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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Annex 1 update: A pharmaceutical industry insider says that while Brexit has slowed the work of EMA guidance development, exceptions are Annex 1 and Annex 21, which are deemed high priority. Word has it that the controversial PUPSIT requirement has been included in the latest draft, and that the annex's next rapporteur will come from the French national competent authority.
Industry groups have raised some concerns regarding the European Commission's proposed revisions to the EU’s good manufacturing practice guidelines. They want Annex 1 better aligned with other regulatory and compendial standards for cleanroom designations and water for injection. They also want the European Commission to eliminate certain filter testing requirements as well as limits for large particles in cleanrooms. Groups are also concerned about the costs of implementing certain proposed contamination controls.
Long-awaited plans to change the EU guideline on manufacturing standards for sterile medicinal products are out for consultation. The proposals were drafted in cooperation with the World Health Organization and the international pharmaceutical inspectorate group, PIC/S, to ensure global alignment of standards.