When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeia texts that are referenced in Section 2.1 of this annex , any change notification , variation .And/or prior approval procedures should be handled in accordance with established regiona regulatory mechanisms pertaining to compendial changes .In accordance with the conditions set out in this annex , as fulfilling the requirements for compliance with the Ph . Eur . Chapter , Sterility : 2.6.1 . , on the basis of the declaration of interchangeability made above .
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