Self audit of Medical Store :105 points

Last Updated on November 27, 2024 by The Health Master

Self audit of the medical store is important

Self audit or self-inspection of the medical store is suggested for the assessment of the workings of the firm, whether the firm is working as per the Drugs and Cosmetics Act 1940 and Rules framed thereunder or not.

It should be conducted periodically by the Prop. / Partners / Directors and / or Competent person (Regd. Pharmacist / Experience Person of the firm.

The improvement or rectification should be done immediately as per the observations made during the self-audit of a medical store.

Here is the checklist for a self audit for a medical store:

Self-inspection / audit of medical store / Drug sale unit (Retail and/or Wholesale units)

Abbreviations:
RSDL: Retail Sale Drug License
WSDL: Whole Sale Drug License
CP: Competent Person
RP: Registered Pharmacist
EP: Experience Person
RMP: Registered Medical Practitioner
DCO: Drugs Control Officer
NSQ: Not of std. quality
CS: Civil Surgeon
TB: Tuberculosis

Checklist for Self audit or inspection of Drug sale unit Retail and / or Wholesale units Date …………………..Done by ………………

1. Distt. 

2. Name of the firm 

3. Address of the firm 

4. License No. of the firm 

5. License granted on Dated ………..

6. Validity of the license Dated…………

7. License Retention fee submitted (If due) Yes / No 
(Submit license retention fee within time limit.)

8. Proof of submission of the license retention fee was kept. Yes / No
(Proof of License retention fee must be kept in the record.)

9. Constitution of the firm: Proprietorship / Partnership / Pvt. Ltd. / Ltd firm

10. Any change in the constitution. Yes / No

11. Have you applied for a new license due to a change in the constitution in time (If the constitution changed)? Yes / No / NA
(Apply for change in constitution within 90 days.)

12. Name(s) of Prop. / Partners / Directors of the firm 

13. Name of the responsible person of the firm 

14. Have you changed the premises without obtaining a fresh license? Yes / No
(Obtain a fresh license before changing the premises.)

15. A file regarding correspondence with the Drug Department is maintained. Yes / No
(Keep a file of all correspondence with the drug department.) (e.g. letters, notices, circulars, etc.)

16. Whether the firm’s licenses have ever been suspended or partially canceled. Yes / No
(Obey Drugs and Cosmetics Rules.)

17. Whether a signboard with the name of the firm is displayed. Yes / No
(Display signboard with the name of the firm.)

18. Whether “Chemist and Druggist” is written on the sign board. Yes / No
(“Chemist and Druggist” must be written on the signboard)

19. Whether the drug license is displayed in a prominent place. Yes / No
(Display drug license at a prominent place.)

20. Name of Competent Person (RP / EP) of the firm

21. Regn. Number of RP 

22. Validity of Regn. of RP 
(Validity of Regn. Certificate of RP must be up to date.) 

23. Whether Regn. Certificate of RP displayed. Yes / No
(You should display Regn. Certificate of RP.)

24. Joining date of CP 

25. Whether any change in CP. Yes / No

26. Resignation date of CP (If resigned) 

27. Whether new CP appointed (If resigned)Yes / No

28. Whether information of change in CP has been given to the drug department within one month. Yes / No

29. If yes, the date of appointment of the new CP 

30. Name of new CP

31. Regn. Number of CP 

32. Validity of Regn. of CP 

33. Whether there is a gap between resigning and joining a new CP, if any, No, if yes ……days

34. If yes, the sale or purchase of drugs during the gap period. Yes / No
(No sale/purchase of drugs should be done in the absence of CP.)

35. Whether a dust free environment is maintained on the premises. Yes / No
(Keep your premises neat and clean.)

36. Whether the purchase record of drugs is maintained properly. Yes / No
(Maintain purchase record of every drug properly.)

37. Whether purchase records are maintained in chronological order (Maintain purchase records in chronological order) Yes / No

38. Whether drugs are purchased from licensed dealers. Yes / No
(Always purchase the drugs from licensed dealers only.)

39. Whether purchase invoices bear all the mandatory details. Yes / No
(Purchase invoice should have all mandatory drug details.)

