. Long Awaited Draft to Annex 1 on Sterile Manufacturing Published

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Long Awaited Draft to Annex 1 on Sterile Manufacturing Published

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

Since the first publication took place in 1971, Annex 1 on sterile manufacturing has undergone a number of focused updates.  The draft has undergone extensive revision by regulatory body to incorporate latest updates.

In order to introduce new technologies and innovative processes, the revision of Annex 1 is performed and intends to add more clarity. Quality Risk management is added to allow a more logical flow of information.

The key changes are:

The proposed revised version was prepared in cooperation with WHO and PIC/S.

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