Good Pharmaceutical Manufacturing Practice Rationale and Compliance

Bridging the gap between US and European Good Manufacturing Practice guidelines, this book comparatively presents the major substance of both the “US Current Good Manufacturing Practice for Finished Pharmaceutical Regulations” and the European “Guide to Good Manufacturing Practice for Medicinal Products.” It offers special consideration of the reasoning behind the requirements, with specific regards to compliance methods. Topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.