Description
Book SynopsisThis volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. Insight is given on the safety, purity and efficacy of the products produced.
Table of ContentsOrganization 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.
