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- catalog abstract "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.".
- catalog contributor b6407893.
- catalog created "c1994.".
- catalog date "1994".
- catalog date "c1994.".
- catalog dateCopyrighted "c1994.".
- catalog description "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.".
- catalog description "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.".
- catalog description "Includes bibliographical references and index.".
- catalog extent "206 p. :".
- catalog hasFormat "Quality assurance for biopharmaceuticals.".
- catalog identifier "0471036560 (alk. paper)".
- catalog isFormatOf "Quality assurance for biopharmaceuticals.".
- catalog issued "1994".
- catalog issued "c1994.".
- catalog language "eng".
- catalog publisher "New York : Wiley,".
- catalog relation "Quality assurance for biopharmaceuticals.".
- catalog subject "1994 G-901".
- catalog subject "615/.19 20".
- catalog subject "Biotechnology.".
- catalog subject "Drug Industry.".
- catalog subject "Pharmaceutical biotechnology Quality control.".
- catalog subject "QV 771 H986q 1994".
- catalog subject "Quality Control.".
- catalog subject "RS380 .H88 1994".
- catalog subject "Technology, Pharmaceutical.".
- catalog tableOfContents "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.".
- catalog title "Quality assurance for biopharmaceuticals / Jean F. Huxsoll.".
- catalog type "text".