PIC/S has announced a focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)

Geneva, 20 September 2019

This revision is subject to a focused stakeholder consultation which includes both consultation questions and an opportunity to comment on:

    –    a draft Annex 2A (PS/INF 25/2019 (Rev. 1)): Manufacture of Advanced Therapy Medicinal Products for Human Use; and
    –    a draft Annex 2B (PS/INF 26/2019 (Rev. 1)): Manufacture of Biological Medicinal Substances and Products for Human Use. 

For more details: https://picscheme.org/en/news/22/-revision-of-pic-s-gmp-guide