Quality assurance for biopharmaceuticals
By: Jean F. Huxsoll.
Publisher: Wiley
Published: 1994
Place of publication: New York
Language: eng
Number of pages: 206
Subjects: Pharmaceutical biotechnology -- Quality control.
Description: 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.
Notes: Includes bibliographical references and index.
"A Wiley-Interscience publication".