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This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications.
List of contents
1. Finding and Partnering Active Pharmaceutical Ingredients Vendor. 2. Selection of API Vendors and the impacts on Drug products. 3. Approach, Team formation and Planning. 4. Site Standard Operating Procedure for vendors approval. 5 Vendors evaluation records list. 6. Vendors Document check list. 7. Declaration and Quality Commitment. 8. Self-evaluation Questionnaire. 9. Self Evaluation Questionnaire Sterile Bulk Mfg. 10. Quality Agreement. 11. Covering letter for Supplier. 12. Quality Agreement for Generic APIs. Chapter 13. API Audit checklist TOC. 14. Audit report. 15. Cell lines Vendors Selection for Biological products. 16. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
About the author
Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Summary
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications.
