EU Defends Plans To Keep 'PUPSIT' Testing In Revised EU GMP Annex 1
An EU regulatory official is undeterred by pleas from industry to modify a requirement that manufacturers conduct pre-use, post-sterilization integrity testing of filters for sterile drugs under EU GMP Annex 1. The original annex required PUPSIT testing and the revision also is expected to require it. The revised annex has been repeatedly delayed, and now is expected early next year.
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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.
Industry Groups Raise Concerns About Proposed EU GMP Annex 1 Revisions
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.
PDA Survey Shows Compliance Can Trump Science In Aseptic Processing
PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.