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Annex 1 Consultation document issued

20 December 2017   (0 Comments)
Posted by: Tamsin Marshall
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Consultation on the revision of annex 1, on manufacturing of sterile medicinal products


Period of consultation

From 20 December 2017 to 20 March 2018.


Objective of the consultation

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 20December2017, the PIC/S and EMA published the draft revision of Annex 1 for public consultation.


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 thePIC/S websiteclick below for documentand has been formatted with prescribed line and page numbers to support a joint international consultation within PIC/S, WHO and the EC.


Click here for download


Have your say. 

Why not come along to the joint PHSS & PQG Conference Discussion EU GMP Annex 1 Draft Revision Insight 

12th March 2018

Click here for more information

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