PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release
PIC/S is considering adopting Annex 16 of EU GMP and harmonizing its requirements. The new document will be called Authorized Person and Batch Release.
Following the revision of Annex 16 in 2016, PIC/S has been discussing whether to transpose Annex 16 in order to harmonize international requirements related to batch release and has now started step 2 of the adoption process which involves consultation of PIC/S Member Authorities with stakeholders.
This consultation will be launched on 15 June 2021 for a period of 3 months.
For the original document, please see link below.