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

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

eCTD 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 CTD data:

• Organization example XML
• Organization example JSON

HTML presentation example of synthetic CTD data:

• Drug Substance or Product Organizations

Profiles

See Artifacts Index: Organizations