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

This book examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to i

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

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