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 https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Organizations

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.

Resources

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.3 Manufacture
  • 3.2.P.3.1 Manufacturer(s)
• 3.2.S.2 Manufacture
  • 3.2.S.2.1 Manufacturer(s)

XML and JSON examples of synthetic quality data:

• Organization example XML
• Organization example JSON

HTML presentation example of synthetic quality data:

• Drug Substance or Product Organizations - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

Profiles

See Artifacts Index: Domain Bundle Profiles