GMP/GDP Inspectors Working Group (GMP/GDP IWG) Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

The concept paper open for public consultation since 8th May 2025 until 8th July 2025, aims to outline the rationale, objectives, and proposed changes for updating Part IV – GMP specific to ATMP of the good manufacturing practice (GMP) guide Eudralex Volume 4 following the revision of Annex 1 which came into operation in August 2023.