Medicinal products

First targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4

Period of consultation

From 20 December 2017 to 20 March 2018.

Objective of the consultation

Annex 1 was first published in 1971, since then it has undergone a number of targeted updates but, until now it has not undergone a full review. 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. Key changes are:

  • Introduction of new sections: scope, utilities, Environmental and process monitoring sections and glossary
  • Introduction of QRM Principles
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity.

Acknowledgment

In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the proposed revised version was prepared in cooperation with WHO and PIC/S. The document will be subject to parallel public consultation by WHO and PIC/S.

Contributions

DG SANTE received the following contributions:

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Specific privacy statement

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