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.

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.

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.

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.

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.

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.

Composition domain: This Bundle profile represents the structured data used in CTD section 3.2.P.1 Description and Composition of the Drug Product.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Example of Bundle – Analytical Procedure for drug product.

Example of Bundle – Analytical Procedure for drug substance.

Example of Bundle – Batch Analysis for drug product.

Example of Bundle – Batch Analysis for drug substance.

Example of Bundle - Batch Formula for drug product.

Example of Bundle – Product Batch Information.

Example of Bundle – Substance Batch Information.

Example of Bundle – Product Compatibility.

Example of Bundle – Product Composition.

Example of Bundle – Reference Standards for drug substance.

Example of Bundle - Container Closure System for drug product.

Example of Bundle - Container Closure System for drug substance.

Example of Bundle – Product Specification.

Example of Bundle – Substance Specification.

Example of Bundle – Drug Product.

Example of Bundle – Product Microbiological Attributes.

Example of Bundle – Product Excipients.

Example of Bundle – Substance General Properties.

Example of Bundle – Substance Characterization.

Example of Bundle - Impurities for drug product.

Example of Bundle - Impurities for drug substance.

Example of Bundle - Manufacturing for drug product.

Example of Bundle - Manufacturing for drug substance.

Example of Bundle - Organizations for either drug product or drug substance.

Example of Bundle - Process Validation for drug product.

Example of Bundle - Process Validation for biologic drug product.

Example of Bundle - Process Validation for drug substance.

Example of Bundle – Stability for drug product.

Example of Bundle – Stability for drug substance.

This ActivityDefinition profile represents a set of tests and their acceptance criteria through the contained ObservationDefinition resources.

This Composition profile represents narrative text necessary for pharmaceutical quality (PQ) data exchange.

This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.

This DiagnosticReport profile represents results from a batch analysis, stability study, characterization study, impurities analysis, manufacturing process validation study, etc.

This DocumentReference profile references a document of any kind, including a diagram or image, that is necessary for pharmaceutical quality (PQ) data exchange.

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.

This ManufacturedItemDefinition profile represents information about the physical packaged medication item, such as a tablet or capsule.

This Medication profile represents information about the batches that underwent testing or analysis.

This MedicinalProductDefinition profile represents information that identifies the drug product.

This Observation profile represents the result of a specific test defined by an ObservationDefinition resource.

This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria.

This Organization profile represents information about a pharmaceutical company or site that performed drug testing or manufacturing.

This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.

This PlanDefinition profile represents a protocol, analytical procedure, manufacturing process, or other workflow definition used in pharmaceutical quality (PQ) data gathering.

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.

This Specimen profile represents identifying information about an individual specimen (an instance).

This SpecimenDefinition profile represents information about the treatment of a specimen, such as storage conditions and test duration.

This Substance profile represents identifying information about an actual batch of substance (an instance).

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).

Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.

Example of ActivityDefinition - Test for Lyophilization.

Example of Composition - Drug for formulation.

Example of Composition - Drug for risk.

Example of DeviceDefinition - Drug for a Rotating Impeller with 1.5mm screen.

Example of DiagnosticReport - Drug Analysis for stability study results report on a drug product.

Example of DocumentReference - Drug for process flow diagram.

Example of Ingredient - Drug containing one substance.

Example of ManufacturedItemDefinition - Drug for an item contained by a closure system.

Example of ManufacturedItemDefinition - Drug for Stelbatolol 5mg tablet.

Example of Medication - Batch Information for actual batch with lot number 33445.

Example of MedicinalProductDefinition - Drug Product for Stelbat Tablets, 20mg.

Example of Observation - Test Result of Degradation Product ‘Impurity 1’ description from longTerm25X test.

Example of Observation - Test Result of Degradation Product ‘Impurity 1’ quality from longTerm25X test.

Example of ObservationDefinition - Test Method for longTerm25X test for stability.

Example of ObservationDefinition - Test Method for Water Content test method.

Example of Organization - Drug.

Example of Organization - Drug.

Example of Organization - Drug.

Example of Organization - Drug.

Example of Organization - Drug.

Example of PackagedProductDefinition - Drug.

Example of PlanDefinition - Drug for validation protocol.

Example of PlanDefinition - Drug for manufacturing plan

Example of PlanDefinition - Drug for drug specification.

Example of PlanDefinition - Drug for manufacturing process.

Example of PlanDefinition - Drug for stability study protocol.

Example of Procedure - Drug for Media Challenge, Run 1.

Example of Procedure - Drug for Lyophilization Homogeneity.

Example of Specimen - Drug with collection date/time and processing descriptions.

Example of SpecimenDefinition - Drug for specimen stored at 25°C.

Example of SpecimenDefinition - Drug for specimen stored at 30°C.

Example of SpecimenDefinition - Drug for specimen stored at 40°C.

Example of Substance - Drug.

Example of SubstanceDefinition - Component Drug, Stelbatolol.

Example of SubstanceDefinition - Component Drug, Stelbatolol Aqueous Solution.

Example of SubstanceDefinition - Component Drug, Stelbatolol Granules.

