PAI Protocol For Drug Products - GMP Checklist

More than 40 pages in length, this self-explanatory PAI protocol for drug products guides you through the entire PAI preparation process. It was created to systematically identify the strengths, opportunities, weaknesses and threats associated with organisation, personnel, quality documents, facilities, utilities such as water systems, clean steam and HVAC, manufacturing and analytical equipment, development reports, holding-time studies, key excipients, manufacturing processes, analytical and microbiological testing including method transfer, method validation and stability, packaging operations and contractors/suppliers. At various points, the checklist also queries the current status of corrective actions relating to previous inspections and regulatory documentation that is yet to be completed. The PAI protocol will enable you to identify shortcomings at your site during the early stages of PAI preparation work, usually from 12 months before file submission, and will give you the opportunity to resolve these shortcomings and finalise pending plans and reports in an organised and timely manner. Crucial elements of the PAI protocol are the four key monitoring milestones – 6, 3 and 0 months before file submission and one week before inspection. The progress of PAI preparation work can be monitored at any time.

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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. Development Report
8. Holding time studies
9. Shipping studies
10. Key Excipients
11. Manufacturing Process
12. Analytical testing
12.1 Drug Product
12.2 Devices
12.3 Primary packaging material
12.4 Test method validation DP
12.5 Method transfer DP
12.6 Stability
13. Microbiological testing
13.1 Environmental monitoring
13.2 Drug Product
14. Laboratory equipment for:
14.1 IPC
14.2 Release
15. Packaging
16. Distribution / Inventory control
17. Contractors/Suppliers
18. Inspections
19. PAI Presentations
20. PAI Organization
21. Post Inspection activities

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Please note: We do not deliver hard copies.


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