Section 12.6 states, “Systems and processes should be periodically evaluated to verify that they
are still operating in a valid manner. Where no significant changes have been made to the system
or process, and a quality review confirms that the system or process is consistently producing
material meeting its specifications, there is normally no need for revalidation”.
Revalidation of an API process may be warranted if the change in the API starting materials is
deemed significant. If the Impurity Profile of the Starting Material is significantly different from that
previously validated, this may warrant additional validation studies to ensure that the API process
can eliminate any increase in or new impurities in the API.
