Add Impurity element to MedicinalProductDefinition

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    • Type: Change Request
    • Resolution: Persuasive
    • Priority: Medium
    • FHIR Core (FHIR)
    • R5
    • Biomedical Research & Regulation
    • DomainResource
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      Agreed on call 28th July

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      Agreed on call 28th July
    • Peter Bomberg/Catherine Hosage Norman: 19-0-0
    • Enhancement
    • Compatible, substantive
    • R5

      Background:  PQ/CMC has a requirement to capture drug product impurities.  These impurities are substances.

      Request adding a new element called impurity to MedicialProductDefinition

      Element name: impurity  (0..*)  References SubstanceDefinition Resource

      Definition:  Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products. [Source: Adapted from ICH Q6A and ICH Q6B ]

            Assignee:
            Rik Smithies
            Reporter:
            Smita Hastak
            Catherine Hosage Norman, Rik Smithies, Smita Hastak, vdesai
            Watchers:
            1 Start watching this issue

              Created:
              Updated:
              Resolved: