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PAI protocol for drug products
Checklist

Description:
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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	Price:	199.– EUR * (appr. 257.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



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		Editable Word Document You will be able to enter your personal data into the Word Document. Please notice: We do not deliver hard copies.



	Further details: 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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PAI protocol for drug products Checklist

PAI protocol for drug products
Checklist