Quality Assurance for Biopharmaceuticals

ISBN-13: 9780471036562 / Angielski / Twarda / 1994 / 216 str.

Jean F. Huxsoll

Opis

This volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. The author discusses what systems are needed, and gives a detailed 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 the products produced.

Spis treści

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 Statistical Validation 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.