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

Manufacturing Process

Manufacturing process description and details about unit operations, process parameters, and in-process controls.

Product

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Ingredient	The active ingredient (stelbatalol) or the ingredients that make up the drug substance or product
Substance Definition	Details about the substance associated with the product ingredients, or those that participate in the steps of the manufacturing process
Plan Definition	Describes the manufacturing process protocol. Includes "action" steps, parameters, and output criteria
DeviceDefinition	Information about devices/equipment used in the manufacturing
DocumentReference	(not shown) Link to images, about process steps for example

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.3 Manufacture
  • 3.2.P.3.3 Description of Manufacturing Process and Process Controls

XML and JSON examples of synthetic quality data:

• Product Manufacturing Process example XML
• Product Manufacturing Process example JSON

HTML presentation example of synthetic quality data:

• Product Manufacturing Process

Substance

Resources

SubstanceDefinition	Details about the substance being manufactured, or those that participate in the steps of the manufacturing process
PlanDefinition	Describes the manufacturing process protocol. Includes "action" steps, parameters, and output criteria

Examples

CTD section samples (PDF):

• 3.2.S.2 Manufacture
  • 3.2.S.2.2 Description of Manufacturing Process and Process Controls

XML and JSON examples of synthetic CTD data:

• Substance Manufacturing Process example XML
• Substance Manufacturing Process example JSON

HTML presentation example of synthetic CTD data:

• Substance Manufacturing Process - 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