Pharmaceutical Process Validation, Second Edition

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Ira R. Berry, Robert A. Nash
Taylor & Francis, Jan 29, 1993 - Science - 648 pages
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An aid for scientists and technicians in the pharmaceutical and allied industries, in the selection of procedures and approaches that may be employed to achieve a successful outcome with respect to product performance and process validation. The present edition brings readers up to date on what has happened in the eight years since publication of the first edition, with the number of chapters nearly doubled to reflect growing interest in topics not previously covered, such as validation of water systems, cleaning validation, computer systems validation, and equipment validation. Several special topics have also been added, including validation of lyophilized products, validation of inhalation aerosols, and recent trends in process validation. Annotation copyright by Book News, Inc., Portland, OR

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Contents

Introduction
xiii
The Regulatory Basis for Process Validation
1
Organizing for Validation
9
Copyright

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