ObservationDefinition - accelerated40X

ObservationDefinition - accelerated40Y

ObservationDefinition - accelerated40Z

ObservationDefinition - longTerm25Y

ObservationDefinition - longTerm25Z

ObservationDefinition - longTerm30X

ObservationDefinition - longTerm30Y

ObservationDefinition - Assay

ObservationDefinition - Degradation

ObservationDefinition - Description

ObservationDefinition - Identification

ObservationDefinition - Impurities

ObservationDefinition - Microbiological

ObservationDefinition - Uniformity

observation-test-result-longterm25c-initial-1

observation-test-result-lt25c-i1-degradation-imp2

observation-test-result-lt25c-i1-degradation-imp3

observation-test-result-lt25c-i1-degradation-imp-total

observation-test-result-lt25c-i1-degradation-imp-unspecified

observation-test-result-lt25c-i1-microbiological

observation-test-result-lt25c-i1-uniformity

observation-test-result-lt25c-i1-water

The actual weight of a batch

The actual weight of a batch, before filtering

A reference to another batch that this batch is derived from

A batch’s type in terms of its general size

The number of items (e.g., tablets) produced in a manufacturing batch.

The count of full shelves from which batches are selected for testing

The number of partially filled shelves from which batches are selected for testing

The count of vials selected for testing

The date when a batch was made available

The date that a batch is due to be tested again

The length of time for which a batch is stored, before being tested

A reference to a substance that this batch consists of

The spatial orientation of the container when tested, for instance horizontal or vertical

An identifying number for the particular substance formulation in the batch

A textual description of the previous versions, decisions and development of this process

Extension - Impurity Origin

A reference to a substance that takes part in a process step

A reference to the process of manufacture of this batch (PlanDefinition)

The MedicinalProductDefinition that corresponds to a medication

Whether or not an excipient (inactive ingredient) in a product is considered ‘novel’

A reference to the packaging for a medication (PackagedProductDefinition)

The date when the batch was packaged

The organization that packaged this batch (reference to an Organization)

A link to a document or image that describes the process of this plan

A property value or setting that this process step must use, e.g., a certain temperature or duration

A scale size description that applies to a process step, such as ‘production’ or ‘laboratory’

A measure of how important the control value of this process step is

A displayable version of a qualified value, formatted for showing to a user

A target, desired, amount for a qualified value, from within the allowable range

A string based acceptable range description

The role that the site performs, in the overall context of manufacturing

Information about the statistical model utilized to interpret results

A parameter to a substance property, such as the concentration or pH at which the property value applies

Allows a characteristic or property to use a range datatype, instead of a single value

Whether an excipient is considered suitable for use in this product or item

The desired amount of substance in each item to be made from the batch (e.g., a vial)

A textual comment that further describes an aspect of a test requirement

A code that further describes a time point, such as ‘delayed start’

This value set contains codes for batch designation.

This value set contains codes for structure characterization technique.

This value set contains codes for closure types.

This value set contains codes for drug substance or product color.

This value set contains codes for container orientation.

This value set contains codes for device property.

This value set contains example codes for device type in pharmaceutical quality industry.

This value set contains codes for diagram type.

This value set contains codes for manufacturing equipment class.

This value set contains example codes for goal priority used in pharmaceutical quality industry.

This value set contains codes for package grade.

This value set contains codes for ISO Country two letter codes.

This value set contains codes for impurity origin.

This value set contains codes for impurity type.

This value set contains codes for ingredient function.

This value set contains example codes for manufactured item property in pharmaceutical quality industry.

This value set contains codes for manufacturing participant.

This value set contains codes for manufacturing step.

This value set contains codes for manufacturing step scale.

Example codes for MedicinalProduct.characteristic.type

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’

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’

This value set contains codes for package property.

This value set contains codes for pharmaceutical organization types.

This value set contains codes for pharmaceutical plan type.

This value set contains codes for process parameter.

This value set contains example process validation procedure codes for use in pharmaceutical quality industry.

This value set contains example codes for product name type in pharmaceutical quality industry.

This value set contains codes for product site utilization type.

This value set contains example codes for observation qualified value criticality.

This value set contains codes for pharmaceutical report type.

This value set contains example codes for specification type in pharmaceutical quality industry.

This value set contains example codes for substance property types in pharmaceutical quality industry.

This value set contains example codes for substance property values in pharmaceutical quality industry.

This value set contains codes for test category.

This value set contains example codes for test methods in pharmaceutical quality industry.

This value set contains codes for time point description.

This code system contains codes for batch designation in pharmaceutical quality.

This code system contains codes for closure type.

This code system contains codes for container orientation.

This code system contains codes for device property.

This example code system contains example codes for device type used in pharmaceutical quality industry.

This code system contains codes for diagram type.

This code system contains codes for color in drug substances or products.

This example code system contains temporary example codes used in pharmaceutical quality industry.

This example code system contains example codes for goal priority used in pharmaceutical quality industry.

This code system contains codes for impurity origin.

This code system contains codes for impurity type.

This code system contains codes for ingredient function.

This example code system contains example codes for manufactured item property used in pharmaceutical quality industry.

This code system contains codes for manufacturing participant role.

This code system contains codes for manufacturing step.

This code system contains codes for manufacturing step scale.

This code system contains codes for observation qualified value criticality.

This code system contains codes for package grade.

This code system contains codes for package property.

This code system contains codes for pharmaceutical manufacturing equipment class.

This code system contains codes for pharmaceutical organization type.

This code system contains codes for pharmaceutical plan type.

This code system contains codes for pharmaceutical report type.

This code system contains codes for pharmaceutical test category.

This code system contains codes for process parameter.

This example code system contains example codes for product name type used in pharmaceutical quality industry.

This code system contains codes for product site utilization type.

This example code system contains example codes for specification type used in pharmaceutical quality industry.

This code system contains codes for structure characterization technique in pharmaceutical quality.

This example code system contains example codes for substance property types used in pharmaceutical quality industry.

This example code system contains example codes for substance property values used in pharmaceutical quality industry.

This code system contains codes for time point description.