Pharmaceutical Process Validation, Second Edition
Marcel Dekker Inc (Publisher)
Published on 29. January 1993
Book
Hardback
648 pages
978-0-8247-8777-6 (ISBN)
Description
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
More details
Series
Language
English
Place of publication
New York
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
ISBN-13
978-0-8247-8777-6 (9780824787776)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Book
03/2003
3rd Edition
CRC Press
€317.40
Shipment within 15-20 days
Content
The regulatory basis for process validation, Bernard T. Loftus; organizing for validation, J. Patrick Jeater et al; sterilization validation of sterile products - fundamentals, Michael J. Akers and Neil R. Anderson; validation of sterile products - recent developments, Karl Hoffman; validation of solid dosage forms, Jeffrey S. Rudolph; process validation and quality assurance, Carl B. Rifino; prospective process validation, Allen Y. Chao et al; retrospective process validation, Chester J. Trubinski; validation of water systems, Ward Johnson; cleaning validation, P.Y. McCormick and Leo F. Cullen; equipment validation, Jacek Bak et al; process validation of raw materials, Ira R. Berry; analytical methods validation, Louis A. Pasteelnick; computer systems validation, James E. Krueger; validation of lyophilized products, Edward H. Trappler; validation of inhalation aerosols, Scott Bozzone; analysis of retrospective production data using quality control charts, Peter H. Cheng and John E. Dutt; analysis of multivariant data, Stephen T. Horhota and Carolyn L. Aitken; current concepts in process validation, John Y. Lee; validation termilogy, Kenneth G. Chapman.