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Process Validation In Manufacturing Of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series) |
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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance |
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From Book News, Inc.
Regulatory guidelines of the Food and Drug Administration (FDA), Good Manufacturing Practices (GMP) for Pharmaceuticals, and Good Laboratory Practices (GLP) require fully documented systems. This book/CD-ROM package provides a generic format for a Master Validation Plan, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as a case example. The CD-ROM contains a template for a Master Validation Plan. Information is useful to q... >> |
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Pharmaceutical Biotechnology |
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From Book News, Inc.
This textbook outlines the basic science and clinical use of biotechnology-produced pharmaceuticals. The twenty chapters survey the chemical aspects of (glyco)proteins, the delivery and pharmacokinetic aspects of proteins, and the formulation of registered recombinant proteins. Originally published as Introductory textbook on pharmaceutical biotechnology, the second edition adds a chapter on economic considerations. Distributed by Taylor & Francis.... >> |
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Pharmacology
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