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Significant Revisions To Annex 1 Cleanroom Standard Soon To Be Released

 
• By Joanne S. Eglovitch

MHRA inspector and rapporteur Andrew Hopkins anticipates that the long-awaited revision of Annex 1 on environmental monitoring standards for cleanrooms will soon be released and offers a preview of some of the changes.

The revision of the international sterile manufacturing guideline known as Annex 1 is expected to be released in July, Andrew Hopkins, rapporteur for the revision’s drafting group, announced at the Parenteral Drug Association’s conference on Annex 1 in Berlin, Germany, on June 12.

Hopkins, who is an inspector with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), said that revision retains the controversial requirement that manufacturers conduct pre-use post sterilization testing...

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