Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. The current version which supersedes this version is 1.0.0. 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 Identification
.... 3.2 Identification: CMC synthetic data rendering - drug product
.... 3.3 Identification: CMC synthetic data rendering - drug product
.... 3.4 Identification: CMC synthetic data rendering - drug product
.... 3.5 Identification: CMC synthetic data rendering - drug substance
.... 3.6 Identification: CMC synthetic data rendering - drug substance
.... 3.7 Composition
.... 3.8 Composition: CMC synthetic data rendering - drug product
.... 3.9 Composition: CMC synthetic data rendering - drug substance
.... 3.10 Impurities
.... 3.11 Impurities: CMC synthetic data rendering - drug product
..... 3.11.1 Impurities: CMC synthetic data rendering - drug substance
.... 3.12 Organizations
.... 3.13 Organizations: CMC synthetic data rendering
.... 3.14 Batch/Lot Information
.... 3.15 Batch/Lot Information: CMC synthetic data rendering - drug product
.... 3.16 Batch/Lot Information: CMC synthetic data rendering - drug substance
.... 3.17 Batch Analysis
.... 3.18 Batch Analysis: CMC synthetic data rendering - drug product
.... 3.19 Batch Analysis: CMC synthetic data rendering - drug substance
.... 3.20 Batch Formula
.... 3.21 Batch Formula: CMC synthetic data rendering - drug product
.... 3.22 Manufacturing Process
.... 3.23 Manufacturing Process: CMC synthetic data rendering - drug product
.... 3.24 Manufacturing Process: CMC synthetic data rendering - drug substance
.... 3.25 Process Validation
.... 3.26 Process Validation: CMC synthetic data rendering - drug product
.... 3.27 Process Validation: CMC synthetic data rendering - drug product, biologic
.... 3.28 Process Validation: CMC synthetic data rendering - drug substance
.... 3.29 Analytical Procedures
.... 3.30 Analytical Procedures: CMC synthetic data rendering - drug product
.... 3.31 Analytical Procedures: CMC synthetic data rendering - drug substance
.... 3.32 Container Closure System
.... 3.33 Container Closure System: CMC synthetic data rendering - drug product
.... 3.34 Container Closure System: CMC synthetic data rendering - drug substance
.... 3.35 Stability Study
.... 3.36 Stability Study: CMC synthetic data rendering - drug product
.... 3.37 Stability Study: CMC synthetic data rendering - drug substance
.... 3.38 Drug Specification
.... 3.39 Drug Specification: CMC synthetic data rendering - drug product
.... 3.40 Drug Specification: CMC synthetic data rendering - drug substance
.... 3.41 Compatibility
.... 3.42 Compatibility: CMC synthetic data rendering - drug product
... 4 Best Practices, Resources
... 5 Downloads
... 6 Artifacts Summary
.... 6.1 Profile: Bundle - Analytical Procedure
.... 6.2 Example: Bundle – Analytical Procedure, product
.... 6.3 Example: Bundle – Analytical Procedure, substance
.... 6.4 Profile: Bundle - Batch Analysis
.... 6.5 Example: Bundle – Batch Analysis, product
.... 6.6 Example: Bundle – Batch Analysis, substance
.... 6.7 Profile: Bundle - Batch Formula
.... 6.8 Example: Bundle - Batch Formula
.... 6.9 Profile: Bundle - Product Batch Information
.... 6.10 Profile: Bundle - Substance Batch Information
.... 6.11 Example: Bundle – Product Batch Information
.... 6.12 Example: Bundle – Substance Batch Information
.... 6.13 Profile: Bundle - Product Compatibility
.... 6.14 Example: Bundle – Product Compatibility
.... 6.15 Profile: Bundle - Product Composition
.... 6.16 Profile: Bundle - Reference Standards
.... 6.17 Example: Bundle – Product Composition
.... 6.18 Example: Bundle – Reference Standards, substance
