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EU GMP Annex 1 Revision Could Require Firms to Modify or Replace Cleanrooms

This article was originally published in The Gold Sheet

Executive Summary

Cap crimping provision draws fire as U.S. drug makers worry that EU Annex 1 revision could force expensive cleanroom modifications, even as they join EU manufacturers in applauding the revision's relaxation of requirements for particulate control during the manufacture of sterile drug products

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