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
Business Use Cases
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This implementation guide defines resources to support many scenarios. The following use cases facilitate understanding of how to use and apply this guide. These examples assume the manufacturer owns or has access to a data repository housing test results structured per this IG.
Select a Use Case
Stability (New to 18 months)
A sponsor plans to create a new stability study for a medicinal product with a proposed shelf-life of 18 months at 5 °C, with supporting stability data.
1
Using the G-SRS as a reference, build SubstanceDefinition, Ingredient, MedicinalProductDefinition, and Medication resources. These form a reusable library that can be versioned and reused across use cases.
2
Create a library of tests as ObservationDefinition resources (e.g., Identification, Assay by HPLC, Dissolution). Group all tests into an ActivityDefinition resource.
3
Develop the stability study
Create a PlanDefinition resource to define study objective, time point description, and statistical model.
4
Send stability study to testing lab
Bundle the stability study and send it to the testing lab via RESTful API. The lab receives, parses, and conducts the study.
5
Return results to the sponsor
The lab creates Observation resources for each test result and a DiagnosticReport for conclusions. Results are bundled and returned via API.
6
The sponsor's system receives the Bundle via API, parses it, notifies personnel, and displays the results.
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Develop final study report
Create a final DiagnosticReport with conclusions. The complete stability study can be transformed into any output format acceptable to national regulators.
Stability Update (18 to 24 months)
A sponsor plans to update the shelf life from 18 months to 24 months at 5 °C, with supporting stability data.
1
Acquire previously used stability study data
Pull up the previously submitted Stability Bundle from the pharmaceutical quality data repository.
2
Update Medication, Stability Study, Specimen Storage, and Stability Test Result resources. The repository creates new versions for tracking and lifecycle management.
3
Transform the Bundle into an acceptable submission format and submit to the health authority.
4
Respond to regulator questions
If the health authority requests additional data (e.g., microbiological testing), update the Specification Bundle and resubmit.
5
The regulator approves the specification change and shelf-life extension. Update the dataset status in your Quality repository.
Test Specification Change
A sponsor plans to execute a change in the drug substance identity method and acceptance criteria, sending the change request to a CMO.
1
Acquire data from the library
Access the ObservationDefinition resources (analytical procedures and test methods) from the public repository via RESTful API.
2
Select from common compendial procedures (HPLC, cell-based assay, gene-based assay) or prefabricated specifications. Edit ObservationDefinition parameters as needed.
3
Send specification to CMO & receive results
Package the specification into a Bundle and send to the CMO via API. Test results are returned in the same FHIR format.
4
Transform the data to meet national requirements and submit to the health authority for review.
Facility Change
A sponsor wants to document a change to a testing facility's address in the Organization resource.
1
Acquire Organization data from the library
Download the Organization resource from the quality data library.
2
Update the Organization resource(s) — new name, alias, address, or additional identifiers (e.g., SPOR ID, FEI, DUNS).
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Tip: The Organization profile can leverage auto-population from external databases such as EMA's OMS or U.S. FDA's Data Dashboard, reducing manual entry and driving consistency.
3
Send or receive Organization data
The updated Organization resource(s) can be sent to an external party (CMO, regulator, or others) using RESTful API.
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Propose a change