For APIs, Q7A does not refer to holding times but rather to retest dates and expiry dates, mostly
retest dates. Holding times are generally applied to intermediates, with the exception of those that
may be marketed or distributed. For an intermediate that’s distributed, Q7A expects a retest or
expiry date, but for intermediates being held in house for further processing, the expectation is for
holding times. Retest dates and expiration dates are not an expectation for intermediates, but
rather holding times.
