Download Ebook Quality Assurance for Biopharmaceuticals
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Quality Assurance for Biopharmaceuticals
Download Ebook Quality Assurance for Biopharmaceuticals
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From the Publisher
Provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. Discusses what systems are needed along with a description of each system and its functions. Leading authorities in the biotechnology industry offer insight and suggestions in order to assure the safety, purity and efficacy of products produced.
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From the Back Cover
Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.
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Product details
Library Binding: 216 pages
Publisher: Wiley-Interscience; 1 edition (June 21, 1994)
Language: English
ISBN-10: 0471036560
ISBN-13: 978-0471036562
Product Dimensions:
6.4 x 0.6 x 9.4 inches
Shipping Weight: 1.3 pounds (View shipping rates and policies)
Average Customer Review:
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Amazon Best Sellers Rank:
#1,987,092 in Books (See Top 100 in Books)
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