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

Table of Contents

.. 0 Table of Contents
... 1 Home Page
... 2 Getting Started
... 3 Business Use Cases
... 4 Domains Overview
.... 4.1 Analytical Procedures
..... 4.1.1 Analytical Procedures: synthetic data rendering - drug product
..... 4.1.2 Analytical Procedures: synthetic data rendering - drug substance
.... 4.2 Batch Analysis
..... 4.2.1 Batch Analysis: synthetic data rendering - drug product
..... 4.2.2 Batch Analysis: synthetic data rendering - drug substance
.... 4.3 Batch Formula
..... 4.3.1 Batch Formula: synthetic data rendering - drug product
.... 4.4 Batch/Lot Information
..... 4.4.1 Batch/Lot Information: synthetic data rendering - drug product
..... 4.4.2 Batch/Lot Information: synthetic data rendering - drug substance
.... 4.5 Compatibility
..... 4.5.1 Compatibility: synthetic data rendering - drug product
.... 4.6 Composition
..... 4.6.1 Composition: synthetic data rendering - drug product
..... 4.6.2 Composition: synthetic data rendering - drug substance
.... 4.7 Container Closure System
..... 4.7.1 Container Closure System: synthetic data rendering - drug product
..... 4.7.2 Container Closure System: synthetic data rendering - drug substance
.... 4.8 Drug Specification
..... 4.8.1 Drug Specification: synthetic data rendering - drug product
..... 4.8.2 Drug Specification: synthetic data rendering - drug substance
.... 4.9 Identification
..... 4.9.1 Identification: synthetic data rendering - drug product
..... 4.9.2 Identification: synthetic data rendering - drug product microbiological attributes
..... 4.9.3 Identification: synthetic data rendering - drug product excipients
..... 4.9.4 Identification: synthetic data rendering - drug substance general properties
..... 4.9.5 Identification: synthetic data rendering - drug substance characterisation, elucidation of structure
.... 4.10 Impurities
..... 4.10.1 Impurities: synthetic data rendering - drug product
..... 4.10.2 Impurities: synthetic data rendering - drug substance
.... 4.11 Manufacturing Process
..... 4.11.1 Manufacturing Process: synthetic data rendering - drug product
..... 4.11.2 Manufacturing Process: synthetic data rendering - drug substance
.... 4.12 Organizations
..... 4.12.1 Organizations: synthetic data rendering
.... 4.13 Process Validation
..... 4.13.1 Process Validation: synthetic data rendering - drug product
..... 4.13.2 Process Validation: synthetic data rendering - drug product, biologic
..... 4.13.3 Process Validation: synthetic data rendering - drug substance
.... 4.14 Stability Study
..... 4.14.1 Resource Fabrication Guide
..... 4.14.2 Stability Study: synthetic data rendering - drug product
..... 4.14.3 Stability Study: synthetic data rendering - drug substance
... 5 General Principles & Design
... 6 Downloads
... 7 Artifacts Summary
.... 7.1 Assay
.... 7.2 Bundle – Analytical Procedure PQ
.... 7.3 Bundle – Drug Product Microbiological Attributes PQ
.... 7.4 bundle-analytical-procedure-pq-ex1
.... 7.5 Description
.... 7.6 Microbiological
.... 7.7 observation-test-result-lt25c-i1-description
.... 7.8 observation-test-result-lt25c-i1-microbiological
.... 7.9 observation-test-result-lt25c-i1-uniformity
.... 7.10 observation-test-result-lt25c-i1-water
.... 7.11 Time Point Description Codes
.... 7.12 Uniformity
.... 7.13 Water
.... 7.14 Bundle – Batch Analysis PQ
.... 7.15 bundle-batch-analysis-pq-ex1
.... 7.16 Bundle – Batch Formula PQ
.... 7.17 bundle-batch-formula-pq-ex1
.... 7.18 Bundle – drug Product Batch Information PQ
.... 7.19 Bundle – Drug Substance Batch Information PQ
.... 7.20 bundle-drug-product-batch-info-pq-ex1
.... 7.21 Medication - Batch Information Drug PQ
.... 7.22 medication-batch-information-drug-pq-ex1
.... 7.23 Bundle - Drug Product Compatibility PQ
.... 7.24 bundle-drug-product-compatibility-pq-ex1
