Quality Assurance for Biopharmaceuticals
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More About This Title Quality Assurance for Biopharmaceuticals
English
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.
English
Jean F. Huxsoll is the author of Quality Assurance for Biopharmaceuticals, published by Wiley.
English
Organization of Quality Assurance (J. Huxsoll).
Coming into GMP Compliance (C. Orelli).
Documentation Systems (C. Brochard).
Validation (D. Colton).
Quality Assurance (QA) of Production Materials for Biotechnology(D. Miller).
Quality Assurance (QA) of Analytical Methods--Biochemical (F.Bogdansky).
Applied Data Analysis, Sampling Methodologies, and StatisticalValidation Techniques (G. Swartz).
Environmental and Safety Programs for Biotechnology (M.Sigourney).
Regulatory Issues--United States (C. Spencer).
Regulatory Issues--Europe (R. Wikberg-Leonardi & D.Mulder).
Regulatory Issues--Japan (R. Rousell & E. Greene).
Abbreviations.
Appendices.
Index.
Coming into GMP Compliance (C. Orelli).
Documentation Systems (C. Brochard).
Validation (D. Colton).
Quality Assurance (QA) of Production Materials for Biotechnology(D. Miller).
Quality Assurance (QA) of Analytical Methods--Biochemical (F.Bogdansky).
Applied Data Analysis, Sampling Methodologies, and StatisticalValidation Techniques (G. Swartz).
Environmental and Safety Programs for Biotechnology (M.Sigourney).
Regulatory Issues--United States (C. Spencer).
Regulatory Issues--Europe (R. Wikberg-Leonardi & D.Mulder).
Regulatory Issues--Japan (R. Rousell & E. Greene).
Abbreviations.
Appendices.
Index.
