After some delay and disagreement, the revision of Annex 1 on the Manufacture of Sterile Medicinal Products of the PIC/S and EU GMP Guides has now progressed to the next stage of public consultation.
Compiled by the European Medicines Agency (EMA), the World Health Organization (WHO) and PIC/S (Pharmaceutical Inspection Co-operation Scheme, an organisation worldwide, which exclusively deals with GMP) the document is designed to maintain global alignment of standards, while at the same time achieving assurance for the highest quality. As such it is subject to parallel public consultation by the European Commission, WHO and PIC/S. The consultation period will last three months, from 20 December 2017 to 20 March 2018.
Key changes from the earlier Annex 1 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.
In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the European Commission (EC). To download the consultation document and the template required to submit comments or for any queries in relation to this public consultation, please refer to the EC website by clicking here.
The consultation document is also published on the PIC/S website under the section Drafts on the page Publications.