Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

## Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

### Domain Bundle Profiles

This page provides a list of the FHIR artifacts defined as part of this implementation guide. Note that the mention of CTD sections, and the use of CTD style templates in the examples, are provided as points of reference for implementers and are to facilitate implementer ability to map the new 14 domain/subdomain granular structure to traditional CTD style templates. That mapping is also meant to facilitate the design of transformers for converting from the default FHIR XML or JSON format to the relevant format needed to comply with the requirements stipulated by national competent authority responsible for authorizing medicinal products. As noted in section 1.2 scope, sponsors are expected to reference and adhere to the relevant national regulatory guidance when preparing data for a regulatory application.

Bundle - Analytical Procedure | Analytical Procedure domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.2 Analytical Procedures and section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.2 Analytical Procedures.
Bundle - Batch Analysis | Batch Analysis domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses and CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.
Bundle - Batch Formula | Batch Formula domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.2 Batch Formula.
Bundle - Product Batch Information | Batch/Lot Information domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses.
Bundle - Substance Batch Information | Batch/Lot Information domain: This Bundle profile represents the structured data used in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.
Bundle - Product Compatibility | Compatibility domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.6 Compatibility.
Bundle - Product Composition | Composition domain: This Bundle profile represents the structured data used in CTD section 3.2.P.1 Description and Composition of the Drug Product.
Bundle - Reference Standards | Composition domain: This Bundle profile represents the structured data in CTD sections 3.2.P.6 Reference Standards or Materials and 3.2.S.5 Reference Standards or Materials.
Bundle - Container Closure System | Container Closure System domain: This Bundle profile represents the structured data in CTD sections 3.2.P.7 Container Closure System and 3.2.S.6 Container Closure System.
Bundle - Product Specification | Specification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.1 Specification(s).
Bundle - Substance Specification | Specification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification.
Bundle - Drug Product | Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.2 Drug Product.
Bundle - Product Microbiological Attributes | Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.5 Microbiological Attributes.
Bundle - Product Excipients | Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.4 Control of Excipients, subsections 3.2.P.4.5 Excipients of Human or Animal Origin and 3.2.P.4.6 Novel Excipients.
Bundle - Substance General Properties | Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.1 General Information, subsection 3.2.S.1.3 General Properties.
Bundle - Substance Characterization | Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.1 – Elucidation of Structure and Other Characteristics.
Bundle - Impurities | Impurities domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.5 Characterisation of Impurities and CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.2 Impurities.
Bundle - Manufacturing | Manufacturing Process domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.2 Description of Manufacturing Process and Process Controls.
Bundle - Organizations | Organizations domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.1 Manufacturer(s) and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.1 Manufacturer(s).
Bundle - Process Validation | Process Validation domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.5 Process Validation and/or Evaluation and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.5 Process Validation and/or Evaluation.
Bundle - Stability | Stability Study domain: This Bundle profile represents the structured data used in CTD section 3.2.P.8 Stability, subsection 3.2.P.8.3 Stability Data, and CTD section 3.2.S.7 Stability, subsection 3.2.S.7.3 Stability Data.

### Domain Bundle Examples

Example: Bundle – Analytical Procedure, product | Example of Bundle – Analytical Procedure for drug product.
Example: Bundle – Analytical Procedure, substance | Example of Bundle – Analytical Procedure for drug substance.
Example: Bundle – Batch Analysis, product | Example of Bundle – Batch Analysis for drug product.
Example: Bundle – Batch Analysis, substance | Example of Bundle – Batch Analysis for drug substance.
Example: Bundle - Batch Formula | Example of Bundle - Batch Formula for drug product.
Example: Bundle – Product Batch Information | Example of Bundle – Product Batch Information.
Example: Bundle – Substance Batch Information | Example of Bundle – Substance Batch Information.
Example: Bundle – Product Compatibility | Example of Bundle – Product Compatibility.
Example: Bundle – Product Composition | Example of Bundle – Product Composition.
Example: Bundle – Reference Standards, substance | Example of Bundle – Reference Standards for drug substance.
Example: Bundle - Container Closure System, product | Example of Bundle - Container Closure System for drug product.
Example: Bundle - Container Closure System, substance | Example of Bundle - Container Closure System for drug substance.
Example: Bundle – Product Specification | Example of Bundle – Product Specification.
Example: Bundle – Substance Specification | Example of Bundle – Substance Specification.
Example: Bundle – Drug Product | Example of Bundle – Drug Product.
Example: Bundle – Product Microbiological Attributes | Example of Bundle – Product Microbiological Attributes.
Example: Bundle – Product Excipients | Example of Bundle – Product Excipients.
Example: Bundle – Substance General Properties | Example of Bundle – Substance General Properties.
Example: Bundle – Substance Characterization | Example of Bundle – Substance Characterization.
Example: Bundle - Impurities, product | Example of Bundle - Impurities for drug product.
Example: Bundle - Impurities, substance | Example of Bundle - Impurities for drug substance.
Example: Bundle - Manufacturing, product | Example of Bundle - Manufacturing for drug product.
Example: Bundle - Manufacturing, substance | Example of Bundle - Manufacturing for drug substance.
Example: Bundle - Organizations | Example of Bundle - Organizations for either drug product or drug substance.
Example: Bundle - Process Validation, product | Example of Bundle - Process Validation for drug product.
Example: Bundle - Process Validation, biologic product | Example of Bundle - Process Validation for biologic drug product.
Example: Bundle - Process Validation, substance | Example of Bundle - Process Validation for drug substance.
Example: Bundle – Stability, product | Example of Bundle – Stability for drug product.
Example: Bundle – Stability, substance | Example of Bundle – Stability for drug substance.

