Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology | Version: 2.0.0-ballot | |||
Active as of 2024-12-04 | Computable Name: PqcmcImpurityClassificationTerminology | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.36 |
Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
References
Generated Narrative: ValueSet pqcmc-impurity-classification-terminology
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
Code | Display |
C176816 | Degradation Product |
C185190 | Elemental Impurities |
C176815 | Residual Solvent |
C134001 | Inorganic |
C176812 | Process Related/Process |
C185192 | Leachables |
C176813 | Product Related |
C92081 | Microbiological |
Generated Narrative: ValueSet
Expansion based on supplement PQ-CMC-FDA NCIt Hieararchy Supplement v2.0.0-ballot (CodeSystem)
This value set contains 8 concepts
Explanation of the columns that may appear on this page:
Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
Code | The code (used as the code in the resource instance) |
Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
Definition | An explanation of the meaning of the concept |
Comments | Additional notes about how to use the code |