According to the definition, material should not be used after the expiry date. The original intent of this definition in ICH Q7 was that expired API should not be used in drug product formulation. It may be acceptable to reprocess [ICH Q7, Section 14.2] or rework [ICH Q7, Section 14.3] the expired API where the API manufacturer has all related historical GMP documentation and additional stability data on the reworked or reprocessed API. There may be registration/filing considerations that are beyond the scope of ICH Q7 in addition to the GMP considerations.
