Good Pharmaceutical Manufacturing Practice

Focusing on the comparative analysis of U.S. and European manufacturing regulations, the book provides insights into both the U.S. Current Good Manufacturing Practice and the European GMP guidelines. Drawing from over 40 years of experience, it delves into the rationale behind compliance requirements, covering critical topics such as personnel, documentation, production, and quality control. This comprehensive guide is invaluable for professionals aiming to navigate and expand their pharmaceutical operations internationally.