Pharmaceutical Vendors Approval Manual : A Comprehensive Quality Manual for API and Packaging Material Approval book cover
1st Edition

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




ISBN 9781032030883
Published December 13, 2021 by CRC Press
170 Pages 2 B/W Illustrations

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Book Description

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. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.

This book

  • provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements
  • covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies
  • provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry
  • provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract

Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements.

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

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(s)

Biography

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