1. Whether adequate facilities, trained persons and approved procedures are available?
2. Is there an organized and documented system for specification, sampling, testing and release of materials and products?
3. Is there a system for approval or rejection of materials and products?
4. Whether quality control is involved in all the decisions concerning the quality of the product?
5. Is there a method for sampling of starting materials, bulk and finished products with supporting SOP?
6. Whether the testing methods are validated?
7. Whether records are maintained?
8. Are there records to show that sampling, inspection and testing procedures are carried out as per the procedures stipulated?
9. Are there any OOS result found and what are the actions taken?
10. Whether each and every MOA is reviewed and evaluated thoroughly?
12. Whether control samples are kept in their final pack?
13. Whether the reference standards are evaluated, maintained and stored properly with LOG?
14. Are the laboratory reagents and other chemical supplies identified, tested and expiration dated?
15. Whether all the tests of either starting materials or finished products are carried out as per the specifications?
16. Is there a list available of specification numbers for starting materials (both RM & PM) and finished products?
17. Whether all the C.O.A’s bear specific specification reference number?
18. Are control samples of finished products retained for a period of at least one year after the date of expiry?
19. Whether materials are purchased only from the approved vendor? Check the MRV.
20. Whether changes incorporated in the specifications are reflected in the future purchase orders or is there a system to communicate accordingly?
21. Whether the approved vendor list is reviewed as per the SOP?
22. Does the SOP exist to describe the labeling, packing and handling of the raw material control sample?
23. Does the SOP exist to reanalysis the complaints and Return or recalled materials?
24. Is there a method to confirm the identity of the contents of each container of starting material?
25. Is there any control on the purchase, handling of primary and printed packaging materials?
26. Whether all the reagents, chemicals and culture media are recorded on the receipt?
27. Whether the W.S. / reference standards are kept under the responsibility of a designated person in a secure area?
28. Is there an SOP for sampling and which specifies the person(s) authorized to take samples and which also include:
30. Whether the TLC qualifications are documented?
31. Whether separate registers are maintained by analytical chemists to record the complete testing with product or material released stamp and are counter checked by the responsible person?
32. Whether references to working standard and volumetric solutions are made in the records / LOG?
33. Whether control samples entries are made properly according to the SOP?
34. Is temperature record available for control sample room?
35. Are destruction records of control sample updated?
36. Whether the lab is well equipped to carry out all the required tests.
37. Whether the Chemical & Media consumption records are maintained?
38. Whether the growth promotion tests are carried out?
39. Whether the culture maintenance records are updated?
40. Whether temperature charts/records available for BOD incubators?
41. Whether complete validation is carried out for BET kit?
42. Whether the calibration of the heating block for BET test is done?
43. Whether calibration of a micropipette is done?
44. Whether sterility test failure investigations are carried out?
45. Is there an SOP for actions taken in case of water analysis failures?
46. Is there an SOP for actions taken in case of endotoxin failure?
47. Is there an SOP for actions taken in case of environmental monitoring failure?
48. Whether validation record for autoclave available?
49. Whether validation record for D.H.S. available?
50. Whether calibration records for all the measuring devices (gauges, manometer) available?
51. Whether validation LAF carried out as per the schedule?
52. Whether filter integrity tests for filters of LAF carried out?
53. Whether the disposal of media is carried out as per the SOP?
54. Whether the calibration of incubators carried out?
55. Whether validation for rotation of disinfectants is done?
56. Whether pre-filters of LAF cleaned as per the preventive maintenance schedule?
57. Whether control standard endotoxin No., LAL reagent water No., Lysate No. of bacterial endotoxin test kit are reflected in the respective analysis records?
58. Are water analysis and environmental records available in microbiology section?
59. Are BET and sterility testing records available?
60. Whether autoclave operation records available?
62. Is there a sampling plan for water from different sources and at different user points?
63. Is there a sampling plan for the air of specific area? (Both viable and non-viable) 64. Whether micro-organisms are identified in case results are exceeding the limits of viable counts?
65. Whether the planner for calibration of balances is made and recorded? (Department wise)
66. Whether the planner for calibration of instruments is made and followed accordingly?
67. Whether the tolerance of balances is within the standard acceptable limit?
68. Whether a planner is made for calibration of all measuring devices? (Pressure gauges, manometer, magnahlic gauges).
69. Whether calibrations are also carried out in case of breakdown of instruments? Is there any supporting SOP for the same?
70. Are records of calibration checks and inspections maintained in a readily retrievable manner?
71. Is there an approved written procedure for checking and calibration of each piece of measurement equipment?
72. Is there an adequate stability/shelf life determination programme?
73. Whether all the products with all the respective primary packaging materials are kept for stability studies and system is followed?
74. Whether protocols are there for all the products and packs with all the details like product code, sp.no. conditions of temp. and RH?
75. Whether studies are conducted as per the schedule?
76. Whether records are maintained for the products kept for the stability studies and results are satisfactory?
77. Are there any investigations and action plans in case of stability failure with respect to different storage conditions i.e. accelerated, intermediate and long-term/real time?
78. Whether qualifications (DQ, IQ, OQ & PQ) are carried out for all the ovens?
79. Is there a SOP for the arrangement of samples in the oven?
80. Whether temp. and RH of ovens/ Humidity chambers are maintained and recorded properly?
82. Is there a system by which the information is received for changes, which require stability studies and are recorded and followed?
83. Whether the results are properly supported with logbook scans, chromatograms etc.?
84. Whether the stability report evaluates, recommends and concludes the stability results?
85. Whether the batches and the products are considered for studies, which are prospectively validated?
2. Is there an organized and documented system for specification, sampling, testing and release of materials and products?
