4. CONSIDERATIONS FOR IMPLEMENTATION

4.1 General consideration : When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in Section 2.1 of this annex , any change notification , variation .In accordance with the conditions set out in this annex , as fulfilling the requirements for compliance with the Ph . Eur . Chapter , Test for Extractable Volume of Parenteral Preparations : 2.9.17 . .