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Delivery item: Word Document
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Please note: We do not deliver hard copies.
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Description
More than 40 pages in length, this self-explanatory PAI protocol for API guides you through the entire PAI preparation process. Similar to the PAI Protocol for DPs, it focuses solely on the specific circumstances of API producers.
Table of Contents:
1. Regulatory documentation
2. Organization/Personnel
3. Quality Documents
4. Facilities
5. Utilities
5.1 Purified water system
5.2 WFI/WFI USP Water System
5.3 Clean steam system
5.4 Gases (compressed air, N2, CO2)
5.5 HVAC (Heat Ventilation Air Conditioning)
6. Manufacturing Equipment
7. Cell Banks for Biotech
8. Development Report
9. Holding time studies
10. Shipping studies
11. Key raw materials and intermediates
12. Manufacturing Process
12.1 Synthesis
12.2 Sieving and milling
13. Analytical testing
13.1 API
13.2 Key intermediates
13.3 Test method validation API
13.4 Test method key intermediates
13.5 Method transfer
13.6 Stability
14. Microbiological testing
14.1 Environmental monitoring
14.2 API
15. Laboratory equipment for:
15.1 IPC
15.2 Release
16. Distribution / Inventory control
17. Contractors/Suppliers
18. Inspections
19. PAI Presentations
20. PAI Organization
21. Post Inspection activities
