With a written program that assigns risk by ingredient, defines what evidence is required at each risk level, and re-evaluates on a stated interval. A supplier list with certificates attached is not a qualification program.
Risk-tier the ingredients, not the vendors
Botanical extracts, imported raw materials and ingredients with a history of economically motivated adulteration warrant more evidence than a commodity excipient from a long-standing source. Tiering by ingredient rather than by vendor keeps the program proportionate.
Define the evidence for each tier
- Written specification agreed with the supplier, including test methods
- Identity testing performed on receipt, or a documented exemption rationale
- Supplier questionnaire, third-party certification, or on-site audit by tier
- Change notification commitments in the quality agreement
- Defined re-evaluation interval and the trigger events that reset it
Make performance feed back into the tier
Out-of-specification receipts, late change notifications and repeat documentation errors should move a supplier up a tier automatically. Programs that never change a supplier's status after the initial approval are not managing risk; they are recording it.
Reviewed by the named consultant. Last updated July 14, 2026. General information only — not regulatory or legal advice for a specific situation.