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Industry Consortium Developing Best Practices For Meeting Proposed EU GMP PUPSIT Requirement

Executive Summary

The pharmaceutical industry is grappling with the fact that, despite their concerns of additional risk, pre-use, post-sterilization integrity testing (PUPSIT) may remain an expectation in the EU's Annex 1. A consortium has been established to help companies address filtration related risks that PUPSIT is designed to mitigate and to develop a best practice guide on PUPSIT to help manufacturers comply with the EU's Annex 1.


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