.... 6.19 Profile: Bundle - Container Closure System
.... 6.20 Example: Bundle - Container Closure System, product
.... 6.21 Example: Bundle - Container Closure System, substance
.... 6.22 Profile: Bundle - Product Specification
.... 6.23 Profile: Bundle - Substance Specification
.... 6.24 Example: Bundle – Product Specification
.... 6.25 Example: Bundle – Substance Specification
.... 6.26 Profile: Bundle - Drug Product
.... 6.27 Profile: Bundle - Product Microbiological Attributes
.... 6.28 Profile: Bundle - Product Excipients
.... 6.29 Profile: Bundle - Substance General Properties
.... 6.30 Profile: Bundle - Substance Characterization
.... 6.31 Example: Bundle – Drug Product
.... 6.32 Example: Bundle – Product Microbiological Attributes
.... 6.33 Example: Bundle – Product Excipients
.... 6.34 Example: Bundle – Substance General Properties
.... 6.35 Example: Bundle – Substance Characterization
.... 6.36 Profile: Bundle - Impurities
.... 6.37 Example: Bundle - Impurities, product
.... 6.38 Example: Bundle - Impurities, substance
.... 6.39 Profile: Bundle - Manufacturing
.... 6.40 Example: Bundle - Manufacturing, product
.... 6.41 Example: Bundle - Manufacturing, substance
.... 6.42 Profile: Bundle - Organizations
.... 6.43 Example: Bundle - Organizations
.... 6.44 Profile: Bundle - Process Validation
.... 6.45 Example: Bundle - Process Validation, product
.... 6.46 Example: Bundle - Process Validation, biologic product
.... 6.47 Example: Bundle - Process Validation, substance
.... 6.48 Profile: Bundle - Stability
.... 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
.... 6.87 PackagedProductDefinition - Drug - example
.... 6.88 PlanDefinition - Drug - example, validation protocol
.... 6.89 PlanDefinition - Drug - example, manufacturing plan
.... 6.90 PlanDefinition - Drug - example, drug specification
.... 6.91 PlanDefinition - Drug - example, manufacturing process
.... 6.92 PlanDefinition - Drug - example, stability study protocol
.... 6.93 Procedure - Drug - example 1
.... 6.94 Procedure - Drug - example 2
.... 6.95 Specimen - Drug - example
.... 6.96 SpecimenDefinition - Drug - example 1
.... 6.97 SpecimenDefinition - Drug - example 2
.... 6.98 SpecimenDefinition - Drug - example 3
.... 6.99 Substance - Drug - example
.... 6.100 SubstanceDefinition - Component Drug - example 1
.... 6.101 SubstanceDefinition - Component Drug - example 2
.... 6.102 SubstanceDefinition - Component Drug - example 3
.... 6.103 Extension - Actual Yield
.... 6.104 Extension - Actual Yield Unfiltered
.... 6.105 Extension - Batch Derived From
.... 6.106 Extension - Batch Designation
.... 6.107 Extension - Batch Number of Full Shelves
.... 6.108 Extension - Batch Number of Partial Shelves
.... 6.109 Extension - Batch Number of Vials
.... 6.110 Extension - Batch Release Date
.... 6.111 Extension - Batch Retest Date
.... 6.112 Extension - Batch Storage Duration
.... 6.113 Extension - Batch Substance Batch
.... 6.114 Extension - Container Orientation
.... 6.115 Extension - Formulation Number
.... 6.116 Extension - History of Process
.... 6.117 Extension - Impurity Origin
.... 6.118 Extension - Manufacturing Participant
.... 6.119 Extension - Manufacturing Process
.... 6.120 Extension - Medication Definition
.... 6.121 Extension - Novel Excipient
.... 6.122 Extension - Package Definition
.... 6.123 Extension - Packaging Date
.... 6.124 Extension - Packaging Site
.... 6.125 Extension - Plan Document Reference
.... 6.126 Extension - Process Parameters
.... 6.127 Extension - Process Step Scale
.... 6.128 Extension - Qualified Value Criticality
.... 6.129 Extension - Qualified Value Display
