The European Commission on 20 February launched a targeted consultation on a second proposed revision of the EU good manufacturing practice guideline’s Annex I for sterile drug products, last revised in 2009.
EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.
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