40. Whether drugs are being sold under the personal supervision of RP. Yes / No
(Sale of drugs must be under the personal supervision of CP only.)

41. Whether drugs are being sold on prescription of RMP. Yes / No
(Sell the drugs on the prescription of a RMP.)

42. Whether substituting the prescription of RMP. Yes / No
(Do not substitute the prescription of RMP.)

43. Selling drugs at a price higher than MRP. Yes / No
(Do not sell the drugs at a price higher than MRP.)

44. Sale records of drugs are maintained. Yes / No
(Maintain sale record of the drugs.)

45. Sale records are maintained in a legible manner. Yes / No
(Maintain sale record of the drugs in a legible manner.)

46. The prescriber’s name and address are mentioned. Yes / No
(Mention name and address of prescriber.)

47. Name and address of patients mentioned. Yes / No
(Mention name and address of patient.)

48. Is the sale record having all other mandatory details? Yes / No
(sale record of drugs should have all mandatory details.)

49. Sale invoice signed by RP. Yes / No
(Sale invoices must be signed by CP)

50. Schedule-H1 register maintained. Yes / No
(Maintain Schedule-H1register)

51. Full-time electricity supply. Yes / No
(Full-time electricity supply must be ensured to maintain the desired temperature of the drugs)

52. If not, a generator is maintained. Yes / No
(Full-time electricity supply must be ensured to maintain the desired temperature of the drugs.)

53. Direct sunlight on the drugs. Yes / No
(Drugs should not be exposed to direct sunlight.)

54. Refrigerator maintained. Yes / No

55. Whether there is an adequate gap between the wall and the refrigerator. Yes / No
(maintain an adequate gap between the wall and the refrigerator.)

56. The refrigerator is in working condition. Yes / No
(Refrigerator must be in working condition.)

57. The temperature of the refrigerator is maintained. Yes / No
(Temperature of the refrigerator must be maintained.)

58. Stocking the drugs in the refrigerator, which does not require storage in the refrigerator. Yes / No
(Do not stock drugs in the refrigerator which do not require storage in the refrigerator.)

59. Stocking the drugs in the refrigerator that require storage in the refrigerator. Yes / No
(Stock drugs in refrigerator which require storage in the refrigerator.)

60. Whether food items are stored in the refrigerator Yes / No
(Do not stock food items in refrigerator.)

61. Whether oily injections are stored in the refrigerator? Yes / No
(Do not stock oily injections in the refrigerator.)

62. Switching off the refrigerator at night. Yes / No
(Do not switch off the refrigerator at night and maintain desired temperature of the drugs.)

63. Air conditioner / Cooler 
(Do not install cooler; however, an air conditioner is advisable to maintain the temperature of drugs.) 

64. Stocking the drugs in their original containers. Yes / No
(Always stock the drug in the original container of that drug.)

65. Stocking the drugs in racks (Retail) raised platforms (Wholesale) Yes / No
(Stock the drugs in racks or raised platforms.)

66. Stocking the drugs on the floor. Yes / No
(Do not stock the drugs directly on the floor.)

67. Homeopathic medicines are stocked separately. Yes / No
(Stock the homoeopathic medicines separately.)

68. “Homeopathic medicines” written on the rack. Yes / No
(write “Homeopathic medicines” on the rack.)

69. Ayurvedic medicines are stocked separately. Yes / No
(Stock the Ayurvedic medicines separately.)

70. “Ayurvedic medicines” written on the rack. Yes / No
(write “Ayurvedic medicines” on the rack.)

