Publication of revised PIC/S Annex 1

On 19 September 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published the revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products. The revised PIC/S Annex 1 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). This has been a best-in-class model of international co-operation between EC, EMA, WHO and PIC/S.

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.

In view of this updates, manufacturers are expected to understand and familiarize themselves with the content, to assess the impact and gaps with current practices, to put in a plan to address the problems identified and start preparing for compliance now ahead of the 2023 deadline by being proactive and implementing new technologies and processes. The gaps analysis should be comprehensive not only focusing on the revised Annex 1 but should also take into account related changes in other GMP chapters and annexes as well as other regulatory documents.

For more information, please visit PIC/S website (https://picscheme.org)