| Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
| resourceType | ValueSet |
| id | pqcmc-test-subcategory-terminology |
| canonical | http://hl7.org/fhir/us/pq-cmc/ValueSet/pqcmc-test-subcategory-terminology |
| version | 0.1.15 |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulatory WG |
| name | PqcmcTestSubCategoryTerminology |
| title | Test Sub-Category Terminology |
| date | 2023-07-17T03:00:13+00:00 |
| experimental | true |
| description | Terminology used to qualify the information pertaining to test sub-categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. |
| jurisdictions | us |
| Usages |
|
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
| Code | Display |
| SUBC2 | active ingredient |
| SUBC3 | amino acid content |
| SUBC4 | bioburden |
| SUBC5 | counterion content |
| SUBC6 | excipient |
| SUBC7 | host cell dna |
| SUBC8 | percent conjugate |
| SUBC9 | purity |
| SUBC10 | nucleic acid content |
| SUBC11 | solvate content |
| SUBC12 | total protein |
| SUBC13 | Cell and Gene therapy product characterization assay |
| SUBC16 | Uniformity of dosage unit |
| SUBC17 | Uniformity in containers |
| SUBC20 | Description/Appearance |
| SUBC21 | Odor |
| SUBC22 | Color of solution |
| SUBC23 | Clarity of Solution |
| SUBC29 | Metal detection |
| SUBC45 | Individual Weight |
| SUBC46 | Group/Average Weight |
| SUBC47 | Weight variation |
| SUBC48 | Individual Fill Weight |
| SUBC49 | Group/Average Fill Weight |
| SUBC50 | Target group weight gain % |
| SUBC51 | Shell weight |
| SUBC52 | Orifice location |
| SUBC53 | Orifice diameter |
| SUBC54 | Orifice depth |
| SUBC55 | Drilled side (single or double) |
| SUBC56 | Number of orifices |
| SUBC57 | Ribbon thickness |
| SUBC58 | Ribbon density |
| SUBC59 | Seam thickness |
| SUBC60 | Lock length |
| SUBC61 | Tablet/Capsule length |
| SUBC62 | Tablet/Capsule diameter |
| SUBC63 | Tablet thickness |
| SUBC83 | Glycosylation |
| SUBC84 | Thrombin Peptide Map |
| SUBC85 | Sialylation |
| SUBC86 | Amidation |
| SUBC87 | Deamidation |
| SUBC92 | Specified identified impurity |
| SUBC93 | Specified unidentified impurity |
| SUBC94 | Unspecified impurity |
| SUBC95 | Total impurities |
| SUBC96 | Total Unknown Impurities |
| SUBC97 | Identified impurity under IT that is monitored as unspecified |
| SUBC98 | elemental impurity |
| SUBC99 | impurity chemical |
| SUBC100 | Impurities/Degradation Products/Related Substances |
| SUBC101 | residual solvent |
Produced 08 Sep 2023