning of Plastic / HDPE containers after use?

F.  Equipment Calibration Review  – Self Inspection

1

 Is there any written procedure for handling of calibration of measuring devices?

2

 Is there an approved annual program for the Calibration of all production equipment?

3

 Are the equipment items identified with a distinguishing code number?

4

 Is all critical instrumentation on the equipment items identified with a valid calibration tag?

5

 Are the Calibrations reports checked by appropriate personnel?

6

 Are the reports completely and accurately filled out?

10.0  Inspection Checklist – Information Technology (IT) :

Sr. No.

 Requirements

Remarks
A. SOP

1

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

2

 Is the current version of the SOP index available?  

3

 Are the SOP’s available at the respective places?  
B.  Personnel

1

 Is there any written procedure available for training?  

2

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

3

 Have the employees undergone training & evaluation in the following areas?

  • cGMP
  • SOP’s
  • Information Technology
  • EU_GMP
  

4

 Are several employees knowledgeable about their job functions?  

C.  Facilities Review  – Self Inspection

1

 Is the department maintained in a good state of repair?

2

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

3

 Are all work areas clearly labeled with the name?

4

 Is there any written procedure available for status labeling?

5

 Is any modification in the server in the last 6 months?

D.  Documentation Review  – Self Inspection

1

 Is there any written procedure available for handling of server?

2

 Is there any written procedure available for data backup policy?

3

 Is there any written procedure available for handling computer system validation?

4

 Is there a re-qualification planner available for computer system validation?

5

 Is there any written procedure for handling of Computer System Failure?

6

 Is there any written procedure for handling chromatographic system access control, user account management, and data management?

7

 Is there any list available for authorized ECOM users?

8

 Is there any list of users of the chromatographic systems?

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Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com