Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals
Author :
Publisher : CRC Press
Total Pages : 418
Release :
ISBN-10 : 9781420020939
ISBN-13 : 1420020935
Rating : 4/5 (935 Downloads)

Book Synopsis Good Manufacturing Practices for Pharmaceuticals by : Joseph D. Nally

Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.


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FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11