The revised EU & PIC/S GMP Annex 1 - CCN Webinar 2022 10 26

At last we have the regulatory guidance we have been waiting for. For those have been following the saga, after the launch more than five years ago, the EU Commission in cooperation with PIC/S presented a first draft for public comment in 2017. There were an unsurprising deluge of more than 6000 comments on this draft under the rapporteurship of Andrew Hopkins, then of the UK’s MHRA. Andrew moved on, and under French leadership a second draft for public comment was published in 2020. This also received numerous comments concerning technical issues, lack of clarity and errors. A final version arrived on 25th August 2022, and although better is still consider to be rather poor with technical issues, poor English in abundance. However, we have to live with it as there are no ground for rejection or appeal; and a good start is to understand some important changes.
There are some important deadlines.
The new EU Annex 1 will come into force on 25 August 2023, one year after publication in Eudralex Volume 4.
There isn’t any published news yet about the PIC/S implementation.
The new guidance on product transfer in and out of lyophilizers has a two year period for implementation, probably due to the magnitude of changes that will be required (Physical, operational and procedural).

[@Mohammed-mw8wg]

Excellent presentation