This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, 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