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

## Identification

Details about the drug substance and drug product nomenclature; structure; physicochemical properties; and manufacture.

### Product

#### Drug Product

##### Resources

Composition | Narrative text section(s)
MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
ManufacturedItemDefinition | Information about the physical packaged medication item, such as a tablet or capsule
Composition | Textual information about the product

##### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.2 Pharmaceutical Development
  - 3.2.P.2.2 Drug Product

XML and JSON examples of synthetic quality data:

- Product Identification example XML
- Product Identification example JSON

HTML presentation example of synthetic quality data:

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

#### Drug Product Microbiological Attributes

##### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
Medication | Describes the batches of the product that underwent testing
DiagnosticReport | Contains all rest results as a group and captures conclusions
Observation | The results of a specific test mentioned in the Observation Definition

##### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.2 Pharmaceutical Development
  - 3.2.P.2.5 Microbiological Attributes

XML and JSON examples of synthetic quality data:

- Product Microbiological Attributes Report example XML
- Product Microbiological Attributes Report example JSON

HTML presentation example of synthetic quality data:

- Product Microbiological Attributes - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

#### Drug Product Excipients

##### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
Ingredient | The excipients that make up the drug product
Organization | The company that manufactures the excipients
Substance Definition | Chemical or biological details about substance(s) associated with the ingredient

##### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.4 Control of Excipients
  - 3.2.P.4.5 Excipients of Human or Animal Origin
  - 3.2.P.4.6 Novel Excipients

XML and JSON examples of synthetic quality data:

- Product Excipients example XML
- Product Excipients example JSON

HTML presentation example of synthetic quality data:

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

### Substance

#### Drug Substance General Properties

##### Resources

Substance Definition | Properties of the substance

##### Examples

CTD section synthetic source data samples (PDF):

- 3.2.S.1 General Information
  - 3.2.S.1.3 General Properties

XML and JSON examples of synthetic quality data:

- Substance General Properties example XML
- Substance General Properties example XML

HTML presentation example of synthetic quality data:

- Substance General Properties - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

#### Drug Substance: Elucidation of Structure

##### Resources

SubstanceDefinition | The substance being characterized
Substance | Identifying information about an actual batch of substance (an instance)
PlanDefinition | Describes the tests for the characterization
ObservationDefinition | Each individual stability test and their acceptance criteria
Observation | The results of a specific test mentioned in the ObservationDefinition
DiagnosticReport | Contains all rest results as a group and captures conclusions
Organization | (not illustrated above): The company/site that performed the testing or manufacturing

##### Examples

CTD section synthetic source data samples (PDF):

- 3.2.S.3 Characterisation
  - 3.2.S.3.1 Elucidation of Structure and Other Characteristics

XML and JSON examples of synthetic quality data:

- Substance Characterisation example XML
- Substance Characterisation example XML

HTML presentation example of synthetic quality data:

- Substance Characterisation: Elucidation of Structure - 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