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.
Industry Makes Final Arguments Against PUPSIT Before EC Decides On EU GMP Annex 1 Revision
Despite improvements, latest EU GMP Annex 1 revision draws another round of objections to PUPSIT filter testing provision.
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