ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 11.7: Retain identified reserve samples of each API batch for the required period, in equivalent or more protective packaging and in enough quantity for two full analyses

What does 11.7 require?

Reserve samples are kept to allow later evaluation of batch quality, not for stability testing. Each API batch should have identified reserve samples kept for one year after the manufacturer's expiry date or three years after distribution, whichever is longer; for APIs with retest dates, for three years after its distribution is complete. Storage should be in the API's own packaging system, or one at least as protective as the commercial pack, and the quantity should cover two complete compendial analyses at minimum or, where there is no monograph, two full specification analyses.