2. Q4B OUTCOME

The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends that the official pharmacopoeial texts , Ph . Eur . 2.9.3 .2.1.5 Validation studies should be conducted to demonstrate that the test results are not adversely affected if the thermometer is to remain in the dissolution vessel per regiona good manufacturing practice ( GMP ) .Acceptance criteria should be specified in the application dossier .