On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018.

Since then, Annex 1 on sterile manufacturing has undergone a number of targeted updates. But the multitude of regulatory changes finally required the most extensive and thorough revision since the first publication took place in 1971.

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 key changes in short:

  • Introduction of new sections: scope, utilities, Environmental and process monitoring sections and glossary
  • Introduction of QRM Principles
  • Introduction of new technologies such as closed single-use and disposable systems
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity.

The proposed revised version was prepared in cooperation with WHO and PIC/S. If you are interested in taking part in the public consultation you will find detailed information here.

We will shortly provide you with a detailed analysis of the Draft Annex 1 in our Newsletter Logfile.

Source: EC: Public Consultation