Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

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Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, this book comparatively presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide). Based on the author's 40+ years experience, it offers special consideration of the reasoning behind the requirements, with specific regards to compliance methods. Topics also 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.

aseptic process validation, aseptic fill room, predicate rule requirements, drug product containers, other status decision, two regulatory documents, batch packaging instructions, internal lot number, parametric release, internal code reference, sterilization process cycle, printed packaging materials, sterile medicinal products, returned drug products, accordance with written procedures, products manufacturing areas, manufacturing authorisation, significant intermediate stages, manufacturing authorization, manufacturing formula, such written procedures, bioburden reduction, ware validation, nonsterile products, appropriate written procedures