4. CONSIDERATIONS FOR IMPLEMENTATION

4.1 General consideration : When sponsors or manufacturers change their existing methods to the implemented Q4Bevaluated 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 Particulate Contamination : Sub-visible Particles : 2.9.19 . .