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

This book provides guidance on developing a GMP-oriented industry with trained and skilled personnel and manufacturing products that meet GMP and regulatory requirements. It covers basic quality concepts and the elements of vendors assessment, qualification, and approval required by pharmaceutical educational institutions and professional certification bodies.

\n Format: Hardback
\n Length: 152 pages
\n Publication date: 13 December 2021
\n Publisher: Taylor & Francis Ltd
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The pharmaceutical industry is a highly regulated sector that requires strict adherence to Good Manufacturing Practices (GMP) to ensure the safety and efficacy of pharmaceutical products. GMP regulations are set by regulatory agencies such as the FDA in the United States and the EMA in Europe, and they cover all aspects of drug production, from raw materials to finished products.

To develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements, it is essential to understand the basic quality concepts and the elements of vendor assessment, qualification, and approval required by pharmaceutical educational institutions and professional certification bodies. This book 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.

The book covers topics such as quality management systems, quality control, quality assurance, and quality improvement. It also includes ready-to-use regulatory documentation, such as letters of commitment, questionnaires, and SOPs, required for API and packaging materials contracts. The material can be easily tailored to incorporate changes to add in-house vendor qualification requirements.

In conclusion, this book is a valuable resource for readers and front-line health care products manufacturers, R&D management, and biotech laboratories who want to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. It provides comprehensive guidance on quality management systems, quality control, quality assurance, and quality improvement, and includes ready-to-use regulatory documentation to enhance the GMP within the industry.

\n Weight: 398g\n
Dimension: 161 x 241 x 19 (mm)\n
ISBN-13: 9781032030883\n \n