PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)
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Recommendation
24/25 September 2024
incl. Case Studies “Entering the Clean Area” and “Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“
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
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