The company should decide and justify the decision of which method to use. All test methods for stability studies [ICH Q1A] should be validated and demonstrated to be stability indicating prior to use [ICH Q7, Section 11.51]. Any changes to stability test methods should be documented. Applicability of the changes to the existing stability studies should be assessed and may require filing in accordance with regional requirements for post-approval changes [ICH Q7, Section 13.11].
