Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Getting Started

Getting Started with Pharmaceutical Quality

Whether you are a Pharmaceutical Sponsor managing quality data, a Contract Lab running analytical tests, or a Technology Vendor building LIMS and RIM solutions — choose your path below.

Choose Your Path

🏢
Pharmaceutical Sponsors

You manage pharmaceutical quality data for drug substances and drug products across global supply chains.

  1. Review the 14 Quality Domains
  2. Study the Business Use Cases
  3. Assess your internal data systems readiness
  4. Engage your LIMS and RIM vendors
🔬
Contract Labs & CMOs

You receive structured quality study protocols and return structured test results via FHIR APIs.

  1. Review Stability Study domain
  2. Understand Batch Analysis workflows
  3. Map your LIMS outputs to FHIR resources
  4. Test with the HL7 Validator
💻
Technology Vendors

You build LIMS, RIM, content management, or structured content authoring platforms.

  1. Study the FHIR Profiles
  2. Review the General Design Principles
  3. Examine domain rendered examples
  4. Validate with the HL7 Validator
The architecture is modular

You don't need to implement all 14 domains at once. Start with the domain most relevant to your business need — such as Stability for shelf-life management, or Batch Analysis for routine quality testing. Each domain's Bundle can be exchanged independently.

Prerequisites

Required
FHIR R5 Server

A FHIR-compliant data repository to store, version, and exchange pharmaceutical quality bundles via RESTful APIs.

Required
Terminology Alignment

Align your internal terminologies with ISO IDMP and EDQM standards for dose form, route of administration, units, and packaging.

Recommended
LIMS / RIM Integration

Connect your Laboratory Information Management System (LIMS) and Regulatory Information Management (RIM) to produce structured FHIR outputs.

Explore Key Domains

Each domain includes a component diagram, resource descriptions, and rendered synthetic data examples.

Validate & Build

Once you have explored the domains and examples:

  1. Validate your bundles — Use the Official FHIR Validator with the PQ IG package to check compliance with the profiles defined in this guide.
  2. Build your own — Use the provided rendered examples as templates. Start with the domain most relevant to your use case.
  3. Connect via API — Exchange bundles between your systems and partners using RESTful FHIR APIs.