Good Pharmaceutical Manufacturing Practice

More about the book

Focusing on the intersection of U.S. and European manufacturing regulations, this guide provides a comprehensive overview of both US cGMPs and the EU GMP guidelines. With over forty years of expertise, the author delves into critical topics such as personnel management, documentation, production processes, and quality control. The book aims to clarify the rationale behind regulatory requirements, making it an essential resource for professionals looking to expand their pharmaceutical operations globally.