EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

 
• By Joanne S. Eglovitch

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology
EU's GMP Annex I Revision For Sterile Drugs Maintains PUPSIT • Source: Shutterstock

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