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Industry Groups Raise Concerns About Proposed EU GMP Annex 1 Revisions

Executive Summary

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.

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