European Commission unveils long-awaited revision to guideline on sterile drug manufacturing
Building off a previous revision in 2007, the European Commission on Thursday released its latest update to its guideline on manufacturing sterile drugs.
The Commission said its updated 58-page Annex 1, which provides technical guidance on the principles and guidelines around sterile drug GMPs, follows the recommendation of the GMP/GDP Inspectors Working Group and the PIC/S committee to reflect changes in both regulatory and manufacturing.
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