### Component Building Block Profiles

FHIR artifacts used across many pharmaceutical quality domains.

ActivityDefinition - Test | This ActivityDefinition profile represents a set of tests and their acceptance criteria through the contained ObservationDefinition resources.
Composition - Drug | This Composition profile represents narrative text necessary for pharmaceutical quality (PQ) data exchange.
DeviceDefinition - Drug | This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.
DiagnosticReport - Drug Analysis | This DiagnosticReport profile represents results from a batch analysis, stability study, characterization study, impurities analysis, manufacturing process validation study, etc.
DocumentReference - Drug | This DocumentReference profile references a document of any kind, including a diagram or image, that is necessary for pharmaceutical quality (PQ) data exchange.
Ingredient - Drug | This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance.
ManufacturedItemDefinition - Drug | This ManufacturedItemDefinition profile represents information about the physical packaged medication item, such as a tablet or capsule.
Medication - Batch Information | This Medication profile represents information about the batches that underwent testing or analysis.
MedicinalProductDefinition - Drug Product | This MedicinalProductDefinition profile represents information that identifies the drug product.
Observation - Test Result | This Observation profile represents the result of a specific test defined by an ObservationDefinition resource.
ObservationDefinition - Test Method | This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria.
Organization - Drug | This Organization profile represents information about a pharmaceutical company or site that performed drug testing or manufacturing.
PackagedProductDefinition - Drug | This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.
PlanDefinition - Drug | This PlanDefinition profile represents a protocol, analytical procedure, manufacturing process, or other workflow definition used in pharmaceutical quality (PQ) data gathering.
Procedure - Drug | This Procedure profile represents the actual performance of a manufacturing step, so that measurements can be recorded (via Observations), such as the actual “hold time” used, or the “bioburden” at the beginning or end of the step. The Procedure may record which device was used in the performance of a manufacturing step.
Specimen - Drug | This Specimen profile represents identifying information about an individual specimen (an instance).
SpecimenDefinition - Drug | This SpecimenDefinition profile represents information about the treatment of a specimen, such as storage conditions and test duration.
Substance - Drug | This Substance profile represents identifying information about an actual batch of substance (an instance).
SubstanceDefinition - Component Drug | This SubstanceDefinition profile represents the chemical or biological details about a substance associated with an active ingredient (molecular weight, molecular formula, stereochemistry, protein or nucleic acid subunits).

