Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

Erfan Syed Asif

• Publisher: CRC Press
• Year: 2021
• Print ISBN: 9781032038131
• eBook ISBN: 9781000510027
• Edition: 1
• Topic: Business
• Subtopic: Pharmacology
• Index: Business

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

• Cover
• Half-Title
• Title
• Copyright
• Dedication
• Contents
• Preface
• Author
• Chapter 1 Finding and Partnering Active Pharmaceutical Ingredients Vendor
• Chapter 2 Selection of API Vendors and the Impacts on Drug Products
• Chapter 3 Approach, Team Formation, and Planning
• Chapter 4 Site Standard Operating Procedure for Vendors Approval
• Chapter 5 Vendors Evaluation Records: Buyer Company’s Name
• Chapter 6 Document Status Checklist
• Chapter 7 Declaration and Quality Commitment
• Chapter 8 Manufacturing Facility Self-Evaluation Questionnaire
• Chapter 9 Sterile Bulk Manufacturing Facility Self-Evaluation Questionnaire
• Chapter 10 Quality Agreement
• Chapter 11 Covering Letter for Supplier
• Chapter 12 Quality Agreement for Generic APIs
• Chapter 13 API Audit Checklist
• Chapter 14 Audit Report
• Chapter 15 Cell Lines Vendors Selection for Biological products
• Chapter 16 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
• Index