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Process validation includes laboratory optimization, pilot-plant introduction, and process implementation on manufacturing scale, as well as monitoring batches after implementation and continuously improving the manufacturing processes. There are many opportunities to change and optimize operations. The background information in this contribution describes current guidance and terminology for validation, including the integration of validation over the development lifecycle of drug substances. Various examples illustrate challenges and success stories of implementation as part of the overall approach to process validation.
Current Practices of Process Validation for Drug Substances and Intermediates
Anderson’s Process Solutions, 7400 Griffin Lane, Jacksonville, Oregon 97530, United States, Creative Innovation Partners, 1971 Western Avenue, Albany, New York 12203, United States, and Rib-X Pharmaceuticals Inc., 300 George Street, New Haven, Connecticut 06511, United States
Org. Process Res. Dev., 2011, 15 (1), pp 162–172
DOI: 10.1021/op1002825
Publication Date (Web): December 21, 2010
Copyright © 2010 American Chemical Society
* To whom correspondence should be addressed: E-mail: nganderson@dishmail.net., †
Creative Innovation Partners., ‡Rib-X Pharmaceuticals Inc.
http://pubs.acs.org/doi/abs/10.1021/op1002825
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