WHO | Inspections | Prepare your documents for verification during the inspection

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World Health Organization
  
The checklist here:
1. Organogram
2. Job descriptions
3. Quality policy (e.g. quality manual)
4. Validation policy (e.g. validation master plan or programme)
5. Raw material specifications (for specific products)
6. Packaging material specifications
7. Manufacturing formula and method masters
8. Packing instructions master
9. Batch manufacturing records (verification against master documents)
10. SOP index
11. SOP: self-inspection
12. SOP: recalls
13. SOP: complaints plus records
14. SOP: batch number allocation
15. SOP: planned preventive maintenance
16. SOP and record: planned preventive maintenance of specific equipment
17. SOP: training (plus record of personnel)
18. SOP: environmental monitoring plus records
19. SOP: water sampling and testing plus records

20. Validation protocol and report for specific products

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