La Vague 76 / January 2023
The final official version of Annex 1 (Manufacture of Sterile Medicinal Products – Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use), dated 22 August 2022, was published on 25 August 2022. This final version was keenly awaited by manufacturers and follows a long revision process initiated in 2015 by a working group made up of GMP/GDP inspectors and PIC/S representatives (Inspection Working Group – IWG) and a consultation process led by different associations such as A3P, PDA, PHSS, ISPE, EFPIA …
