2. Q4B OUTCOME

The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends tha the official pharmacopoeial texts , Ph . Eur . 2.9.40 .2.1.3 For specific dosage forms which have been indicated in local text in the pharmacopoeias by enclosing the text within the black diamond symbols , application of the Uniformity of Dosage Units test is not considered interchangeable in all ICH regions .The acceptance criteria are harmonized between the three pharmacopoeias .