Wednesday 20 December 2017

Draft EU GMP Annex 1 released

The PIC/S Secretariat has notified that the revised EU-PIC/S GMP Annex 1 on the Manufacture of Sterile Medicinal Products has reached Step 2 of the revision process and on 20 December 2017, the PIC/S and EMA published the draft revision of Annex 1 for public consultation.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

The revised Annex 1 has been prepared in co-operation with the EMA, World Health Organization (WHO), and PIC/S in order to maintain global alignment of standards, and provide assurance of product quality. The document is subject to parallel public consultation by the European Commission (EC), WHO and PIC/S.

Key changes from the earlier PIC/S Annex are:
  • Introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary.
  • Introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes.
  • Restructuring to give more logical flow.
  • Addition of detail to provide further clarity.
The revised Annex 1 is downloadable on the PIC/S website (site link) or via this direct link.

The draft has been formatted with prescribed line and page numbers to support a joint international consultation within TGA, PIC/S, WHO and the EC.

Posted by Dr. Tim Sandle

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