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Industry Makes Final Arguments Against PUPSIT Before EC Decides On EU GMP Annex 1 Revision

 
• By Joanne S. Eglovitch

Despite improvements, latest EU GMP Annex 1 revision draws another round of objections to PUPSIT filter testing provision.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology
Industry Groups Give Final Verdict On Proposed Annex 1 Revision • Source: Shutterstock

In a "targeted consultation" that could be the last opportunity to object before a major revision of EU guidance on manufacturing sterile drugs goes final, industry has again raised concerns about a proposal to require a filter testing strategy that it says could enable the very contamination it is intended to prevent.

Although the filter testing provision continued to draw complaints from industry groups asked to provide feedback, at least one of...

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