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

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Home Page

Official URL: http://hl7.org/fhir/uv/pharm-quality/ImplementationGuide/hl7.fhir.uv.pharm-quality Version: 1.0.0
Active as of 2026-05-10 Computable Name: PharmaceuticalQualityIndustry
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41

HL7 FHIR R5 · BR&R Work Group

Pharmaceutical Quality,
structured.

A universal FHIR specification for creating and exchanging structured pharmaceutical quality data internationally — within or between biopharmaceutical companies and their stakeholders.

Get Started

Why the industry is adopting structured PQ data

Move from unstructured PDFs and Word documents to a real-time, structured data model.

⚡
Real-Time Data Exchange

Reduce pharmaceutical data exchange timelines from months to minutes using FHIR APIs. Enable high-frequency, high-volume data flows between sponsors, CMOs, and labs.

♻️
Maximum Data Reuse

Granular, discrete components — like individual tests — can be centrally maintained, version-controlled, and reused across stability studies, specifications, and products.

🤖
AI & Data Science Ready

Highly granular structured data makes pharmaceutical quality information accessible for ontologies, data science, and artificial intelligence applications.

🔗
Any Output Format

FHIR XML or JSON bundles can be transformed into any format required by regulators — PDF, Word, or jurisdiction-specific submission formats.

Scope

✅ In Scope

Products regulated as drugs (small and large molecule medicinal products, including functional and non-functional packaging components; prescription, OTC, and hospital products). Developmental and authorized medicinal products. Data exchange within a biopharmaceutical company, between companies, or between companies and their industry stakeholders.

🔜 Future Phases

Products regulated as devices and veterinary drugs are out of scope for version 1.0.0. New product lines will be brought in scope in future iterations of the implementation guide.

⚠️ Important: This implementation guide is a content exchange standard for industry use. It is not a regulatory submission standard and is not intended for direct submission to National Competent Authorities for medicinal product authorization. Sponsors should reference relevant national regulatory guidance when preparing submission data.

Technical Overview

This implementation guide is based upon FHIR version 5.0.0 and is a Universal Realm Specification. It organizes pharmaceutical quality data into 14 domains designed to maximize structured data use and deliver benefits in flexibility, efficiency, and data reuse.

Audience

🏢
Pharmaceutical Manufacturing

Medicinal product manufacturers managing quality data across global supply chains.

🔬
Contract Labs & CMOs

Contract manufacturing organizations and testing laboratories exchanging structured results.

💻
Technology Vendors

Developers of LIMS, content management, and regulatory information management solutions.

📜
Regulatory Affairs

Business analysts and policy managers involved in biopharmaceutical regulatory affairs.

Strategic Goals

The biopharmaceutical industry is transitioning into its third paradigm of data exchange. This IG accelerates that transition:

Era 1 · Pre-2003
Paper Documents
Printed, published into binders, delivered to health authorities via courier. Manual, effort-intensive processes.
Era 2 · 2003–2023
Electronic Documents
PDFs and Word files submitted via electronic gateways. Increased throughput but still limited by document-centric processes.
Era 3 · Post-2023
Structured Data & APIs
Granular FHIR data delivered via APIs, processed by AI agents. Advanced automation, high throughput.

Figure: Advancement of the Submission and Decision-Making Ecosystems

Considerations for Implementation

The following figure depicts a potential future data pipeline for implementers and the intended scope of this IG relative to the regulatory submission workflow.

Figure: FHIR Data Pipeline for Pharmaceutical Quality (Industry)

STEP I
FHIR data sent to/from partners (e.g., labs, CMOs) via RESTful API.
STEP II
Regulatory systems collate into Resources and Profiles; extract submittable content.
STEP III
Transform FHIR XML/JSON to submission-ready format per national requirements.
STEP IV
Validation against national business rules. (Out of scope)
STEP V
Delivery via accepted exchange method. (Out of scope)

Project Team

Biopharmaceutical Industry
  • Rita Algorri, Amgen Inc.
  • Sheetal Gaiki, Johnson & Johnson
  • Mike Abernathy, Amgen Inc.
  • Craig Anderson, Pfizer Inc.
  • Colin Wood, AstraZeneca
Lantana Consulting Group
  • Rik Smithies
  • Rob Hausam
  • Diana Wright

Acknowledgements

This guide is developed and produced through the efforts of Health Level Seven International (HL7) as part of the Pharmaceutical Quality (Industry) project (Project ID 1800 and Project Scope Statement: PSS-2145).

The project team appreciates the support and sponsorship of the HL7 Public Health Work Group, and all volunteers and staff associated with the creation of this resource. The team appreciates the comments and input from the biopharmaceutical community as well as the HL7 volunteers who participate in the Biomedical Research and Regulation Work Group.

Health Level Seven, HL7, FHIR and the [FLAME DESIGN] are registered trademarks of Health Level Seven International, registered in the US Trademark Office. For acknowledgement of terminology content, please see the IP Statements section.

Providing Feedback

Please suggest improvements and provide notes about issues through HL7's Jira Software (free account and log-in required).

HL7's Confluence pages provide guidance on submitting Specification Feedback in Jira.

See also the HL7 FHIR Community Chat Zulip stream: Pharm Quality Industry IG for discussion about this FHIR IG.