Description

Book Synopsis
This 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 Contents
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.

Quality Assurance for Biopharmaceuticals

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    A Hardback by Jean F. Huxsoll

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      Publisher: John Wiley & Sons Inc
      Publication Date: Publication Date: 08/07/1994
      ISBN13: 9780471036562, 978-0471036562
      ISBN10: 0471036560
      Also in:
      Chemistry Genetic engineering Industrial quality control

      Description

      Book Synopsis
      This 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 Contents
      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.

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