.... 7.25 3.2.P.2.2.1 - Formulation Development
.... 7.26 3.2.P.2.2.4 - Summary for Risk of Impurities
.... 7.27 Bundle – Drug Product Composition PQ
.... 7.28 Bundle – Drug Substance Characterization PQ
.... 7.29 Bundle – Drug Substance General Properties PQ
.... 7.30 Bundle – Drug Substance Specification PQ
.... 7.31 bundle-drug-product-composition-pq-ex1
.... 7.32 Composition - Drug PQ
.... 7.33 Ingredient - Drug Pq
.... 7.34 ingredient-drug-pq-ex1
.... 7.35 medicinalproductdefinition-drug-product-pq-ex1
.... 7.36 packagedproductdefinition-drug-pq-ex1
.... 7.37 Substance - Drug PQ
.... 7.38 substance-drug-pq-ex1
.... 7.39 SubstanceDefinition - Component Substance Drug PQ
.... 7.40 substancedefinition-component-substance-drug-pq-ex1
.... 7.41 Bundle – Container Closure System PQ
.... 7.42 bundle-container-closure-system-pq-ex1
.... 7.43 PackagedProductDefinition - Drug PQ
.... 7.44 Bundle – Drug Product Specification PQ
.... 7.45 bundle-drug-product-specification-pq-ex1
.... 7.46 SPECIFICATION(S) FOR DRUG PRODUCT
.... 7.47 Identification
.... 7.48 Bundle - Product Impurities PQ
.... 7.49 bundle-product-impurities-pq-ex1
.... 7.50 Degradation
.... 7.51 Impurities
.... 7.52 observation-test-result-lt25c-i1-degradation-imp-total
.... 7.53 observation-test-result-lt25c-i1-degradation-imp-unspecified
.... 7.54 observation-test-result-lt25c-i1-degradation-imp1
.... 7.55 observation-test-result-lt25c-i1-degradation-imp2
.... 7.56 observation-test-result-lt25c-i1-degradation-imp3
.... 7.57 Bundle - Product Manufacturing PQ
.... 7.58 Bundle - Product Process Validation PQ
.... 7.59 bundle-product-manufacturing-pq-ex1
.... 7.60 documentreference-drug-pq-process-flow-diagram
.... 7.61 Procedure - Drug PQ
.... 7.62 procedure-drug-pq-ex1
.... 7.63 procedure-drug-pq-ex2
.... 7.64 Process 1.0
.... 7.65 Process 1.0
.... 7.66 Bundle - Organizations PQ
.... 7.67 bundle-organizations-pq-ex1
.... 7.68 Organization - Drug PQ
.... 7.69 organization-drug-pq-ex1
.... 7.70 organization-drug-pq-ex2
.... 7.71 organization-drug-pq-ex3
.... 7.72 organization-drug-pq-ex4
.... 7.73 organization-drug-pq-ex5
.... 7.74 bundle-product-process-validation-pq-ex1
.... 7.75 DP PROCESS VALIDATION
.... 7.76 Bundle – Drug Stability PQ
.... 7.77 Example: Bundle – Stability, product
.... 7.78 Example: Bundle – Stability, substance
.... 7.79 Extension - Actual Yield PQ
.... 7.80 Extension - Formulation Number PQ
.... 7.81 Extension - Packaging Date PQ
.... 7.82 Extension - Plan Document Reference PQ
.... 7.83 Extension - Qualified Value Criticality PQ
.... 7.84 accelerated40X
.... 7.85 accelerated40Y
.... 7.86 accelerated40Z
.... 7.87 ActivityDefinition - Test Drug PQ
.... 7.88 Bundle - Drug Product PQ
.... 7.89 Bundle – Drug Product Excipients PQ
.... 7.90 Bundle – Drug Reference Standards PQ
.... 7.91 DeviceDefinition - Drug PQ
.... 7.92 devicedefinition-drug-pq-ex1
.... 7.93 DiagnosticReport - Analysis Drug PQ
.... 7.94 diagnosticreport-analysis-drug-pq-stability-prod
.... 7.95 DocumentReference - Drug PQ
.... 7.96 Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
.... 7.97 longTerm25X
.... 7.98 longTerm25Y
.... 7.99 longTerm25Z
.... 7.100 longTerm30X
.... 7.101 longTerm30Y
.... 7.102 Lyophilization
.... 7.103 ManufacturedItemDefinition - Drug PQ
.... 7.104 MedicinalProductDefinition - Drug Product PQ
.... 7.105 Observation - Test Result Drug PQ
.... 7.106 observation-test-result-longterm25c-initial-1
.... 7.107 ObservationDefinition - Test Method PQ
.... 7.108 PlanDefinition - Drug PQ
.... 7.109 Specimen - Drug PQ
.... 7.110 specimen-drug-pq-ex1
.... 7.111 SpecimenDefinition - Drug PQ
.... 7.112 specimendefinition-drug-pq-ex1
.... 7.113 specimenDefStoredAt30
.... 7.114 specimenDefStoredAt40
.... 7.115 Stability Monitoring Program
.... 7.116 Test Category
.... 7.117 Extension - Actual Yield Unfiltered PQ
.... 7.118 Extension - Batch Derived From PQ
