List of Production SOP in Pharmaceutical Industry


Pharmaceutical Standard Operating Procedure (SOP) provides step-by-step guidance for the personnel to perform a specific process or operation. Pharmaceutical production SOP ensure that production operations are performed consistently to maintain the quality and control of processes and products.

1. SOP for Preparation, review & approval of Batch  Manufacturing Record

2. SOP for Document Checking

3. SOP for Gowning and de-gowning procedure

4. SOP for First change procedure

5. SOP for Second change procedure

6. SOP for Procedure for Audit trail review

7. SOP for Procedure for manual activities/ operation

8. SOP for Cleaning of dispensing area

9. SOP for Reservation of Materials 

10. SOP for Dispensing of raw materials

11. SOP for Receiving of dispensed raw materials

12. SOP for Dismantling and cleaning of Compression Machine

13. SOP for Dismantling & Cleaning of Metal detector

14. SOP for Dismantling & Cleaning of tablet printing machine

15. SOP for Dismantling and cleaning of Capsule Filler

16. SOP for Dismantling & Cleaning of Capsule Deduster

17. SOP for Dismantling and cleaning of Capsule Polishing Machine

18. SOP for Visual inspection and sorting of Tablets and Capsules

19. SOP for Dismantling and Cleaning of Granulation suite

20. SOP for Dismantling and cleaning of Blender

21. SOP for Dismantling and Cleaning of Coating machine

22. SOP for Dismantling and Cleaning of Colloid Mill

23. SOP for Dismantling and Cleaning of Sifter and vacuum Conveyor

24. SOP for Cleaning of Utensils

25. SOP for Cleaning of Solution Preparation Vessel, Stirrer and Starch Paste Preparation Vessel

26. SOP for Storage, Issues and Handling of Tooling

27. SOP for Handling of Logbook in Production Area

28. SOP for Frequency and method of cleaning production corridor

29. SOP for Preparation, issue and disposal of disinfectant, Sporicidal and cleaning solution

30. SOP for Frequency and method of cleaning manufacturing rooms including primary packaging area

31. SOP for Procedure for recovery of Intermediate, Bulk and Finished Products

32. SOP for Production Operation Close Down And Resume Procedure Before And After Long Shut Down

33. SOP for Cleaning of cleaning accessories

34. SOP for Cleaning of internal Pallets, Cage Trolley, SS Stand, Trolley Table, hand trolley, hydraulic hand trolley & Tool box

35. SOP for Dispensing of solvents & solution preparation

36. SOP for Storage of dispensed materials, sieved materials, granules, bulk Tablets and Capsules 

37. SOP for Transfer of bulk Tablets and Capsules from intermediate store to the primary Packaging area

38. SOP for Daily accuracy check of production balances

39. SOP for Cleaning of  plastic containers for raw materials and bulk products 

40. SOP for Controlling spillage of raw Material and Liquid

41. SOP for Cleaning of Balances

42. SOP for Repairing and Polishing of Punches & Dies

43. SOP for Cleaning of IBCs Discharge Station

44. SOP for Preparation of User Requirement Specifications

45. SOP for Disposal of wastes Generates from Production area  

46. SOP for Cleaning of Sugar Coating Syrup Preparation Vessel

47. SOP for Cleaning of Transport  Vessel

48. SOP for Cleaning of Starch Paste Preparation Vessel

49. SOP for Cleaning of rubber shoes and slipper  used in primary & secondary area

50. SOP for Control of labels

51. SOP for Cleaning of punch and die

52. SOP for Storage monitoring and issue of tools from cleaned tools store

53. SOP for Preparation of 70 % Isopropyl Alcohol 

54. SOP for Handling of Spillage in Manufacturing Area

55. SOP for Procedure for handling and Control of label, display  used in production area

56. SOP for Reconciliation of product (Granules, Core tablet, Coated tablet, Capsule)

57. SOP for General rules for equipment cleaning 

58. SOP for Cleaning procedure for general pharmaceutical plant area 

59. SOP for Cleaning of hose pipe

60. SOP for Procedure for Hold Time Study of Granules, Tablet (Core and Coated), Capsule, Coating solution and solution for Granulation

61. SOP for Cleaning, use and activities of cleaning store Janitor store 

62. SOP for Dress change procedure for technical zone

63. SOP for Sampling procedure for % of loss on drying determination  

64. SOP for Cleaning of wheeled container

65. SOP for Handling of trial run in production floor

66. SOP for Area clearance of Primary Manufacturing Area

67. SOP for Standard Operating procedure of SAP ERP system for Production Planning

68. SOP for Cleaning Procedure of IBCs and visual inspection of cleaned IBC

69. SOP for Transfer of damaged Tablets tooling, damaged spare parts, broken buckets and lids

70. SOP for Cleaning of IBC wash station

71. SOP for Cleaning of Washing and Drying machine

72. SOP for Cleaning of friability tester

73. SOP for Cleaning of standard weight bar

74. SOP for Dismantling and cleaning of drying cabinet

75. SOP for Cleaning  of X-ray illuminator

76. SOP for Cleaning of Vernier calipers

77. SOP for Cleaning of  FBD filter bag and filter socks

78. SOP for Startup Tableting Process

79. SOP for Receipt, numbering usage and destruction of FBD filter bag and filter socks

80. SOP for Gowning and de-gowning procedure for dispensing booth

81. SOP for Frequency and method of cleaning of wash bay in manufacturing area

82. SOP for Dismantling and Cleaning  of Multi Mill

83. SOP for Handling of Purchase Requisition

84. SOP for Creation, Edit, Delete, and Download of Recipe

85. SOP for Handling of Manufacturing and Packaging Operations During Unplanned Power Failure

86. SOP for Controlling the users and user level security of PLC based equipment

87. SOP for Time Synchronization of Equipment and Instruments of Manufacturing Area

88. SOP for Handling of automated hand sanitizer dispenser

89. SOP for Handling of Silicon Tube

90. SOP for Handling of Gaskets and Seals in Production Area

91. SOP for Qualification procedure, Identification of skill matrix & on-the-job monitoring for production personnel.

92. SOP for Cleaning of Personnel Protective Equipment’s

93. SOP for Receipt, Numbering, Storage, usage and Destruction of miscellaneous item used in production manufacturing

94. SOP for Dismantling and cleaning of roller compactor

95. SOP for Handling of Dust Cap

96. SOP for Nitrogen gas cylinder handling procedure.


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