Pharmaceutical Quality (Industry)
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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. . For a full list of available versions, see the Directory of published versions

Identification: CMC synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.5 Characterisation of Impurities.

The section 3.2.S.3 Characterisation, subsection 3.2.S.3.2 Impurities, is similar.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

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Bundle [documentation R4 R5 R6]
id: bundle-drug-product-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-pq
Type: collection
Warning - Found Composition as first Bundle entry, but not in a document Bundle
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-pq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stalbatolol
Characteristic
Type: Physicochemical properties [physicochemical] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: Product properties with cross reference to other dossier sections as 3.2.P.5.1 Consider parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity. Any properties which are not included in the product specification, with explanation of parameter control and relevant studies. If applicable refer to relevant compendia monograph
Characteristic
Type: pH [pH] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 7.0
Characteristic
Type: Ionic Strength [ionic-strength] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 23 mg/mL
Comprised Of
Found a parent (MedicinalProductDefinition/comprisedOf, id: medicinalproductdefinition-drug-product-pq-ex1 fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Manufactured Item [documentation R4 R5 R6]
id: manufactureditemdefinition-drug-pq-ex2
fullUrl: urn:uuid:1531c777-50c3-047d-2798-de3d001d2c44
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq
Name: Stelbatolol 5mg tablet
Status: active
Property
Type: Overage by mass (%) [overage-by-mass] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufactured-item-property-local-pq)
Value: 5%
Property
Type: Overage reason [overage-reason] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufactured-item-property-local-pq)
Value: Overage is necessary because...
Composition [documentation R4 R5 R6]
id: comp-drug-components
fullUrl: urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5
Type: Product Note - Drug Components
Date: 2023-10-01
Status: final
Title: 3.2.P.2.1.1 - Components of the Drug Product
Author
Found a parent (Composition/author, id: comp-drug-components fullUrl: urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-formulation fullUrl: urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-risk fullUrl: urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-drug-pq-ex1
fullUrl: urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Name: AAA Molybdenum Products, Inc.
Section
Title: 3.2.P.2.1.1.1 - Drug Substance
Text
Status: additional

The compatibility of the drug substance with the excipients listed in 3.2.P.1 should be discussed. Additionally, key physicochemical characteristics (eg, water content, solubility, particle size distribution, polymorphic or solid state form) of the drug substance that can influence the performance of the drug product should be discussed.

For combination products, the compatibility of drug substances with each other should be discussed.

Section
Title: 3.2.P.1.1.2 - Excipients
Text
Status: additional

The choice of excipients listed in 3.2.P.1, their concentration, and the characteristics that can influence the drug product manufacturability and performance should be discussed relative to their respective functions.

Composition [documentation R4 R5 R6]
id: composition-drug-pq-formulation
fullUrl: urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq
Type: Product Note - Formulation Development
Date: 2023-10-01
Status: final
Title: 3.2.P.2.2.1 - Formulation Development
Author
Found a parent (Composition/author, id: comp-drug-components fullUrl: urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-formulation fullUrl: urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-risk fullUrl: urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-drug-pq-ex1
fullUrl: urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Name: AAA Molybdenum Products, Inc.
Section
Title: 3.2.P.2.2.1.1 - Formulation History
Text
Status: additional
  • Drug product description including difference or similarity between the drug product and reference product, if applicable
  • Propose route of administration (include any dilution or reconstitution necessary)
  • Choice of manufacturing process, explain choice if alternative process could have been applicable (e.g. aseptic processing instead of terminal sterilization, direct compression instead of granulation). If different processes were used for different formulation highlight and explain differences, refer at 3.2.P.2.3. If no change in the process occurred refer to 3.3.P.3.3 and avoid duplication data.

Table 1 - Formulation history for Stelbatolol

Formulation Identifier Composition Change Development phase
1233545 Composition 1a Changes made are listed here Pre-clinical phase
Section
Title: 3.2.P.2.2.1.2 - Formulation Development Studies
Text
Status: additional

Summary of the formulation developmental studies conducted are provided in Table 2

Table 2 - Formulation Development Studies

Study Formulation identifier Objective Quality attribute evaluated Study design Study result
Study Name 12234a Short description of the study objective CQA information Short description of the design Reference to the table showing study results
Section
Title: 3.2.P.2.2.4 - Summary for Risk Assessment of Elemental Impurities in Drug Product
Text
Status: additional

Summary of the risk assessment for product...

Composition [documentation R4 R5 R6]
id: composition-drug-pq-risk
fullUrl: urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq
Type: Product Note - Summary for Risk of Impurities
Date: 2023-10-01
Status: final
Title: 3.2.P.2.2.4 - Summary for Risk of Impurities
Author
Found a parent (Composition/author, id: comp-drug-components fullUrl: urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-formulation fullUrl: urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Found a parent (Composition/author, id: composition-drug-pq-risk fullUrl: urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-drug-pq-ex1
fullUrl: urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d
- AAA Molybdenum Products, Inc.
Name: AAA Molybdenum Products, Inc.
Section
Text
Status: additional

Text for the risk assessment of elemental impurities in the product