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 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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