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.
James P Stumpff
Advertisement
James P. Stumpff, RPh, is principal consultant with Parexel International, [email protected].
Articles by James P Stumpff
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.
Advertisement
Latest Updated Articles
Remote Inspections - Lessons LearnedMarch 15th 2022
Succeeding With OOS and Root-Cause InvestigationsJuly 1st 2020
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA Duloxetine Recall Highlights Generic Manufacturing Quality Gaps
2
Germany Pharma Tariff Threat: What Manufacturers Need to Know
3
PharmTech Weekly Roundup—June 19, 2026
4
Why the First Generic Single-Dose Flu Antiviral Approval Matters
5