5190287
9780849339721
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.Nally, Joseph D. is the author of 'Good Manufacturing Practices for Pharmaceuticals A Plan for Total Quality Control Manufacturer to Consumer', published 2006 under ISBN 9780849339721 and ISBN 0849339723.
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