.... 7.119 Extension - Batch Designation PQ
.... 7.120 Extension - Batch Number of Full Shelves PQ
.... 7.121 Extension - Batch Number of Items PQ
.... 7.122 Extension - Batch Number of Partial Shelves PQ
.... 7.123 Extension - Batch Number of Vials PQ
.... 7.124 Extension - Batch Release Date PQ
.... 7.125 Extension - Batch Retest Date PQ
.... 7.126 Extension - Batch Storage Duration PQ
.... 7.127 Extension - Batch Substance Batch PQ
.... 7.128 Extension - Container Orientation PQ
.... 7.129 Extension - History of Process PQ
.... 7.130 Extension - Impurity Origin PQ
.... 7.131 Extension - Manufacturing Participant PQ
.... 7.132 Extension - Manufacturing Process PQ
.... 7.133 Extension - Medication Definition PQ
.... 7.134 Extension - Novel Excipient PQ
.... 7.135 Extension - Package Definition PQ
.... 7.136 Extension - Packaging Site PQ
.... 7.137 Extension - Process Parameters PQ
.... 7.138 Extension - Process Step Scale PQ
.... 7.139 Extension - Qualified Value Display PQ
.... 7.140 Extension - Qualified Value Target PQ
.... 7.141 Extension - Qualified Value Text PQ
.... 7.142 Extension - Site Utilization PQ
.... 7.143 Extension - Statistical Model PQ
.... 7.144 Extension - Substance Property Parameter PQ
.... 7.145 Extension - Substance Property Range PQ
.... 7.146 Extension - Suitability for Use PQ
.... 7.147 Extension - Test Comment PQ
.... 7.148 Extension - Time Point Description PQ
.... 7.149 Extension Target Fill Weight PQ
.... 7.150 Batch Designation
.... 7.151 Characterization Steps
.... 7.152 Closure Types
.... 7.153 Colors
.... 7.154 Container Orientations
.... 7.155 Device Properties
.... 7.156 Device Type
.... 7.157 Diagram Types
.... 7.158 Equipment Classes
.... 7.159 Goal Priority
.... 7.160 Grades
.... 7.161 Impurity Origins
.... 7.162 Impurity Types
.... 7.163 Ingredient Function
.... 7.164 ISO Country two letter codes
.... 7.165 Manufactured Item Property
.... 7.166 Manufacturing Participant Role
.... 7.167 Manufacturing Step
.... 7.168 Manufacturing Step Scale
.... 7.169 MedicinalProduct Characteristic Type
.... 7.170 Medicine Dose Form EDQM
.... 7.171 Medicine Route of Administration EDQM
.... 7.172 Package Property
.... 7.173 Pharmaceutical Organization Type
.... 7.174 Plan Type
.... 7.175 Process Parameter
.... 7.176 Process Validation Procedure
.... 7.177 Product Name Type
.... 7.178 Product Site Utilization
.... 7.179 Qualified Value Criticality
.... 7.180 Report Type
.... 7.181 Specification Type
.... 7.182 Substance Property
.... 7.183 Substance Property Value
.... 7.184 Test Method
.... 7.185 Time Point Description
.... 7.186 Batch Designation Codes
.... 7.187 Closure Type Codes
.... 7.188 Container Orientation Codes
.... 7.189 Device Property Codes
.... 7.190 Device Type - example
.... 7.191 Diagram Type Codes
.... 7.192 Drug Substance or Product Color Codes
.... 7.193 Example Local Codes - Drug
.... 7.194 Goal Priority - example
.... 7.195 Impurity Origin Codes
.... 7.196 Impurity Type Codes
.... 7.197 Ingredient Function Codes
.... 7.198 Manufactured Item Property - example
.... 7.199 Manufacturing Participant Role Codes
.... 7.200 Manufacturing Step Codes
.... 7.201 Manufacturing Step Scale Codes
.... 7.202 Observation Qualified Value Criticality Codes
.... 7.203 Package Grade Codes
.... 7.204 Package Property Codes
.... 7.205 Pharmaceutical Manufacturing Equipment Class Codes
.... 7.206 Pharmaceutical Organization Type Codes
.... 7.207 Pharmaceutical Plan Type Codes
.... 7.208 Pharmaceutical Report Type Codes
.... 7.209 Pharmaceutical Test Category Codes
.... 7.210 Process Parameter Codes
.... 7.211 Product Name Type - example
.... 7.212 Product Site Utilization Type Codes
.... 7.213 Specification Type - example
.... 7.214 Structure Characterization Technique Codes
.... 7.215 Substance Property - example
.... 7.216 Substance Property Value - example