1. INTRODUCTION
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2. Q4B OUTCOME
2.1 Analytical Procedures The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 2.9.17. Test for Extractable Volume of Parenteral Preparations, JP 6.05 Test for Extractable Volume of Parenteral Preparations, and the section in USP Injections General Chapter entitled "Volume in Containers” can be used as interchangeable in the ICH regions.
2.2 Acceptance Criteria The acceptance criteria are the same in the three pharmacopoeias.
3.TIMING OF ANNEX IMPLEMENTATION
When this annex has been implemented (incorporated into the regulatory process at ICH Step 5) in a region, it can be used in that region. Timing might differ for each region.
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, and/or prior approval procedures should be handled in accordance with established regional regulatory mechanisms pertaining to compendial changes.
4.2 FDA consideration:
Based on the recommendation above, and with reference to the conditions set forth in this annex, the pharmacopoeial texts referenced in Section 2.1 of this annex can be considered interchangeable. 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.
Source: ICH, Pls check the follow
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