Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

General Principles & Design

How to Use This IG

This implementation guide is designed to rely on example files as a priority. Profiles were designed with an extra degree of flexibility to facilitate implementation by early adopters. Profiles will be refined and progressively become stricter as implementers gain practical experience with production environments.

This approach is being adopted as a result of implementation experience gained to date by the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide project. Early experience by ePI implementers identified a greater value and dependence on ePI example files rather than the profiles. As a result, the ePI IG is being updated to relax profile constraints and significantly increase the number and variety of example files to facilitate implementation.

These lessons learned from the ePI project are being adapted for the Pharmaceutical Quality (Industry) project to facilitate implementation.

Terminology

This IG prioritizes international standards where they exist. In this case, International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) is the relevant international standard. It has designated the European Directorate for the Quality of Medicines and Healthcare (EDQM) as the standard for dose form, route of administration, unit of presentation, pack type, closure type. Therefore, to maintain alignment with IDMP, this IG will reference EDQM as the preferred terminology for the aforementioned topics.

This has the added benefit of supporting industry’s intended use case for data alignment/reuse across pharmaceutical Quality , clinical, ePI, artwork, and defect reporting to name a few. This also facilitates industry’s implementation since most regulatory information management (RIM) software developers are already pre-loading their systems with this terminology to facilitate compliance with the EMA’s IDMP implementation through their substances, products, organisations and referentials (SPOR) program.

Cross Version Analysis

(None available.)

Dependency Table

IGPackageFHIRComment
.. Pharmaceutical Quality (Industry)hl7.fhir.uv.pharm-quality#1.0.0R5
... FHIR Extensions Packhl7.fhir.uv.extensions.r5#5.1.0R5Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
... HL7 Terminology (THO)hl7.terminology.r5#5.0.0R5Automatically added as a dependency - all IGs depend on HL7 Terminology

Package hl7.fhir.uv.extensions.r5#5.1.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sat, Apr 27, 2024 18:39+1000+10:00)

Global Profiles Table

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.