Jean F Huxsoll

Quality Assurance for Biopharmaceuticals

• Gebundenes Buch

Produktbeschreibung

Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.

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Produktdetails

• Verlag: Wiley
• Seitenzahl: 216
• Erscheinungstermin: 22. Juni 1994
• Englisch
• Abmessung: 240mm x 161mm x 17mm
• Gewicht: 501g
• ISBN-13: 9780471036562
• ISBN-10: 0471036560
• Artikelnr.: 21628319

Autorenporträt

Jean F. Huxsoll is the author of Quality Assurance for Biopharmaceuticals, published by Wiley.

Inhaltsangabe

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.