.... 6.130 Extension - Qualified Value Target
.... 6.131 Extension - Qualified Value Text
.... 6.132 Extension - Site Utilization
.... 6.133 Extension - Statistical Model
.... 6.134 Extension - Substance Property Parameter
.... 6.135 Extension - Substance Property Range
.... 6.136 Extension - Suitability For Use
.... 6.137 Extension - Target Fill Weight
.... 6.138 Extension - Test Comment
.... 6.139 Extension - Time Point Description
.... 6.140 accelerated40X
.... 6.141 accelerated40Y
.... 6.142 accelerated40Z
.... 6.143 longTerm25Y
.... 6.144 longTerm25Z
.... 6.145 longTerm30X
.... 6.146 longTerm30Y
.... 6.147 Assay
.... 6.148 Degradation
.... 6.149 Description
.... 6.150 Identification
.... 6.151 Impurities
.... 6.152 Microbiological
.... 6.153 Uniformity
.... 6.154 observation-test-result-longterm25c-initial-1
.... 6.155 observation-test-result-lt25c-i1-degradation-imp2
.... 6.156 observation-test-result-lt25c-i1-degradation-imp3
.... 6.157 observation-test-result-lt25c-i1-degradation-imp-total
.... 6.158 observation-test-result-lt25c-i1-degradation-imp-unspecified
.... 6.159 observation-test-result-lt25c-i1-microbiological
.... 6.160 observation-test-result-lt25c-i1-uniformity
.... 6.161 observation-test-result-lt25c-i1-water
.... 6.162 Closure Type Terminology
.... 6.163 MedicinalProduct Characteristic Type
.... 6.164 Medicine Dose Form EDQM
.... 6.165 Medicine Route of Administration EDQM
.... 6.166 ValueSet - Batch Designation
.... 6.167 ValueSet - Container Orientation
.... 6.168 ValueSet - Device Property
.... 6.169 ValueSet - Device Type
.... 6.170 ValueSet - Impurity Origin
.... 6.171 ValueSet - Ingredient Function
.... 6.172 ValueSet - Manufactured Item Property
.... 6.173 ValueSet - Manufacturing Step
.... 6.174 ValueSet - Manufacturing Step Scale
.... 6.175 ValueSet - Package Property
.... 6.176 ValueSet - Plan Type
.... 6.177 ValueSet - Process Validation Procedure
.... 6.178 ValueSet - Product Site Utilization
.... 6.179 ValueSet - Qualified Value Criticality
.... 6.180 ValueSet - Test Method
.... 6.181 ValueSet - Time Point Description
.... 6.182 CodeSystem - Batch Designation
.... 6.183 CodeSystem - Characterization Step
.... 6.184 CodeSystem - Closure Types
.... 6.185 CodeSystem - Color
.... 6.186 CodeSystem - Container Orientation
.... 6.187 CodeSystem - Control Criticality
.... 6.188 CodeSystem - Device Property
.... 6.189 CodeSystem - Device Type
.... 6.190 CodeSystem - Diagram Type
.... 6.191 CodeSystem - Equipment Class
.... 6.192 CodeSystem - Goal Priority
.... 6.193 CodeSystem - Grade
.... 6.194 CodeSystem - ICH M7 Classification
.... 6.195 CodeSystem - Impurity Origin
.... 6.196 CodeSystem - Impurity Type
.... 6.197 CodeSystem - Ingredient Function
.... 6.198 CodeSystem - Example Local Codes - Drug
.... 6.199 CodeSystem - Manufactured Item Property
.... 6.200 CodeSystem - Manufacturing Participant Role
.... 6.201 CodeSystem - Manufacturing Step
.... 6.202 CodeSystem - Manufacturing Step Scale
.... 6.203 CodeSystem - Mutagenicity
.... 6.204 CodeSystem - Mutagenicity Classification Type
.... 6.205 CodeSystem - Package Property
.... 6.206 CodeSystem - Plan Type
.... 6.207 CodeSystem - Process Parameter
.... 6.208 CodeSystem - Product Name Type
.... 6.209 CodeSystem - Product Site Utilization Type
.... 6.210 CodeSystem - Qualified Value Criticality
.... 6.211 CodeSystem - Report Type
.... 6.212 CodeSystem - Specification Type
.... 6.213 CodeSystem - Substance Property
.... 6.214 CodeSystem - Substance Property Solubility
.... 6.215 CodeSystem - Substance Property Type
.... 6.216 CodeSystem - Test Category
.... 6.217 CodeSystem - Time Point Description