Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

Organization | A company or site that performed a test is a manufacturer

### 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