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Parenteral Drug Association Connecting People, Science and Regulation ®

Release of Annex 1 Manufacture of Sterile Medicinal Products

On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 Manufacture of Sterile Medicinal Products. We would like to invite you to voice your concerns in anticipation of the revision to EU Annex 1.   This is a very important opportunity and your expert insight and effort will be most beneficial to the industry, fellow PDA Interest Group members and the task force developing the PDA comments to this draft.

This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.

The draft and the comment table are posted below.

All comments must be received in the table for consideration by 31Jan2018.

Our goal is to reflect a broad perspective from within our membership, so we would like participation from all members; however, we cannot include all comments in the final PDA submission.

We greatly appreciate your support and participation on this industry wide effort, please send comments to [email protected].