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

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality syst

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

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and

Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written