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 falling outside the stated scope of the assessment, which the Institute did not examine. Carries no implication about the attribute and is recorded so that scope can be told apart from finding. |
| Not verified | A rubric state for a claim the Institute has looked for supporting documentation for and not found. It is defined so that it can be told apart from not assessed, which records that the Institute did not look. No supplier in the current assessment set carries an attribute in this state; the state applies to material submitted about suppliers on which no dossier has been opened. |
| 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. |