Good Pharmaceutical Manufacturing Practice 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Sharp, John 作者

CRC Pr I Llc

译者

2004-10 出版日期

520 页数

$ 338.94 价格

HRD

丛书系列

9780849319945 图书编码

Good Pharmaceutical Manufacturing Practice 在线电子书图书标签: Gmp

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发表于2024-12-24

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Good Pharmaceutical Manufacturing Practice 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

Good Pharmaceutical Manufacturing Practice 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Good Pharmaceutical Manufacturing Practice 在线电子书图书描述

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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