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
Resource Fabrication Guide
Domain 12 • Station 2
Resource Fabrication Guide
This guide details how to map source data from your LIMS, QMS, and ERP systems into the core FHIR resources required for the Stability Study Bundle.
Follow these recipes to ensure your instances pass profile validation.
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1. Master Data & Entities
Organization
Testing Lab & Manufacturer
Purpose: Identifies entities responsible for manufacturing and testing.
Source: ERP / MDM
| Field | Example FSH Mapping |
|---|
| identifier | * identifier.value = "3003040516" |
| type | * type = $pharm-org-type#drug-substance-manufacture |
| name | * name = "AAA Molybdenum Products, Inc." |
| contact.address | * contact.address.city = "Broomfield" |
Substance / Medication
Batch Information
Purpose: Identifies the specific manufactured batch being tested.
Source: ERP / MES
| Field | Example FSH Mapping |
|---|
| code | * code.extension.valueReference = Reference(...) |
| batch.lotNumber | * batch.lotNumber = "33445" |
| batch.extension | * batch.extension[...url="manufacturingDate"].valueDateTime = "2020-06" |
2. Study Protocol & Setup
PlanDefinition
Study Protocol
Purpose: Overarching stability study design, grouping all activities.
Source: QMS Protocol
| Field | Example FSH Mapping |
|---|
| title | * title = "Stability Study Protocol for Stelbat" |
| status | * status = #active |
| action | * action[0].definitionCanonical = Canonical(...) |
ActivityDefinition
Test Schedule
Purpose: Defines *when* tests are performed (schedule time-points).
Source: QMS Protocol
| Field | Example FSH Mapping |
|---|
| timingTiming | * timingTiming.event = "2021-03-01" |
| observationRequirement | * observationRequirement = Reference(ObsDef) |
ObservationDefinition
Test Methods & Limits
Purpose: Defines the assay, test method, and acceptance criteria limits.
Source: LIMS / QMS
| Field | Example FSH Mapping |
|---|
| code | * code = $loinc#3142-7 |
| method | * method.text = "Karl Fischer Titration" |
| qualifiedInterval | * qualifiedInterval.range.high = 2.0 '%' |
SpecimenDefinition
Storage Conditions
Purpose: Defines environmental conditions for sample storage.
Source: QMS Protocol
| Field | Example FSH Mapping |
|---|
| typeTested.preference | * typeTested.preference = #preferred |
| typeTested.handling | * typeTested.handling.instruction = "25°C/60% RH" |
3. Execution & Results
Purpose: Represents physical samples pulled and placed in storage.
Source: LIMS
| Field | Example FSH Mapping |
|---|
| collection | * collection.collectedDateTime = "2020-12-01" |
| processing.description | * processing[1].description = "25°C/60% RH" |
Purpose: The actual results generated by the lab at a specific time-point.
Source: LIMS
| Field | Example FSH Mapping |
|---|
| status | * status = #final |
| value[x] | * valueQuantity = 1.5 '%' |
| hasMember | * hasMember[0] = Reference(...) |
| specimen / subject | * specimen = Reference(Specimen) |
DiagnosticReport
Final Report
Purpose: Packages all results, protocols, and conclusions into one report.
Source: QMS / LIMS
| Field | Example FSH Mapping |
|---|
| status | * status = #final |
| basedOn | * basedOn = Reference(PlanDef) |
| result | * result[0] = Reference(Obs) |
| conclusion | * conclusion = "Complies..." |
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