PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)

Recommendation

18/19 June 2024
Copenhagen, Denmark

Environmental Monitoring
Compliant and Reasonable

On 25 August 2022, the EU Commission published the long-awaited revised version of Annex 1 "Manufacture of Sterile Medicinal Products". Almost simultaneously with the EU Commission, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) also published the revised Annex 1 (Manufacture of Sterile Medicinal Products) to the Guide to Good Manufacturing Practice for Medicinal Products on 9 September 2022.

The PIC/S Annex 1 is identical to the EU GMP Guide Annex 1 - with the exception of some minor corrections in the wording.

Background

The PIC/S started the revision of Annex 1 in 2014 with the decision to establish a corresponding working group. This group, together with the relevant IWG (Inspectors Working Group) and WHO, formed a joint group to revise Annex 1. A first round of public commenting followed in 2017 - with over 6.000 comments; a second round with still 2.000 comments followed in 2021. In March / April 2022, the final document was submitted to the EMA IWG on GMDP and the PIC/S Committee for approval and was adopted.

Source: PIC/S Annex 1