Glossary
Supplier qualification
The documented process of evaluating and approving a supplier before relying on its materials and certificates: assessing quality history, auditing where risk warrants, agreeing specifications and reviewing performance at intervals.
Why it matters on a certificate
Every framework that lets a buyer reduce testing ties the concession to supplier qualification: the certificate may stand in for tests only when the supplier's reliability has been established and is periodically confirmed. Certificate review and supplier qualification reinforce each other; consistent, sound certificates are themselves qualification evidence.
A worked example
Before reducing incoming tests on a long-used excipient, a buyer reviews two years of the supplier's certificates, runs full analyses on recent batches and compares the results with the certificates, and records the justification. The reduced regime then rests on evidence, not habit.
Examples are synthetic and illustrative; any limits shown are not the requirements for any particular material.
The COA Validator checks the element this term describes on every certificate it reads, and reports what is present, what is missing and what does not add up.