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Quality assurance for biopharmaceuticals

Author: Jean F Huxsoll
Publisher: New York : Wiley, ©1994.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
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  Read more...
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Additional Physical Format: Online version:
Huxsoll, Jean F.
Quality assurance for biopharmaceuticals.
New York : Wiley, ©1994
(OCoLC)609187679
Online version:
Huxsoll, Jean F.
Quality assurance for biopharmaceuticals.
New York : Wiley, ©1994
(OCoLC)624379049
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Jean F Huxsoll
ISBN: 0471036560 9780471036562
OCLC Number: 29548174
Notes: "A Wiley-Interscience publication."
Description: 206 pages : illustrations ; 24 cm
Contents: 1. Organization of quality assurance / J.F. Huxsoll --
2. Coming into GMP compliance / C.M. Orelli --
3. Documentation system / C. Brochard --
4. Validation / D.R. Colton --
5. Quality assurance (QA) of production materials for biotechnology / D.H. Miller --
6. Quality assurance (QA) of analytical methods --
biochemical / F.M. Bogdansky --
7. Applied data analysis, sampling methodologies, and statistical validation techniques / G.R. Swartz --
8. Environmental and safety programs for biotechnology / M. Sigourney --
9. Regulatory issues --
United States / C.L. Spencer --
10. Regulatory issues --
Europe / R. Wikberg-Leonardi and D. Mulder --
11. Regulatory issues --
Japan / R.H. Rousell and E.L. Greene.
Responsibility: Jean F. Huxsoll.
More information:

Abstract:

This volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological  Read more...

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