Manufacturing and labelling of raw materials for use b API manufacturers is outside the scope of ICH Q7. As such, retest and expiry dates, as defined in ICH Q7, do not strictly apply to raw materials and may be used in a different manner by the raw material supplier. Expiry date, as defined in the glossary of [ICH Q7, Section 20], applies specifically to the API. API manufacturers may re-evaluate [ICH Q7, Section 7.5] and then use a raw material after the ‘expiry date’ or ‘retest date’, based on an appropriate scientific and risk-based justification (e.g., understanding of material attributes, testing, and stability). Similar justifications may be used to extend the date by which the material should be re-evaluated. It is the responsibility of the API manufacturer to ensure the raw materials are appropriate for the intended use at the time of use.
