9/10 November 2021
With Step 5, the harmonisation regarding the use of pharmacopoeial methods for sterility test has been completed. For several years, the ICH has been working on harmonising the requirements of the Pharmaocopoeias in the regions of the EU, the U.S. and Japan. Based on the evaluation by the Q4B Expert Working Group (EWG), the ICH Steering Committee has recommended that the official pharmacopoeial texts, Ph. Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests, can be used as interchangeable in the ICH regions subject to the conditions detailed below. Testing conditions for medical devices - such as sutures - are outside the scope of the ICH recommendation.
As always with ICH harmonisation processes, there is an addition, stating that the FDA may request a demonstration that the chosen method is acceptable and suitable for a specific material or product, irrespective of its origin. The European Union states: "For the European Union, the monographs of the Ph. Eur. have mandatory applicability. Regulatory authorities can accept the reference in a marketing authorisation application, renewal or variation application citing the use of the corresponding text from another pharmacopoeia as referenced in Section 2.1, 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."
For more details please see the complete document "ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter".