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 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.

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.