The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends that the official pharmacopoeial texts , Ph . Eur . 2.6.1 .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 .The acceptance criteria are harmonized between the three pharmacopoeias .
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