3. Is there a system for approval or rejection of materials and products?
4. Whether quality control is involved in all the decisions concerning the quality of the product?
5. Is there a method for sampling of starting materials, bulk and finished products with supporting SOP?
6. Whether the testing methods are validated?
7. Whether records are maintained?
8. Are there records to show that sampling, inspection and testing procedures are carried out as per the procedures stipulated?
9. Are there any OOS result found and what are the actions taken?
10. Whether each and every MOA is reviewed and evaluated thoroughly?
12. Whether control samples are kept in their final pack?
13. Whether the reference standards are evaluated, maintained and stored properly with LOG?
14. Are the laboratory reagents and other chemical supplies identified, tested and expiration dated?
15. Whether all the tests of either starting materials or finished products are carried out as per the specifications?
16. Is there a list available of specification numbers for starting materials (both RM & PM) and finished products?
17. Whether all the C.O.A’s bear specific specification reference number?
18. Are control samples of finished products retained for a period of at least one year after the date of expiry?
19. Whether materials are purchased only from the approved vendor? Check the MRV.
20. Whether changes incorporated in the specifications are reflected in the future purchase orders or is there a system to communicate accordingly?
21. Whether the approved vendor list is reviewed as per the SOP?
22. Does the SOP exist to describe the labeling, packing and handling of the raw material control sample?
23. Does the SOP exist to reanalysis the complaints and Return or recalled materials?
24. Is there a method to confirm the identity of the contents of each container of starting material?
25. Is there any control on the purchase, handling of primary and printed packaging materials?
26. Whether all the reagents, chemicals and culture media are recorded on the receipt?
27. Whether the W.S. / reference standards are kept under the responsibility of a designated person in a secure area?
28. Is there an SOP for sampling and which specifies the person(s) authorized to take samples and which also include:
- Method of sampling and sampling plan
- Equipment to be used
- Precautions (to avoid contamination, sterile, noxious material)
- Amount of sample
- Instruction for subdivision
- Sampling device cleaning & utilization log
30. Whether the TLC qualifications are documented?
31. Whether separate registers are maintained by analytical chemists to record the complete testing with product or material released stamp and are counter checked by the responsible person?
32. Whether references to working standard and volumetric solutions are made in the records / LOG?
33. Whether control samples entries are made properly according to the SOP?
34. Is temperature record available for control sample room?
35. Are destruction records of control sample updated?
36. Whether the lab is well equipped to carry out all the required tests.
37. Whether the Chemical & Media consumption records are maintained?
38. Whether the growth promotion tests are carried out?
39. Whether the culture maintenance records are updated?
40. Whether temperature charts/records available for BOD incubators?
41. Whether complete validation is carried out for BET kit?
42. Whether the calibration of the heating block for BET test is done?
43. Whether calibration of a micropipette is done?
44. Whether sterility test failure investigations are carried out?
45. Is there an SOP for actions taken in case of water analysis failures?
46. Is there an SOP for actions taken in case of endotoxin failure?
47. Is there an SOP for actions taken in case of environmental monitoring failure?
48. Whether validation record for autoclave available?
49. Whether validation record for D.H.S. available?
50. Whether calibration records for all the measuring devices (gauges, manometer) available?
51. Whether validation LAF carried out as per the schedule?
52. Whether filter integrity tests for filters of LAF carried out?
53. Whether the disposal of media is carried out as per the SOP?
54. Whether the calibration of incubators carried out?
55. Whether validation for rotation of disinfectants is done?
56. Whether pre-filters of LAF cleaned as per the preventive maintenance schedule?
57. Whether control standard endotoxin No., LAL reagent water No., Lysate No. of bacterial endotoxin test kit are reflected in the respective analysis records?
58. Are water analysis and environmental records available in microbiology section?
59. Are BET and sterility testing records available?
60. Whether autoclave operation records available?
62. Is there a sampling plan for water from different sources and at different user points?
63. Is there a sampling plan for the air of specific area? (Both viable and non-viable) 64. Whether micro-organisms are identified in case results are exceeding the limits of viable counts?
65. Whether the planner for calibration of balances is made and recorded? (Department wise)
66. Whether the planner for calibration of instruments is made and followed accordingly?
67. Whether the tolerance of balances is within the standard acceptable limit?
68. Whether a planner is made for calibration of all measuring devices? (Pressure gauges, manometer, magnahlic gauges).
69. Whether calibrations are also carried out in case of breakdown of instruments? Is there any supporting SOP for the same?
70. Are records of calibration checks and inspections maintained in a readily retrievable manner?
71. Is there an approved written procedure for checking and calibration of each piece of measurement equipment?
72. Is there an adequate stability/shelf life determination programme?
73. Whether all the products with all the respective primary packaging materials are kept for stability studies and system is followed?
74. Whether protocols are there for all the products and packs with all the details like product code, sp.no. conditions of temp. and RH?
75. Whether studies are conducted as per the schedule?
76. Whether records are maintained for the products kept for the stability studies and results are satisfactory?
77. Are there any investigations and action plans in case of stability failure with respect to different storage conditions i.e. accelerated, intermediate and long-term/real time?
78. Whether qualifications (DQ, IQ, OQ & PQ) are carried out for all the ovens?
79. Is there a SOP for the arrangement of samples in the oven?
80. Whether temp. and RH of ovens/ Humidity chambers are maintained and recorded properly?
82. Is there a system by which the information is received for changes, which require stability studies and are recorded and followed?
83. Whether the results are properly supported with logbook scans, chromatograms etc.?
84. Whether the stability report evaluates, recommends and concludes the stability results?
85. Whether the batches and the products are considered for studies, which are prospectively validated?
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