Audit Checklist: Here is the tentative Audit checklist [Internal Audit/Self Inspection Checklist] for Quality Control Department. You may follow the below list at the time of Audit [Internal Audit/Self Inspection] for Quality Control Department-
1. Approved Departmental Organogram.
2. Approved vendor List of Raw and Packaging Materials.
3. Acceptance Record of Raw Material and Packaging Material.
4. Approval or Rejection of Materials and Products.
5. Controlling method of
- Purchase
- Primary Packaging and
- Printed Packaging Materials
6. Data Verification based on Logbook and Chromatograms.
7. Document retrieval and achieving Procedure.
8. Collection of retained sample and retrieval system.
9. Certificate of analysis.
- Primary data
- Checking of calculations
- Preservation of primary data
10. Certification of Products for Release.
11. Chemical Reagents consumption records.
12. Calibration Record Keeping for the instruments.
13. Calibration schedule/calendar of instruments.
14. Disinfectant effectiveness testing based on different concentration.
15. Documentation
- Material receiving report
- Preservation of original data
- Final report
- Communication with related department e.g- Supply chain, Warehouse, Accounts
16. Health checks for all personnel
- Pre-employment
- Yearly
- Record
17. In-process analysis (Specification & method)
- Currently revised
- Revision procedure
- Validation
- Approval
18. Instruments SOPs of operation, maintenance & calibration
- Operation Logbook
- Calibration
- Servicing
- Documentation
19. Investigation of Test Failure.
20. Job Responsibilities of all personnel are available.
21. List of Reagents & Solvents.
22. Laboratory Reagents
- Identified
- Tested
- Expiration dated
23. Maintaining of Reference Number for
- Specification
- Starting materials (both RM & PM)
- Finished products
- Certificate of Analysis
24. Management of HPLC columns.
25. Method for Identification of each starting materials container.
26. Management of Working Standard/Reference Standard.
27. Management of analytical worksheets.
28. Method Validation of Testing Product.
29. Maintain and storage of HPLC Column and column suitability test.
30. Management of Control Sample.
31. Practice and Record keeping of OSS with action plan.
32. Personnel engaged in analytical activity.
- Personnel Hygiene
- Lab Coat
33. Prohibited in working area
- Smoking
- Chewing tobacco
- Eating/ Drinking
34. Preparation and record keeping of working standard and volumetric solutions.
35. Record Keeping of
- Sampling
- Inspection and
- Testing procedures
36. Reference Standard
- Evaluation
- Maintaining
- Record Keeping
- Logbook Entry
- Storage
37. Receiving Record of
- Reagents
- Chemicals
- Culture Media
38. Retesting procedure
39. Received Material
- Sampling Plan
- Sampled Quantity
40. Real Time & On-going Stability Study Calendar/Schedule.
41. Qualification [DQ, IQ, OQ & PQ] records of Oven.
42. Real Time & On-going Stability Study Sample Receiving Record.
43. Real Time & On-going Stability Study Failure Investigation.
44. Real Time & On-going Stability Study Report Evaluation, Recommendations and Conclusion.
45. Safety
- Fire extinguishers-adequacy
- First aid-adequacy
- Possibility of potential electrical hazards
46. SOP on cleaning
- Glass apparatus
- General cleaning of department
47. SOP on Material Coding System.
48. SOP on calibration of measurement equipment.
49. SOP on Handling of breakdown of stability chambers.
50. SOP for sampling of
- Starting Materials
- Bulk Materials and
- Finished Products
51. SOP for
- Label and labeling system
- Packing Materials handling
- Handling of the raw material
- Reanalysis
- Testing of Market Complaints Sample
- Testing of Recalled Products
- Return products
52. Stability study
- List of products under stability study
- Stability protocols & reports
- Temp. % RH monitoring records of the stability chambers
53. Shelf life extension programme based on Real Time Stability Study.
54. Stability Study Record of Primary packaging materials.
55. Standardization of volumetric solution & documentation.
56. SOP for Sampling and Management of Raw Materials, Packaging materials.
57. Sampling of Water System.
58. Specification & Methods
- Currently revised
- Revision procedure
- Validation
- Approval
59. Standard Lab requirement availability
- Adequate facilities
- Trained persons
- Analyst Validation
- Approved procedures
60. Standard documented system for
- Specification
- Sampling
- Testing and
- Release of materials and products
61. Testing
- Physical
- Chemical
- Microbiological/ Biological
62. Tolerance of Electronic balances.
63. Testing of Validation Batch/Scale Up batch Record.
64. Temperature and Relative Humidity Monitoring Record of Oven Humidity chambers.
65. TLC qualifications are document keeping.
66. Validated Excel Sheet for Calculation.
66. Working standards & reference standards.
- Maintenance
- Documentation
- Listing
1. Air Sampling plan of Specific Area .
2. Autoclave validation Record.
3. Autoclave operational Record.
4. Bacterial Endotoxin Test[BET], Sterility Test, Environmental Monitoring Test failure investigation report.
5. Calibration records of equipment’s.
6. Calibration & Recording keeping of Micropipette.
7. Calibration records of measuring devices.
8. Calibration record for heating block for BET.
9. Disposal of microorganism, used culture media, used plates etc.
10. Environmental monitoring records.
11. Growth promotion records of media.
12. Environmental Monitoring and Water Analysis Record.
13. Filter integrity tests record for filters of LAF.
14. Incubators calibration Record.
15. LAF Validation schedule.
16. Microbial culture management.
- Name of the organisms
- ATCC/NCTC numbers
- Sub-culturing of organisms
- Preservation of microbial culture
17. Master list of SOPs, specifications & methods are updated.
18. Operational Logbooks .
19. Preventive Maintenance schedule for LAF filter cleaning.
20. Record Keeping for Bacterial Endotoxin Test[BET] and Sterility Test.
21. Stock stains available.
22. Testing area.
- Adequacy of space
- Adequacy of equipment
- Cleanliness
23. SOP for
- Gowning and De-Gowning Procedure Though the Change Room of Microbiology Area
- Management of Water Sampling and Testing
- Microbial Disposal of Waste Media
- Operation of Colony Counter for Microbiology
- Cleaning and Sanitation of Microbiology Laboratory
- Operation and Maintenance of Single Door Autoclave
- Operation, Calibration and Maintenance of Laminar Air Flow Cabinet
- Operation and Maintenance of Bacterial Incubator
- Operation and Cleaning Procedure of Oven
- Preparation and Preservation of Microbiological Media
24. Temperature charts and records of BOD incubators
25. Validation of autoclave machine
26. Validation of LAF
27. Validation Record of BET kit
28. Water monitoring records
This is all about the Audit Checklist [Internal Audit/Self Inspection Checklist] for Quality Control Department [QC & Microbiology Lab] [but not limited to]