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Название: Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
Автор: Sharp J.
Bridging the gap between US regulations and European Good Manufacturing Practice guidelines, Sharp (European Journal of Parenteral and Pharmaceutical Sciences) explains the essence of material from the US 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). He compares the principal requirements in both systems, and explores the reasoning behind these requirements outlines ways to comply with them. Coverage encompasses personnel and facilities management as well as manufacturing. The book will be useful for those who wish to expand their pharmaceutical business