John Sharp - Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Category	Uncategorized
ISBN10	0849319943
Tags	compliance good manufacturing pharmaceutical practice
Description	John Sharp - Good Pharmaceutical Manufacturing Practice: Rationale and Compliance Pages:288 \| PDF \| Interpharm Press Inc (30. Oktober 2004) \| ISBN \| 4.5 MB 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. or

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