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

Domains Overview

The Quality sections of regulatory applications are organized into a table of contents that includes sections and sub-sections under the titles “Drug Substance” and “Drug Product”. The structure is defined in the ICH Common Technical Document for the Registration of Pharmaceuticals for Human Use. This Common Technical Document (CTD) structure is designed for unstructured PDF and Word documents.

📋 Rather than recreating the legacy ICH CTD table of contents in FHIR, pharmaceutical quality data are organized into 14 new domains designed to maximize structured data use and deliver benefits in flexibility, efficiency, and data reuse. New here? Start with the Getting Started guide →

Browse All 14 Domains

1. Identification
Drug product & substance identification, properties, excipients
2. Composition
Product description, formulation, reference standards
3. Impurities
Characterisation of product & substance impurities
4. Organizations
Manufacturers, testing labs, packaging sites
5. Batch/Lot Info
Batch details for products and substances
6. Batch Analysis
Structured test results per batch
7. Batch Formula
Manufacturing batch formulation details
8. Manufacturing
Process description, controls, critical steps
9. Process Validation
Validation protocols, results, evaluation
10. Analytical Procedures
Test methods and analytical techniques
11. Container Closure
Packaging components and closure systems
12. Stability Study
Protocols, conditions, test results, conclusions
13. Drug Specification
Test specifications and acceptance criteria
14. Compatibility
Drug product pharmaceutical development compatibility

Figure: Pharmaceutical Quality FHIR IG Data Domains

The 14 pharmaceutical Quality (PQ) domains and their supporting sub-domains. Each domain is based on a major Quality concept. Click on any section in the figure below to navigate to its detail page.

Table: Mapping the legacy ICH CTD Drug Substance and Drug Product sections to the new FHIR Quality Domains

FHIR IG Domain Drug Product Drug Substance
1. Identification 3.2.P.2 Pharmaceutical Development
   3.2.P.2.2 Drug Product
   3.2.P.2.5 Microbiological Attributes
3.2.P.4 Control of Excipients
   3.2.P.4.5 Excipients of Human or Animal Origin
   3.2.P.4.6 Novel Excipients		 3.2.S.1 General Information
   3.2.S.1.3 General Properties
3.2.S.3 Characterisation
   3.2.S.3.1 Elucidation of Structure and Other Characteristics
2. Composition 3.2.P.1 Description and Composition of the Drug Product
   3.2.P.6 Reference Standards or Materials		 3.2.S.5 Reference Standards or Materials
3. Impurities 3.2.P.5 Control of Drug Product
   3.2.P.5.5 Characterisation of Impurities		 3.2.S.3 Characterisation
   3.2.S.3.2 Impurities
4. Organizations 3.2.P.3 Manufacture
   3.2.P.3.1 Manufacturer(s)		 3.2.S.2 Manufacture
   3.2.S.2.1 Manufacturer(s)
5. Batch or Lot Information 3.2.P.5 Control of Drug Product
   3.2.P.5.4 Batch Analyses		 3.2.S.4 Control of Drug Substance
   3.2.S.4.4 Batch Analyses
6. Batch Analysis 3.2.P.5 Control of Drug Product
   3.2.P.5.4 Batch Analyses		 3.2.S.4 Control of Drug Substance
   3.2.S.4.4 Batch Analyses
7. Batch Formula 3.2.P.3 Manufacture
   3.2.P.3.2 Batch Formula		 Not Applicable
8. Manufacturing Process 3.2.P.3 Manufacture
   3.2.P.3.3 Description of Manufacturing Process and Process Controls
   3.2.P.3.4 Controls of Critical Steps and Intermediates		 3.2.S.2 Manufacture
   3.2.S.2.2 Description of Manufacturing Process and Process Controls
9. Process Validation 3.2.P.3 Manufacture
   3.2.P.3.5 Process Validation and/or Evaluation		 3.2.S.2 Manufacture
   3.2.S.2.5 Process Validation and/or Evaluation
10. Analytical Procedures 3.2.P.5 Control of Drug Product
   3.2.P.5.2 Analytical Procedures		 3.2.S.4 Control of Drug Substance
   3.2.S.4.2 Analytical Procedures
11. Container Closure System 3.2.P.2 Pharmaceutical Development
   3.2.P.2.4 Container Closure System
3.2.P.7 Container Closure System		 3.2.S.6 Container Closure System
12. Stability Study 3.2.P.8 Stability
   3.2.P.8.1 Stability Summary and Conclusions
   3.2.P.8.3 Stability Data		 3.2.S.7 Stability
   3.2.S.7.1 Stability Summary and Conclusions
   3.2.S.7.3 Stability Data
13. Drug Specifications 3.2.P.5 Control of Drug Product
   3.2.P.5.1 Specification(s)		 3.2.S.4 Control of Drug Substance
   3.2.S.4.1 Specification
14. Compatibility 3.2.P.2 Pharmaceutical Development
   3.2.P.2.6 Compatibility		 Not Applicable

Matrix: Reuse of FHIR Component Building Blocks Across Pharmaceutical Quality Domains

Pharmaceutical Quality (Industry) FHIR IG component profiles 1. Drug Identification 2. Composition 3. Impurities 4. Organizations 5. Batch/Lot Information 6. Batch Analysis 7. Batch Formula 8. Manufacturing Process 9. Process Validation 10. Analytical Procedures 11. Container Closure System 12. Stability Study 13. Drug Specification 14. Compatibility
ActivityDefinition - Test    X    X
Composition - Drug    X
DeviceDefinition - Drug    X    X    X
DiagnosticReport - Drug Analysis    X    X    X    X    X    X    X
DocumentReference - Drug    X    X
Ingredient - Drug    X    X    X    X    X    X    X    X    X
ManufacturedItemDefinition - Drug    X    X
Medication - Batch Information    X    X    X    X    X    X    X    X
MedicinalProductDefinition - Drug Product    X    X    X    X    X    X    X    X    X    X    X    X    X
Observation - Test Result    X    X    X    X    X    X    X
ObservationDefinition - Test Method    X    X    X    X    X    X    X    X    X
Organization - Drug    X    X    X    X    X    X    X    X    X    X    X
PackagedProductDefinition - Drug    X    X
PlanDefinition - Drug    X    X    X    X    X    X    X    X    X    X
Procedure - Drug    X
Specimen - Drug    X    X
SpecimenDefinition - Drug    X    X
Substance - Drug    X    X    X    X    X
SubstanceDefinition - Component Drug    X    X    X    X    X    X    X    X    X    X    X    X
Identification Composition Impurities Organization Batch / Lot Information Batch Analysis Manufacturing Batch Formula Process Validation Analytical Procedures Container Closure System Stability Study Specification Compatibility

Summary of Domain Resources

The resources that are used across all domains are summarized in this diagram: