What to do if the medicinal product monograph includes a test for disintegration?

Answer:

If a disintegration test is described in an individual medicinal product monograph, a suitable product-specific test has to be proposed by the applicant for routine quality control to confirm batch-to-batch consistency. This test must be described in the MAA for submission to the competent authority. The demonstration of the suitability of the test has to be made by the applicant to the satisfaction of the competent authority, as is already the case for a dissolution test.