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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
March 01, 2003
The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.