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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Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.
Despite improvements, latest EU GMP Annex 1 revision draws another round of objections to PUPSIT filter testing provision.
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