Pharmaceutical Quality (Industry)
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Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Analytical Procedures

Details about test methods used to analyze substances and products, including compendial and non-compendial testing.

Product

Resources

MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
SubstanceDefinitionSubstances used during the analysis process
PlanDefinitionDescribes the analysis process
SpecimenDefinitionDescribes the storage conditions and duration for each test
Observation DefinitionEach individual analysis test and acceptance criteria; also used to group tests

Examples

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation examples of synthetic CTD data:

Substance

Resources

SubstanceDefinitionSubstances to be analyzed and also ones used during the analysis process
PlanDefinitionDescribes the analysis process
DeviceDefinitionDevices/equipment used during testing
SpecimenDefinitionDescribes the storage conditions and duration for each test
Observation DefinitionEach individual analysis test and acceptance criteria; also used to group tests

Examples

CTD section samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML rendering of synthetic CTD data:

Profiles

See Artifacts Index: Analytical Procedure