71. Veterinary drugs are stocked separately. Yes / No
(Stock the Veterinary drugs separately.)

72. “Veterinary drugs Not for human use” written on the rack. Yes / No
(write “Veterinary drugs Not for human use” on the rack)

73. Expiry drugs found stocked. Yes / No

74. If yes, expiry drugs kept separately. Yes / No
(Stock Expired drugs separately away from the trade stock)

75. “Expired dated drugs Not for Sale” written on the rack. Yes / No
(Write “Expired dated drugs Not for Sale” written on the rack)

76. Correspondence with dealers regarding expired drugs. Yes / No
(Correspondence with dealers regarding expired drugs must be done)

77. Sch-X drugs found stocked. Yes / No
(License must be obtained before dealing in Schedule-X drugs)

78. “Physician samples not for sale” found stocked. Yes / No
(Do not stock and sell “Physician samples not for sale”)

79. “Hospital supply drugs not for sale” found stocked. Yes / No
(Do not stock and sell “Hospital supply drugs not for sale”)

80. Misuse of Intoxicating drugs. Yes / No
(Never sell intoxicating drugs without prescription of a RMP, it may be misused)

81. Vet. Oxytocin Injection found stocked. Yes / No
(Stock and sell Vet. Oxytocin Injection in single blister pack only)

82. Diclofenac Injection for veterinary use found stocked. Yes / No
(Do not Stock and sell Diclofenac Injection for veterinary use and it should not more than 10ml vial)

83. MTP Kit 
(MTP kit is to be used under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 and MTP Rules 2003) 

84. Sildenafil Tablets 
(Sildenafil tablets are to be sold on the prescription of Urologist / Psychiatrist Endocrinologist / Venereologist / Dermatologist only) 

85. Are Infant foods displayed. Yes / No
(Infant foods should not be displayed)

86. ‘Banned Nail Polish Remover’ found stocked. Yes / No
(Do not stock and sell ‘Banned Nail Polish Remover’)

87. “Banned drugs” found stocked. Yes / No
(Never stock and sell ‘Banned drugs’)

88. Whether you sell TB drugs. Yes / No 

89. If Yes, whether you are reporting about TB patient to Civil Surgeon. Yes / No
(You should report details of the TB patient to CS)

90. “Without invoice drugs” found stocked. Yes / No
(Purchase of drugs with invoice only)

91. Whether Essential Narcotics Drugs stocked ? Yes / No

92. If yes, whether you have obtained license on Form-24 ? Yes / No
(Obtain license on Form-24 before stocking and selling of Essential Narcotics Drugs)

93. Dustbin kept for “Clean India Project”. Yes / No
(Keep a dustbin and keep India Clean)

94. Date of last inspection done by Drugs Control Officer 

95. Whether samples have been withdrawn by DCO. Yes / No

96. What was the result of sampled drug. Standard / NSQ

97. Copy of last inspection kept. Yes / No
(Copy of inspection report must be kept)

98. Hydroxychloroquine is in Schedule-H1 now. To download the notification, click here.
(Maintain schedule-H1 record for this drug)

99. 2ply, 3ply surgical masks, N95 masks and hand sanitizers are under Essential Commodities Act 1955 were upto 30–06–2020. To download the notification, click here.

100. Retail prices of 2ply, 3ply surgical mask and Hand sanitizer werefixed upto 30–06–20202 ply surgical mask- not more than Rs. 8/- per piece 3ply surgical mask- not more than Rs. 10/- per piece Hand sanitizer — Rs. 100/- per bottle of 200ml. To download the notification, click here.

101. Is sale license is required for stocking and selling of hand sanitizer ? Yes

102. Is sale license is required for stocking and selling of hand cleanser / Rub / wash ? No

103. Doorstep delivery of drugs: Govt of India has issued Notification No. G.S.R. 220 (E) dt. 26–03–2020 regarding the doorstep delivery of drugs. To download the notification, click here.

104. Sale of some drugs without a prescription of RMP and without the supervision of a Registered Pharmacist. Drugs that are not covered under Schedule H, H1, G, X, nRx, can be sold without a prescription of RMP and without the supervision of a Registered Pharmacist.

105. Whether you have installed CC Camera at your premises? Yes / No

Sign
Date
Name

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Prepared by
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Self Inspection Performa

Checklist for self audit for drug sale units 105 points Prepared by Rakesh Dahiya, SDCO, FDA Haryana

To download the self inspection Performa click below link

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