A documented ongoing testing programme should monitor API stability, with the results used to confirm both storage conditions and the retest or expiry dating. Stability test procedures should be validated and stability-indicating. Stability samples should sit in containers that mimic the commercial pack (for example smaller drums made of the same material). Normally the first three commercial batches should go on the programme to confirm the dating, or fewer if earlier data show the API is stable for at least two years; afterwards at least one batch per year should be added (unless none is made) and tested at least annually. APIs with short shelf lives should be tested more often; for biotechnological or biologic APIs with shelf lives of a year or less, every month for the first quarter and then every three months, with intervals reduced only where data show stability is not compromised. Storage conditions should follow the ICH stability guidelines where appropriate.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.