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

General Principles & Design

đź“‹ How to Use This IG: This implementation guide relies on example files as a priority. Profiles were designed with extra flexibility to facilitate implementation by early adopters. Profiles will be refined and progressively become stricter as implementers gain practical experience with production environments.
đź’ˇ Lessons from ePI: This approach is adopted as a result of implementation experience gained by the Electronic Medicinal Product Information (ePI) FHIR IG project. Early ePI implementers identified greater value in example files than profiles. These lessons are being adapted for the PQ (Industry) project.

Terminology

This IG prioritizes international standards. ISO IDMP is the relevant international standard and designates the European Directorate for the Quality of Medicines and Healthcare (EDQM) for dose form, route of administration, unit of presentation, pack type, and closure type. This IG references EDQM as the preferred terminology for these topics.

This supports data alignment/reuse across pharmaceutical Quality, clinical, ePI, artwork, and defect reporting — and facilitates implementation since most RIM software developers are pre-loading their systems with this terminology for EMA SPOR compliance.

Cross Version Analysis

(None available.)

Dependency Table

IGPackageFHIRComment
.. Pharmaceutical Quality (Industry)hl7.fhir.uv.pharm-quality#1.0.0R5
... HL7 Terminology (THO)hl7.terminology.r5#7.1.0R5Automatically added as a dependency - all IGs depend on HL7 Terminology
.... FHIR Extensions Packhl7.fhir.uv.extensions.r5#5.2.0R5
... FHIR Tooling Extensions IGhl7.fhir.uv.tools.r5#1.1.2R5for example references

Package hl7.fhir.uv.extensions.r5#5.2.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.tools.r5#1.1.2

This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Mar 24, 2026 11:13+1100+11:00)

Global Profiles Table

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.