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.
Related:
- List of SOP for Pharmaceutical Industry
- List of SOP for Pharmaceutical Quality Assurance
- GMP Facility Design and 10 Golden Rules
