Good Pharmaceutical Manufacturing Practice Rationale and Compliance
Good Pharmaceutical Manufacturing Practice Rationale and Compliance by John Sharp, published by Taylor & Francis on October 15, 2004, spans 520 pages and is presented in English. This book addresses the critical aspects of Good Manufacturing Practice (GMP) for pharmaceutical products, focusing on the most influential regulatory statements from both U.S. and European guidelines. Drawing on over 40 years of experience in the pharmaceutical industry, the author provides insights into the essential practices necessary for compliance and effective implementation.
Readers will find a comprehensive examination of GMP principles, including personnel management, documentation, and quality control. The book delves into the reasoning behind regulatory requirements and offers practical guidance for adhering to them. Topics such as production processes, self-inspection, and recalls are also covered, making this work a valuable resource for professionals looking to enhance their understanding of pharmaceutical manufacturing standards and expand their business in the global market.
Official synopsis Publisher
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.
This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant 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.
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