This Bundle profile represents the structured data 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.

Example of Bundle – Analytical Procedure for drug product.

Example of Bundle – Analytical Procedure for drug substance.

This Bundle profile represents the structured data 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.

Example of Bundle – Batch Analysis for drug product.

Example of Bundle – Batch Analysis for drug substance.

This Bundle profile represents the structured data in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.2 Batch Formula.

Example of Bundle - Batch Formula for drug product.

This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses.

This Bundle profile represents the structured data in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.

Example of Bundle – Product Batch Information.

Example of Bundle – Substance Batch Information.

This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.6 Compatibility.

Example of Bundle – Product Compatibility.

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

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.

Example of Bundle – Product Composition.

Example of Bundle – Reference Standards for drug substance.

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.

Example of Bundle - Container Closure System for drug product.

Example of Bundle - Container Closure System for drug substance.

This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.1 Specification(s).

This Bundle profile represents the structured data in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification.

Example of Bundle – Product Specification.

Example of Bundle – Substance Specification.

This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.2 Drug Product.

This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.5 Microbiological Attributes.

This Bundle profile represents the structured data 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.

This Bundle profile represents the structured data in CTD section 3.2.S.1 General Information, subsection 3.2.S.1.3 General Properties.

This Bundle profile represents the structured data in CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.1 – Elucidation of Structure and Other Characteristics.

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.

This Bundle profile represents the structured data 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.

Example of Bundle - Impurities for drug product.

Example of Bundle - Impurities for drug substance.

This Bundle profile represents the structured data 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.

Example of Bundle - Manufacturing for drug product.

Example of Bundle - Manufacturing for drug substance.

This Bundle profile represents the structured data 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).

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

This Bundle profile represents the structured data 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.

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.

This Bundle profile represents the structured data 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 – 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 aubstance (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 containung 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’ qualtity 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 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 Homogeneneity.

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.

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 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 orientaton of the container when tested, for instance horizontal or vertical

An identifying number for the particular substance formulation in the batch

An 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 doucment, 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’

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

Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

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 example codes for batch designation in PQ.

This value set contains example codes for container orientation in PQ.

This value set contains example codes for device property in PQ.

This valueset contains example codes for device type in PQ.

This value set contains example codes for impurity origin in PQ.

This value set contains example codes for ingredient function in PQ.

This value set contains example codes for manufactured item property in PQ.

This value set contains example codes for manufacturing step in PQ.

This value set contains example codes for manufacturing step scale in PQ.

This value set contains example codes for package property in PQ.

This value set contains example codes for plan type in PQ.

This value set contains example process validation procedure codes for use in PQ.

This value set contains example codes for product site utilization type in PQ.

This value set contains example codes for qualified value criticality in PQ.

This value set contains example codes for test methods in PQ.

This value set contains example codes for time point description in PQ.

This code system contains example codes for batch designation in PQ.

This code system contains example codes for characterization step in PQ.

This code system contains example codes for closure types in PQ.

This code system contains example codes for color in PQ.

This code system contains example codes for container orientation in PQ.

This code system contains example codes for control criticality in PQ.

This code system contains example codes for device property in PQ.

This code system contains example codes for device type in PQ.

This code system contains example codes for diagram type in PQ.

This code system contains example codes for equipment class in PQ.

This code system contains temporary example codes for use in PQ.

This code system contains example codes for goal priority in PQ.

This code system contains example codes for grade in PQ.

This code system contains example codes for ICH M7 classification in PQ.

This code system contains example codes for impurity origin in PQ.

This code system contains example codes for impurity type in PQ.

This code system contains example codes for ingredient function in PQ.

This code system contains example codes for manufactured item property in PQ.

This code system contains example codes for manufacturing participant role in PQ.

This code system contains example codes for manufacturing step in PQ.

This code system contains example codes for manufacturing step scale in PQ.

This code system contains example codes for mutagenicity in PQ.

This code system contains example codes for mutagenicity classification type in PQ.

This code system contains example codes for package property in PQ.

This code system contains example codes for plan type in PQ.

This code system contains example codes for process parameter in PQ.

This code system contains example codes for product name type in PQ.

This code system contains example codes for product site utilization type in PQ.

This code system contains example codes for qualified value criticality in PQ.

This code system contains example codes for report type in PQ.

This code system contains example codes for specification type in PQ.

This code system contains example codes for substance property in PQ.

This code system contains example codes for substance property solubility in PQ.

This code system contains example codes for substance property type in PQ.

This code system contains example codes for test category in PQ.

This code system contains example codes for time point description in PQ.