2. Q4B OUTCOME

The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends that for tablets and capsules , the official pharmacopoeial texts , Ph . Eur . 2.9.1 .Disintegration , can be used as interchangeable in the ICH regions subject to the conditions detailed below .2.1.1 For tablets and capsules larger than 18 millimeters ( mm ) long for which a different apparatus is used , the Disintegration Test is not considered to be interchangeable in the three regions .