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 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of and changes regularly. See the Directory of published versions


Details about each facility or legal entity involved in the manufacture of the medicinal product. This includes but is not limited to: name, identifier, and location address, for marketing authorization holders, sponsors, regulatory authorities, manufacturers, supplier, test site, packaging site.


OrganizationA company or site that performed a test is a manufacturer


CTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic quality data:

HTML presentation example of synthetic quality data:


See Artifacts Index: Domain Bundle Profiles