Stability Study

Pharmaceutical Quality (Industry)
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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

Profiles

Domain 12 • Stability Study

Stability studies are critical for establishing the shelf-life and storage conditions of pharmaceutical products. This domain standardizes the exchange of stability study designs, conditions, batch testing results, degradation trends, and final conclusions using structured FHIR resources.

How to Build a Stability Bundle

Think of creating a Stability Bundle like a manufacturing line for data. Raw data enters from your source systems, gets fabricated into standardized FHIR resources, wired together with references, packaged into a Bundle, and delivered to downstream consumers. The diagram below shows the full pipeline — then read each station for detailed instructions.

Stability Bundle Pipeline — 5 Station Overview

Station 1

Raw Materials — Gather Source Data

Collect data from your laboratory and quality systems. You need four categories of information:

🧪 LIMS	Test results (assay values, impurity levels, water content), test method references, acceptance criteria limits
📋 QMS	Stability study protocol, time-point schedule (0, 3, 6, 9, 12, 18, 24 months), storage condition assignments
🏢 ERP / MDM	Product master data, batch/lot numbers, substance identity, organization (manufacturer/tester) details
🔬 Lab Notebooks	Specimen handling instructions, storage conditions (25°C/60% RH, 40°C/75% RH), container orientation

Station 2

Resource Fabrication — Create FHIR Resources

Map each category of source data into its corresponding FHIR resource type. Build each resource independently and validate it against its profile before moving on. The stability domain uses the following resource types:

Resource Population Guide

Detailed field-level mapping instructions and FSH examples for all 11 required resource types.

View Fabrication Guide →

Tip: Start with the leaf-level resources (Organization, SpecimenDefinition, ObservationDefinition) and work upward. These have no outbound dependencies.

Station 3

Reference Wiring — Connect Resources Together

Think of this step like plugging cables between electrical sockets — each resource has ports that accept Reference() or canonical links to other resources. Before wiring, your resources are standalone and disconnected. After wiring, they form a connected graph. The key connections are:

From	Link Element	To
DiagnosticReport	`triggeredBy`	PlanDefinition (the study protocol)
DiagnosticReport	`result[]`	Observation (parent results per time-point)
DiagnosticReport	`performer`	Organization (testing laboratory)
PlanDefinition	`action.definitionCanonical`	ActivityDefinition (test activity at each time-point)
ActivityDefinition	`observationRequirement`	ObservationDefinition (test battery X, Y, Z)
Observation (parent)	`hasMember[]`	Observation (individual test results)
Observation	`specimen`, `subject`	Specimen, Medication (batch info)

Station 4

Bundle Assembly — Package the Resources

Assemble all wired resources into a single Bundle of type collection, conforming to the BundleDrugStabilityPq profile. The profile requires at least 12 entries across 13 named slices:

Report (1..*) Protocol (1..1) Test-Set (1..*) Test-Method (1..*) Result-Observations (1..*) Specimen-Definition (1..*) Actual-Batch-Substance (1..*) Actual-Batch-Specimen (1..*) Component-Substance (1..*) Organization (1..*) Product-Identification (0..1) Drug-Ingredient (0..*) Batch-Lot-Information (0..*)

Each entry must include a fullUrl and a resource.

Station 5

Delivery — Ship to Consumers

Your validated Bundle is now ready for downstream consumption. Common delivery targets include:

HTML Showcase	Transform the Bundle JSON/XML into a human-readable stability report with trend charts, protocol matrices, and results tables — see live example.
FHIR R5 API	POST the Bundle to a FHIR server for regulatory submission, cross-study aggregation, or integration with downstream analytical systems.

Drug Product Stability (3.2.P.8)

Resource Architecture

DiagnosticReport	Contains all results as a group and captures overall conclusions.
PlanDefinition	Describes the stability study protocol design and conditions.
ObservationDefinition	Defines individual test methods and acceptance criteria.
Observation	Captures the specific test results at given timepoints.
MedicinalProductDefinition	The drug product (e.g., Stelbat tablets, 20mg).

📈

Interactive Showcase

Experience how computable FHIR quality data can be dynamically rendered into premium, human-readable stability reports with trend visualizations and protocol matrices.

View Product Showcase →

Technical Artifacts

FHIR Bundles

XML Instance JSON Instance

Source Data (CTD PDF)

📄 3.2.P.8.1 Summary & Conclusions 📄 3.2.P.8.3 Stability Data

Drug Substance Stability (3.2.S.7)

Resource Architecture

DiagnosticReport	Contains all results as a group and captures overall conclusions.
SpecificationDefinition	Describes the storage conditions and duration for each test.
ObservationDefinition	Defines individual test methods and acceptance criteria.
Observation	Captures the specific test results at given timepoints.
SubstanceDefinition	The substance being tested.