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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
James P. Stumpff, RPh, is principal consultant with Parexel International, firstname.lastname@example.org.
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.