### Component Building Block Examples

ActivityDefinition - Test - example 1 | Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
ActivityDefinition - Test - example 2 | Example of ActivityDefinition - Test for Lyophilization.
Composition - Drug - example, formulation | Example of Composition - Drug for formulation.
Composition - Drug - example, risk | Example of Composition - Drug for risk.
DeviceDefinition - Drug - example | Example of DeviceDefinition - Drug for a Rotating Impeller with 1.5mm screen.
DiagnosticReport - Drug Analysis - example, stability | Example of DiagnosticReport - Drug Analysis for stability study results report on a drug product.
DocumentReference - Drug - example | Example of DocumentReference - Drug for process flow diagram.
Ingredient - Drug - example | Example of Ingredient - Drug containing one substance.
ManufacturedItemDefinition - Drug - example 1 | Example of ManufacturedItemDefinition - Drug for an item contained by a closure system.
ManufacturedItemDefinition - Drug - example 2 | Example of ManufacturedItemDefinition - Drug for Stelbatolol 5mg tablet.
Medication - Batch Information - example | Example of Medication - Batch Information for actual batch with lot number 33445.
MedicinalProductDefinition - Drug Product - example | Example of MedicinalProductDefinition - Drug Product for Stelbat Tablets, 20mg.
Observation - Test Result - example 1 | Example of Observation - Test Result of Degradation Product ‘Impurity 1’ description from longTerm25X test.
Observation - Test Result - example 2 | Example of Observation - Test Result of Degradation Product ‘Impurity 1’ quality from longTerm25X test.
ObservationDefinition - Test Method - example 1, longTerm25X | Example of ObservationDefinition - Test Method for longTerm25X test for stability.
ObservationDefinition - Test Method - example 2, Water | Example of ObservationDefinition - Test Method for Water Content test method.
Organization - Drug - example 1, manufacturer | Example of Organization - Drug.
Organization - Drug - example 2, manufacturer | Example of Organization - Drug.
Organization - Drug - example 3, packaging | Example of Organization - Drug.
Organization - Drug - example 4, packaging | Example of Organization - Drug.
Organization - Drug - example 5, testing lab | Example of Organization - Drug.
PackagedProductDefinition - Drug - example | Example of PackagedProductDefinition - Drug.
PlanDefinition - Drug - example, validation protocol | Example of PlanDefinition - Drug for validation protocol.
PlanDefinition - Drug - example, manufacturing plan | Example of PlanDefinition - Drug for manufacturing plan
PlanDefinition - Drug - example, drug specification | Example of PlanDefinition - Drug for drug specification.
PlanDefinition - Drug - example, manufacturing process | Example of PlanDefinition - Drug for manufacturing process.
PlanDefinition - Drug - example, stability study protocol | Example of PlanDefinition - Drug for stability study protocol.
Procedure - Drug - example 1 | Example of Procedure - Drug for Media Challenge, Run 1.
Procedure - Drug - example 2 | Example of Procedure - Drug for Lyophilization Homogeneity.
Specimen - Drug - example | Example of Specimen - Drug with collection date/time and processing descriptions.
SpecimenDefinition - Drug - example 1 | Example of SpecimenDefinition - Drug for specimen stored at 25°C.
SpecimenDefinition - Drug - example 2 | Example of SpecimenDefinition - Drug for specimen stored at 30°C.
SpecimenDefinition - Drug - example 3 | Example of SpecimenDefinition - Drug for specimen stored at 40°C.
Substance - Drug - example | Example of Substance - Drug.
SubstanceDefinition - Component Drug - example 1 | Example of SubstanceDefinition - Component Drug, Stelbatolol.
SubstanceDefinition - Component Drug - example 2 | Example of SubstanceDefinition - Component Drug, Stelbatolol Aqueous Solution.
SubstanceDefinition - Component Drug - example 3 | Example of SubstanceDefinition - Component Drug, Stelbatolol Granules.
accelerated40X | ObservationDefinition - accelerated40X
accelerated40Y | ObservationDefinition - accelerated40Y
accelerated40Z | ObservationDefinition - accelerated40Z
longTerm25Y | ObservationDefinition - longTerm25Y
longTerm25Z | ObservationDefinition - longTerm25Z
longTerm30X | ObservationDefinition - longTerm30X
longTerm30Y | ObservationDefinition - longTerm30Y
Assay | ObservationDefinition - Assay
Degradation | ObservationDefinition - Degradation
Description | ObservationDefinition - Description
Identification | ObservationDefinition - Identification
Impurities | ObservationDefinition - Impurities
Microbiological | ObservationDefinition - Microbiological
Uniformity | ObservationDefinition - Uniformity
observation-test-result-longterm25c-initial-1 | observation-test-result-longterm25c-initial-1
observation-test-result-lt25c-i1-degradation-imp2 | observation-test-result-lt25c-i1-degradation-imp2
observation-test-result-lt25c-i1-degradation-imp3 | observation-test-result-lt25c-i1-degradation-imp3
observation-test-result-lt25c-i1-degradation-imp-total | observation-test-result-lt25c-i1-degradation-imp-total
observation-test-result-lt25c-i1-degradation-imp-unspecified | observation-test-result-lt25c-i1-degradation-imp-unspecified
observation-test-result-lt25c-i1-microbiological | observation-test-result-lt25c-i1-microbiological
observation-test-result-lt25c-i1-uniformity | observation-test-result-lt25c-i1-uniformity
observation-test-result-lt25c-i1-water | observation-test-result-lt25c-i1-water

