By: Charlotte Enghave Fruergaard, ISPE Annex 1 Commenting Group

A concept paper issued by European Medicines Agency (EMA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 2 February 2015, addresses the need to update Annex 1 (Eudralex Volume 4: Annex 1 Manufacture of Sterile Medicinal Products) of the EU GMP guide. Annex 1 is common to the member states of the European Union/European Economic Area as well as to the participating authorities of the PIC/S.

Recently, ISPE established a steering group to comment on Annex 1 from a technical point of view. The purpose of the group is to collect and collate comments from all ISPE members around the world and to work collaboratively with other associations and groups (i.e. A3P and Sterile Products Processing COP) to reduce duplication.

If you have experience using Annex 1 (i.e. manufacturing, engineering, quality, compliance, vendor, etc.) and would like to contribute to a better version of Annex 1, please forward your comments using the template found within the concept paper to by no later than 9 March 2015.

General comments and specific concerns on Annex 1 may include:

  • What is missing in Annex 1 that you would like to see in there?
  • What areas do you think requires revision and what would the expected change be?

Comments on Annex 1 must reference the item number and line number. General comments should, as necessary, be accompanied by a rational. In order to be accepted for comment by the ISPE Technical Review Team, specific line number comments must detail the proposed change and have an associated rational. To help you develop your comments, please review the commenting guidelines and examples.

In your submission, please also state if you are willing to participate in the technical review prior to the release of a new draft guideline (October 2015).

On behalf of the society’s leaders and the ISPE Annex 1 Commenting Group, I look forward to your comments and suggestions.

For more information about ISPE’s regulatory affairs, please visit the ISPE website.