Quality Assurance for BiopharmaceuticalsISBN: 978-0-471-03656-2
Hardcover
216 pages
June 1994
 This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 10-15 days delivery time. The book is not returnable.
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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 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.
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.
Related Titles
General Pharmaceutical & Medicinal Chemistry
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