Glossary category
Quality and documentation
Terms describing the documentary record of a manufactured material.
Terms
11 documents
Table 1. Terms in the quality and documentation category.
| Term | Definition |
|---|---|
| Batch traceabilityLot traceability | The linkage between a certificate and the specific batch supplied, by batch identifier and date. A certificate that cannot be linked to the material in hand is a specimen document. |
| Certificate of analysisCOA | The document accompanying a batch, reporting the determinations made and the results obtained. Its value depends entirely on which fields it carries and whether the methods are named. |
| Good manufacturing practiceGMP · cGMP | A regulated system of controls over manufacture, in which a claim of compliance is meaningful only where an inspecting authority is named. An unverified compliance claim is a marketing statement. |
| ISO 17025 | The international standard for the competence of testing laboratories. Accreditation is granted for named tests within a defined scope; a laboratory accredited for one determination is not thereby accredited for another. |
| Minimum data standard | The Institute’s specification of the fields a certificate must carry for a purity or content claim to be interpretable. Fields are classified as critical or recommended; a certificate missing a critical field cannot support the corresponding claim. |
| Not assessed | In an Institute supplier dossier, an attribute the Institute did not examine. Carries no implication about the attribute and is recorded so that a reader can distinguish it from a failed verification. |
| Not verified | In an Institute supplier dossier, a claim for which the Institute has looked for supporting documentation and not found it. Distinct from not assessed. |
| Research use onlyRUO | A supply designation indicating that material is not manufactured under a marketing authorisation and is not approved for human or veterinary use in any jurisdiction. A designation about regulatory status and not a statement about quality. |
| Sample provenance | The record of where an analysed sample came from and who selected it. A supplier-selected sample and an independently purchased one are different classes of evidence and the Institute labels them as such. |
| Third-party testing | Analysis performed by a laboratory independent of the supplier. Stronger evidence than a supplier-issued certificate, and weaker than analysis of an independently purchased sample, because the supplier chose which material to submit. |
| Verified | In an Institute supplier dossier, a determination supported by documentation the Institute has examined. Verification is of the documentation and never of the product, which the Institute has not tested. |