PIC/S & EMA consultation

Revision of Annex 1 Manufacture of Sterile Medicinal Products

20 December 2017

How to access a pdf document

In 2015 the Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme (PIC/S) and European Medicines Agency (EMA), issued a concept paper (pdf,97kb) on the revision of Annex 1 of the Guidelines to Good Manufacturing Practice for Medicinal Products – manufacture of sterile medicinal products.

A number of international regulatory agencies, including TGA, have been involved in the revision of Annex 1 to:

  • provide clarity of existing GMP requirements
  • provide guidance for new technologies
  • reflect advances in manufacturing processes, methods and the application of risk-management principles.

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

In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the EC.

Any parties interested in providing input to the consultation process, should provide feedback directly to EC using the template for comments available on the PIC/S website

Feedback should be sent by email to: Sante-Pharmaceuticals-B4@ec.europa.eu with the title: "Targeted Public Consultation – Revision of annex 1 of EU GMP Guide".

Hard copies of submissions may also be sent by post to the following address:

Directorate-General for Health and Food Safety,
Unit SANTE B/4,
BE-1049 Brussels.

The subject line of the letter or email should contain the reference "Targeted Public Consultation – Revision of annex 1 of EU GMP Guide".

When submitting your response, you must include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, you should indicate the name and category (company/business; public authority (local, regional, national, international); NGO; patient organisation; other).  If you represent a company, you should state whether they fall within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).

Please note that this consultation process is not managed by TGA and therefore you are not required to send your submissions to TGA.

Consultation and feedback

If you have any questions or feedback regarding the PIC/S–EMA consultation process on revisions to Annex 1, you can: