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. For a full list of available versions, see the Directory of published versions

Table of Contents

.. 0 Table of Contents
... 1 Home Page
... 2 Business Use Cases
... 3 Domains Overview
.... 3.1 Analytical Procedures
..... 3.1.1 Analytical Procedures: synthetic data rendering - drug product
..... 3.1.2 Analytical Procedures: synthetic data rendering - drug substance
.... 3.2 Batch Analysis
..... 3.2.1 Batch Analysis: synthetic data rendering - drug product
..... 3.2.2 Batch Analysis: synthetic data rendering - drug substance
.... 3.3 Batch Formula
..... 3.3.1 Batch Formula: synthetic data rendering - drug product
.... 3.4 Batch/Lot Information
..... 3.4.1 Batch/Lot Information: synthetic data rendering - drug product
..... 3.4.2 Batch/Lot Information: synthetic data rendering - drug substance
.... 3.5 Compatibility
..... 3.5.1 Compatibility: synthetic data rendering - drug product
.... 3.6 Composition
..... 3.6.1 Composition: synthetic data rendering - drug product
..... 3.6.2 Composition: synthetic data rendering - drug substance
.... 3.7 Container Closure System
..... 3.7.1 Container Closure System: synthetic data rendering - drug product
..... 3.7.2 Container Closure System: synthetic data rendering - drug substance
.... 3.8 Drug Specification
..... 3.8.1 Drug Specification: synthetic data rendering - drug product
..... 3.8.2 Drug Specification: synthetic data rendering - drug substance
.... 3.9 Identification
..... 3.9.1 Identification: synthetic data rendering - drug product
..... 3.9.2 Identification: synthetic data rendering - drug product microbiological attributes
..... 3.9.3 Identification: synthetic data rendering - drug product excipients
..... 3.9.4 Identification: synthetic data rendering - drug substance general properties
..... 3.9.5 Identification: synthetic data rendering - drug substance characterisation, elucidation of structure
.... 3.10 Impurities
..... 3.10.1 Impurities: synthetic data rendering - drug product
..... 3.10.2 Impurities: synthetic data rendering - drug substance
.... 3.11 Manufacturing Process
..... 3.11.1 Manufacturing Process: synthetic data rendering - drug product
..... 3.11.2 Manufacturing Process: synthetic data rendering - drug substance
.... 3.12 Organizations
..... 3.12.1 Organizations: synthetic data rendering
.... 3.13 Process Validation
..... 3.13.1 Process Validation: synthetic data rendering - drug product
..... 3.13.2 Process Validation: synthetic data rendering - drug product, biologic
..... 3.13.3 Process Validation: synthetic data rendering - drug substance
.... 3.14 Stability Study
..... 3.14.1 Stability Study: synthetic data rendering - drug product
..... 3.14.2 Stability Study: synthetic data rendering - drug substance
... 4 General Principles & Design
... 5 Downloads
... 6 Artifacts Summary
.... 6.1 Bundle - Analytical Procedure
.... 6.2 Bundle - Batch Analysis
.... 6.3 Bundle - Batch Formula
.... 6.4 Bundle - Product Batch Information
.... 6.5 Bundle - Substance Batch Information
.... 6.6 Bundle - Product Compatibility
.... 6.7 Bundle - Product Composition
.... 6.8 Bundle - Reference Standards
.... 6.9 Bundle - Container Closure System
.... 6.10 Bundle - Product Specification
.... 6.11 Bundle - Substance Specification
.... 6.12 Bundle - Drug Product
.... 6.13 Bundle - Product Microbiological Attributes
.... 6.14 Bundle - Product Excipients
.... 6.15 Bundle - Substance General Properties
.... 6.16 Bundle - Substance Characterization
.... 6.17 Bundle - Impurities
.... 6.18 Bundle - Manufacturing
.... 6.19 Bundle - Organizations
.... 6.20 Bundle - Process Validation
.... 6.21 Bundle - Stability
.... 6.22 Example: Bundle – Analytical Procedure, product
.... 6.23 Example: Bundle – Analytical Procedure, substance
.... 6.24 Example: Bundle – Batch Analysis, product
.... 6.25 Example: Bundle – Batch Analysis, substance
.... 6.26 Example: Bundle - Batch Formula
.... 6.27 Example: Bundle – Product Batch Information
.... 6.28 Example: Bundle – Substance Batch Information
.... 6.29 Example: Bundle – Product Compatibility
.... 6.30 Example: Bundle – Product Composition
.... 6.31 Example: Bundle – Reference Standards, substance
.... 6.32 Example: Bundle - Container Closure System, product
.... 6.33 Example: Bundle - Container Closure System, substance
.... 6.34 Example: Bundle – Product Specification
.... 6.35 Example: Bundle – Substance Specification
.... 6.36 Example: Bundle – Drug Product
.... 6.37 Example: Bundle – Product Microbiological Attributes
.... 6.38 Example: Bundle – Product Excipients
.... 6.39 Example: Bundle – Substance General Properties
.... 6.40 Example: Bundle – Substance Characterization
.... 6.41 Example: Bundle - Impurities, product
.... 6.42 Example: Bundle - Impurities, substance
.... 6.43 Example: Bundle - Manufacturing, product
.... 6.44 Example: Bundle - Manufacturing, substance
.... 6.45 Example: Bundle - Organizations
.... 6.46 Example: Bundle - Process Validation, product
.... 6.47 Example: Bundle - Process Validation, biologic product
.... 6.48 Example: Bundle - Process Validation, substance
.... 6.49 Example: Bundle – Stability, product
.... 6.50 Example: Bundle – Stability, substance
.... 6.51 ActivityDefinition - Test
.... 6.52 Composition - Drug
.... 6.53 DeviceDefinition - Drug
.... 6.54 DiagnosticReport - Drug Analysis
.... 6.55 DocumentReference - Drug
.... 6.56 Ingredient - Drug
.... 6.57 ManufacturedItemDefinition - Drug
.... 6.58 Medication - Batch Information
.... 6.59 MedicinalProductDefinition - Drug Product
.... 6.60 Observation - Test Result
.... 6.61 ObservationDefinition - Test Method
.... 6.62 Organization - Drug
.... 6.63 PackagedProductDefinition - Drug
.... 6.64 PlanDefinition - Drug
.... 6.65 Procedure - Drug
.... 6.66 Specimen - Drug
.... 6.67 SpecimenDefinition - Drug
.... 6.68 Substance - Drug
.... 6.69 SubstanceDefinition - Component Drug
.... 6.70 ActivityDefinition - Test - example 1
.... 6.71 ActivityDefinition - Test - example 2
.... 6.72 Composition - Drug - example, formulation
.... 6.73 Composition - Drug - example, risk
.... 6.74 DeviceDefinition - Drug - example
.... 6.75 DiagnosticReport - Drug Analysis - example, stability
.... 6.76 DocumentReference - Drug - example
.... 6.77 Ingredient - Drug - example
.... 6.78 ManufacturedItemDefinition - Drug - example 1
.... 6.79 ManufacturedItemDefinition - Drug - example 2
.... 6.80 Medication - Batch Information - example
.... 6.81 MedicinalProductDefinition - Drug Product - example
.... 6.82 Observation - Test Result - example 1
.... 6.83 Observation - Test Result - example 2
.... 6.84 ObservationDefinition - Test Method - example 1, longTerm25X
.... 6.85 ObservationDefinition - Test Method - example 2, Water
.... 6.86 Organization - Drug - example 1, manufacturer
.... 6.87 Organization - Drug - example 2, manufacturer
.... 6.88 Organization - Drug - example 3, packaging
.... 6.89 Organization - Drug - example 4, packaging
.... 6.90 Organization - Drug - example 5, testing lab
.... 6.91 PackagedProductDefinition - Drug - example
.... 6.92 PlanDefinition - Drug - example, validation protocol
.... 6.93 PlanDefinition - Drug - example, manufacturing plan
.... 6.94 PlanDefinition - Drug - example, drug specification
.... 6.95 PlanDefinition - Drug - example, manufacturing process
.... 6.96 PlanDefinition - Drug - example, stability study protocol
.... 6.97 Procedure - Drug - example 1
.... 6.98 Procedure - Drug - example 2
.... 6.99 Specimen - Drug - example
.... 6.100 SpecimenDefinition - Drug - example 1
.... 6.101 SpecimenDefinition - Drug - example 2
.... 6.102 SpecimenDefinition - Drug - example 3
.... 6.103 Substance - Drug - example
.... 6.104 SubstanceDefinition - Component Drug - example 1
.... 6.105 SubstanceDefinition - Component Drug - example 2
.... 6.106 SubstanceDefinition - Component Drug - example 3
.... 6.107 accelerated40X
.... 6.108 accelerated40Y
.... 6.109 accelerated40Z
.... 6.110 longTerm25Y
.... 6.111 longTerm25Z
.... 6.112 longTerm30X
.... 6.113 longTerm30Y
.... 6.114 Assay
.... 6.115 Degradation
.... 6.116 Description
.... 6.117 Identification
.... 6.118 Impurities
.... 6.119 Microbiological
.... 6.120 Uniformity
.... 6.121 observation-test-result-longterm25c-initial-1
.... 6.122 observation-test-result-lt25c-i1-degradation-imp2
.... 6.123 observation-test-result-lt25c-i1-degradation-imp3
.... 6.124 observation-test-result-lt25c-i1-degradation-imp-total
.... 6.125 observation-test-result-lt25c-i1-degradation-imp-unspecified
