This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutica

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern c