 Quality Assurance for Biopharmaceuticals
ISBN: 978-0-471-03656-2
Hardcover
216 pages
June 1994
US $135.00
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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.
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.
