4. CONSIDERATIONS FOR IMPLEMENTATION

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 regional regulatory mechanisms pertaining to compendial changes .However , FDA might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product , irrespective of the origin of the method .