.... 6.126 observation-test-result-lt25c-i1-microbiological
.... 6.127 observation-test-result-lt25c-i1-uniformity
.... 6.128 observation-test-result-lt25c-i1-water
.... 6.129 Extension - Actual Yield
.... 6.130 Extension - Actual Yield Unfiltered
.... 6.131 Extension - Batch Derived From
.... 6.132 Extension - Batch Designation
.... 6.133 Extension - Batch Number of Items
.... 6.134 Extension - Batch Number of Full Shelves
.... 6.135 Extension - Batch Number of Partial Shelves
.... 6.136 Extension - Batch Number of Vials
.... 6.137 Extension - Batch Release Date
.... 6.138 Extension - Batch Retest Date
.... 6.139 Extension - Batch Storage Duration
.... 6.140 Extension - Batch Substance Batch
.... 6.141 Extension - Container Orientation
.... 6.142 Extension - Formulation Number
.... 6.143 Extension - History of Process
.... 6.144 Extension - Impurity Origin
.... 6.145 Extension - Manufacturing Participant
.... 6.146 Extension - Manufacturing Process
.... 6.147 Extension - Medication Definition
.... 6.148 Extension - Novel Excipient
.... 6.149 Extension - Package Definition
.... 6.150 Extension - Packaging Date
.... 6.151 Extension - Packaging Site
.... 6.152 Extension - Plan Document Reference
.... 6.153 Extension - Process Parameters
.... 6.154 Extension - Process Step Scale
.... 6.155 Extension - Qualified Value Criticality
.... 6.156 Extension - Qualified Value Display
.... 6.157 Extension - Qualified Value Target
.... 6.158 Extension - Qualified Value Text
.... 6.159 Extension - Site Utilization
.... 6.160 Extension - Statistical Model
.... 6.161 Extension - Substance Property Parameter
.... 6.162 Extension - Substance Property Range
.... 6.163 Extension - Suitability For Use
.... 6.164 Extension - Target Fill Weight
.... 6.165 Extension - Test Comment
.... 6.166 Extension - Time Point Description
.... 6.167 Batch Designation
.... 6.168 Characterization Steps
.... 6.169 Closure Types
.... 6.170 Colors
.... 6.171 Container Orientations
.... 6.172 ISO Country two letter codes
.... 6.173 Device Properties
.... 6.174 Device Type
.... 6.175 Diagram Types
.... 6.176 Equipment Classes
.... 6.177 Goal Priority
.... 6.178 Grades
.... 6.179 Impurity Origins
.... 6.180 Impurity Types
.... 6.181 Ingredient Function
.... 6.182 Manufactured Item Property
.... 6.183 Manufacturing Participant Role
.... 6.184 Manufacturing Step
.... 6.185 Manufacturing Step Scale
.... 6.186 MedicinalProduct Characteristic Type
.... 6.187 Medicine Dose Form EDQM
.... 6.188 Medicine Route of Administration EDQM
.... 6.189 Package Property
.... 6.190 Pharmaceutical Organization Type
.... 6.191 Plan Type
.... 6.192 Process Validation Procedure
.... 6.193 Process Parameter
.... 6.194 Product Name Type
.... 6.195 Product Site Utilization
.... 6.196 Qualified Value Criticality
.... 6.197 Report Type
.... 6.198 Specification Type
.... 6.199 Substance Property
.... 6.200 Substance Property Value
.... 6.201 Test Method
.... 6.202 Test Category
.... 6.203 Time Point Description
.... 6.204 Batch Designation Codes
.... 6.205 Closure Type Codes
.... 6.206 Container Orientation Codes
.... 6.207 Device Type - example
.... 6.208 Goal Priority - example
.... 6.209 Example Local Codes - Drug
.... 6.210 Manufactured Item Property - example
.... 6.211 Product Name Type - example
.... 6.212 Specification Type - example
.... 6.213 Substance Property - example
.... 6.214 Substance Property Value - example
.... 6.215 Device Property Codes
.... 6.216 Diagram Type Codes
.... 6.217 Drug Substance or Product Color Codes
.... 6.218 Impurity Origin Codes
.... 6.219 Impurity Type Codes
.... 6.220 Ingredient Function Codes
.... 6.221 Manufacturing Participant Role Codes
.... 6.222 Manufacturing Step Scale Codes
.... 6.223 Manufacturing Step Codes
.... 6.224 Observation Qualified Value Criticality Codes
.... 6.225 Package Grade Codes
.... 6.226 Package Property Codes
.... 6.227 Pharmaceutical Manufacturing Equipment Class Codes
.... 6.228 Pharmaceutical Organization Type Codes
.... 6.229 Pharmaceutical Plan Type Codes
.... 6.230 Pharmaceutical Report Type Codes
.... 6.231 Pharmaceutical Test Category Codes
.... 6.232 Process Parameter Codes
.... 6.233 Product Site Utilization Type Codes
.... 6.234 Structure Characterization Technique Codes
.... 6.235 Time Point Description Codes