Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the Pharmaceutical Sciences)

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9780849339721: Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the Pharmaceutical Sciences)
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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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"What is especially valuable about these chapters is the degree of explanation which the authors have brought, and the appropriateness of the examples which they have used. "There are ample illustrations....deserves to be read and digested by anyone whose job it is to keep an operation on the proper side of the law." -Pharmaceutical Development and Technology (for fourth edition) "The chapters are clearly and concisely written, and provide the reader with the current regulations and practical discussions relating to interpretation of the guidelines.... "I am pleased to add this edition to my bookshelf!" -European Journal of Pharmaceutics and Biopharmaceutics (for fourth edition) "an invaluable text.help[s] any individual or student learn the application of the CGMPs." -Pharmaceutical Research (for fourth edition) "excellent in presentation and language.a value to anyone interested in drug manufacture." -American Journal of Pharmaceutical Education (for fourth edition)

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