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Industry Groups Raise Concerns About Proposed EU GMP Annex 1 Revisions

 
• By Joanne S. Eglovitch

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.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology

Pharmaceutical industry groups tell the European Commission that while proposed EU GMP Annex I revisions represent an improvement, more work is needed to make them practical to implement. Industry groups want more alignment with other regulatory and compendial cleanroom standards for water for injection (WFI), and cleanroom designations and want to see pre-use/post sterilization integrity testing (PUPSIT) and limits for large particles in cleanroom air eliminated. There are also concerns about the cost of complying.

The European Commission on Dec. 20, 2017, published the proposed Annex 1 revisions, which make significant changes to the EU's good manufacturing practice guideline in relation to sterile medicinal products, includes new environmental standards for cleanrooms, and introduces principles to allow manufacturers of sterile medicinal products to adopt new technologies and innovative processes

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