Glossary
Specification
The agreed list of tests, references to analytical methods and acceptance criteria that a material or product must meet to be considered acceptable for its intended use. A batch conforms when its results meet the specification's criteria.
Why it matters on a certificate
Every result on a certificate only means something relative to a specification: the buyer's, the supplier's, or a pharmacopoeial monograph. Reviews go wrong when the printed limits are quietly a different specification from the one the buyer believes applies. Establishing which specification governs is the first question of any certificate review.
A worked example
A buyer's specification for a raw material requires an illustrative assay limit of "not less than 99.0%". The supplier's certificate prints "not less than 98.5%" and reports 98.7%. The batch passes the supplier's printed limit and fails the buyer's specification: the same number, two different verdicts.
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.