News about GMP/cGMP

23.09.2022

PIC/S: Publication of Revised GMP Annex 1

PIC/S: Publication of Revised GMP Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).


The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO).

Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.


Source:

PIC/S News: Publication of revised PIC/S Annex 1


 

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