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EU Defends Plans To Keep 'PUPSIT' Testing In Revised EU GMP Annex 1

 
• By Joanne S. Eglovitch

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.

Many of microorganisms colonies after complete of incubation period from the test of purified water by the membrane filtration method.

As the EU revises an annex to its GMP guideline that outlines expectations for sterile drug manufacturing, a key official backs plans to retain a requirement in the annex for pre-use/post-sterilization integrity testing (PUPSIT) despite continued opposition from industry.

The EU now expects to issue the oft-delayed Annex 1 revision early next year.

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