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:
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.