Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval
Author:   Erfan Syed Asif
Publisher:   Taylor & Francis Ltd
ISBN:  

9781032030883


Pages:   152
Publication Date:   13 December 2021
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval


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Full Product Details

Author:   Erfan Syed Asif
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.453kg
ISBN:  

9781032030883


ISBN 10:   1032030887
Pages:   152
Publication Date:   13 December 2021
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table 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

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Author Information

Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.

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