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Quality Assurance For Biopharmaceuticals Book

Quality Assurance For Biopharmaceuticals
Quality Assurance For Biopharmaceuticals, 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 descript, Quality Assurance For Biopharmaceuticals has a rating of 3.5 stars
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Quality Assurance For Biopharmaceuticals, 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 descript, Quality Assurance For Biopharmaceuticals
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  • Quality Assurance For Biopharmaceuticals
  • Written by author Jean F. Huxsoll
  • Published by Wiley, John & Sons, Incorporated, June 1994
  • 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 descript
  • 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 descript
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Book Categories

Authors

Preface
Contributors
1Organization of quality assurance1
2Coming into GMP compliance15
3Documentation system27
4Validation45
5Quality assurance (QA) of production materials for biotechnology61
6Quality assurance (QA) of analytical methods - biochemical75
7Applied data analysis, sampling methodologies, and statistical validation techniques91
8Environmental and safety programs for biotechnology119
9Regulatory issues - United States137
10Regulatory issues - Europe151
11Regulatory issues - Japan171
Abbreviations189
Appendices193
Index197


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Quality Assurance For Biopharmaceuticals, 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 descript, Quality Assurance For Biopharmaceuticals

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Quality Assurance For Biopharmaceuticals, 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 descript, Quality Assurance For Biopharmaceuticals

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