### Extensions

Extension - Actual Yield | The actual weight of a batch
Extension - Actual Yield Unfiltered | The actual weight of a batch, before filtering
Extension - Batch Derived From | A reference to another batch that this batch is derived from
Extension - Batch Designation | A batch’s type in terms of its general size
Extension - Batch Number of Items | The number of items (e.g., tablets) produced in a manufacturing batch.
Extension - Batch Number of Full Shelves | The count of full shelves from which batches are selected for testing
Extension - Batch Number of Partial Shelves | The number of partially filled shelves from which batches are selected for testing
Extension - Batch Number of Vials | The count of vials selected for testing
Extension - Batch Release Date | The date when a batch was made available
Extension - Batch Retest Date | The date that a batch is due to be tested again
Extension - Batch Storage Duration | The length of time for which a batch is stored, before being tested
Extension - Batch Substance Batch | A reference to a substance that this batch consists of
Extension - Container Orientation | The spatial orientation of the container when tested, for instance horizontal or vertical
Extension - Formulation Number | An identifying number for the particular substance formulation in the batch
Extension - History of Process | A textual description of the previous versions, decisions and development of this process
Extension - Impurity Origin | Extension - Impurity Origin
Extension - Manufacturing Participant | A reference to a substance that takes part in a process step
Extension - Manufacturing Process | A reference to the process of manufacture of this batch (PlanDefinition)
Extension - Medication Definition | The MedicinalProductDefinition that corresponds to a medication
Extension - Novel Excipient | Whether or not an excipient (inactive ingredient) in a product is considered ‘novel’
Extension - Package Definition | A reference to the packaging for a medication (PackagedProductDefinition)
Extension - Packaging Date | The date when the batch was packaged
Extension - Packaging Site | The organization that packaged this batch (reference to an Organization)
Extension - Plan Document Reference | A link to a document or image that describes the process of this plan
Extension - Process Parameters | A property value or setting that this process step must use, e.g., a certain temperature or duration
Extension - Process Step Scale | A scale size description that applies to a process step, such as ‘production’ or ‘laboratory’
Extension - Qualified Value Criticality | A measure of how important the control value of this process step is
Extension - Qualified Value Display | A displayable version of a qualified value, formatted for showing to a user
Extension - Qualified Value Target | A target, desired, amount for a qualified value, from within the allowable range
Extension - Qualified Value Text | A string based acceptable range description
Extension - Site Utilization | The role that the site performs, in the overall context of manufacturing
Extension - Statistical Model | Information about the statistical model utilized to interpret results
Extension - Substance Property Parameter | A parameter to a substance property, such as the concentration or pH at which the property value applies
Extension - Substance Property Range | Allows a characteristic or property to use a range datatype, instead of a single value
Extension - Suitability For Use | Whether an excipient is considered suitable for use in this product or item
Extension - Target Fill Weight | The desired amount of substance in each item to be made from the batch (e.g., a vial)
Extension - Test Comment | A textual comment that further describes an aspect of a test requirement
Extension - Time Point Description | A code that further describes a time point, such as ‘delayed start’

### Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Batch Designation | This value set contains codes for batch designation.
Characterization Steps | This value set contains codes for structure characterization technique.
Closure Types | This value set contains codes for closure types.
Colors | This value set contains codes for drug substance or product color.
Container Orientations | This value set contains codes for container orientation.
Device Properties | This value set contains codes for device property.
Device Type | This value set contains example codes for device type in pharmaceutical quality industry.
Diagram Types | This value set contains codes for diagram type.
Equipment Classes | This value set contains codes for manufacturing equipment class.
Goal Priority | This value set contains example codes for goal priority used in pharmaceutical quality industry.
Grades | This value set contains codes for package grade.
ISO Country two letter codes | This value set contains codes for ISO Country two letter codes.
Impurity Origins | This value set contains codes for impurity origin.
Impurity Types | This value set contains codes for impurity type.
Ingredient Function | This value set contains codes for ingredient function.
Manufactured Item Property | This value set contains example codes for manufactured item property in pharmaceutical quality industry.
Manufacturing Participant Role | This value set contains codes for manufacturing participant.
Manufacturing Step | This value set contains codes for manufacturing step.
Manufacturing Step Scale | This value set contains codes for manufacturing step scale.
MedicinalProduct Characteristic Type | Example codes for MedicinalProduct.characteristic.type
Medicine Dose Form EDQM | EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. This Value Set includes all the EDQM Standard Terms having: [Concept Status] = ‘Current’ AND [Concept Class] IN (‘PDF’, ‘CMT’, ‘CDF’, ‘PFT’) AND [Domain] = ‘Human and Veterinary’ PDF = ‘Pharmaceutical dose form’; CMT = ‘Combined terms’; CDF = ‘Combined pharmaceutical dose form’; PFT = ‘Patient Friendly’
Medicine Route of Administration EDQM | EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. This Value Set includes all the EDQM Standard Terms having: [Concept Status] = ‘Current’ AND [Concept Class] = ‘ROA’ AND [Domain] = ‘Human and Veterinary’ ROA = ‘Route of administration’
Package Property | This value set contains codes for package property.
Pharmaceutical Organization Type | This value set contains codes for pharmaceutical organization types.
Plan Type | This value set contains codes for pharmaceutical plan type.
Process Parameter | This value set contains codes for process parameter.
Process Validation Procedure | This value set contains example process validation procedure codes for use in pharmaceutical quality industry.
Product Name Type | This value set contains example codes for product name type in pharmaceutical quality industry.
Product Site Utilization | This value set contains codes for product site utilization type.
Qualified Value Criticality | This value set contains example codes for observation qualified value criticality.
Report Type | This value set contains codes for pharmaceutical report type.
Specification Type | This value set contains example codes for specification type in pharmaceutical quality industry.
Substance Property | This value set contains example codes for substance property types in pharmaceutical quality industry.
Substance Property Value | This value set contains example codes for substance property values in pharmaceutical quality industry.
Test Category | This value set contains codes for test category.
Test Method | This value set contains example codes for test methods in pharmaceutical quality industry.
Time Point Description | This value set contains codes for time point description.

### Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Batch Designation Codes | This code system contains codes for batch designation in pharmaceutical quality.
Closure Type Codes | This code system contains codes for closure type.
Container Orientation Codes | This code system contains codes for container orientation.
Device Property Codes | This code system contains codes for device property.
Device Type - example | This example code system contains example codes for device type used in pharmaceutical quality industry.
Diagram Type Codes | This code system contains codes for diagram type.
Drug Substance or Product Color Codes | This code system contains codes for color in drug substances or products.
Example Local Codes - Drug | This example code system contains temporary example codes used in pharmaceutical quality industry.
Goal Priority - example | This example code system contains example codes for goal priority used in pharmaceutical quality industry.
Impurity Origin Codes | This code system contains codes for impurity origin.
Impurity Type Codes | This code system contains codes for impurity type.
Ingredient Function Codes | This code system contains codes for ingredient function.
Manufactured Item Property - example | This example code system contains example codes for manufactured item property used in pharmaceutical quality industry.
Manufacturing Participant Role Codes | This code system contains codes for manufacturing participant role.
Manufacturing Step Codes | This code system contains codes for manufacturing step.
Manufacturing Step Scale Codes | This code system contains codes for manufacturing step scale.
Observation Qualified Value Criticality Codes | This code system contains codes for observation qualified value criticality.
Package Grade Codes | This code system contains codes for package grade.
Package Property Codes | This code system contains codes for package property.
Pharmaceutical Manufacturing Equipment Class Codes | This code system contains codes for pharmaceutical manufacturing equipment class.
Pharmaceutical Organization Type Codes | This code system contains codes for pharmaceutical organization type.
Pharmaceutical Plan Type Codes | This code system contains codes for pharmaceutical plan type.
Pharmaceutical Report Type Codes | This code system contains codes for pharmaceutical report type.
Pharmaceutical Test Category Codes | This code system contains codes for pharmaceutical test category.
Process Parameter Codes | This code system contains codes for process parameter.
Product Name Type - example | This example code system contains example codes for product name type used in pharmaceutical quality industry.
Product Site Utilization Type Codes | This code system contains codes for product site utilization type.
Specification Type - example | This example code system contains example codes for specification type used in pharmaceutical quality industry.
Structure Characterization Technique Codes | This code system contains codes for structure characterization technique in pharmaceutical quality.
Substance Property - example | This example code system contains example codes for substance property types used in pharmaceutical quality industry.
Substance Property Value - example | This example code system contains example codes for substance property values used in pharmaceutical quality industry.
Time Point Description Codes | This code system contains codes for time point description.