Q7A does not have an expectation for a stability program for intermediates other than those
intermediates that are being sold. It does not have an expectation for a retest date for
intermediates other than those that are the being sold. Q7A states in Section 8.2: “Intermediates
held for further processing should be stored under appropriate conditions to ensure their
suitability for use”. What are being asked for here are appropriate conditions. Appropriate in this
case would refer to both conditions and the length of time. It’s not a retest date, it’s not a stability
program, but there is an expectation that you make sure it is okay to use either through past
knowledge or testing prior to use.
If there is concern regarding suitability, it can always be tested just before use. That’s why Q7A
did not include stability testing and applying retest dates or expiry dates to intermediate as an
expectation.
