Pharmaceutical Quality (Industry)
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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

Identification: synthetic data rendering - drug product excipients

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.4 Control of Excipients, subsections 3.2.P.4.5 Excipients of Human or Animal Origin & 3.2.P.4.6 Novel Excipients.

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.

Bundle [documentation R4 R5 R6]
id: bundle-drug-product-excipients-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-excipients-pq
Type: collection
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stalbatolol
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)
Description: Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
Characteristic
Type: Solubility purified water [solubility-water] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example)
Value: from 23 mg/mL to 27 mg/mL
Characteristic
Type: Water content [water-content] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example)
Value: 23 mg/mL

Excipients

Novel Excipients

Excipient Biological Source Country of Origin Manufacturer Suitability for Use
Pegylated glucose mineral United Kingdom Modified Sugar, Inc. Excipient has been certified for use in human medicinal products


Excipients of Human or Animal Origin

Excipient Biological Source Country of Origin Manufacturer Suitability for Use
Deactivated goat albumin animal United States of America Plasma Source, Inc. Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials.

Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: ingredient1
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Novel Excipient?: true
Suitability for Use: Excipient has been certified for use in human medicinal products
Substance
Found a parent (Ingredient/code, id: ingredient1 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b)
which is linked to this by resource.id
Substance - Pegylated glucose [documentation R4 R5 R6]
id: pg
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474
Name: Pegylated glucose
Source Material
Type: mineral [Mineral] (http://hl7.org/fhir/substance-source-material-type)
Country of Origin: United Kingdom [GBR] (urn:iso:std:iso:3166)
Manufacturer
Found a parent (Ingredient/manufacturer, id: ingredient1 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturerPG
fullUrl: urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616b
- Modified Sugar, Inc.
Identifier: 3010027651 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Modified Sugar, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 381 Main Street, Lumberton, New Jersey, 08048, USA
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: ingredient2
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Suitability for Use: Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials.
Substance
Found a parent (Ingredient/code, id: ingredient2 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b)
which is linked to this by resource.id
Substance - Deactivated goat albumin [documentation R4 R5 R6]
id: dga
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475
Name: Deactivated goat albumin
Source Material
Type: animal [Animal] (http://hl7.org/fhir/substance-source-material-type)
Species: animal [Animal] (http://hl7.org/fhir/substance-source-material-part)
Part: animal [Animal] (http://hl7.org/fhir/substance-source-material-type)
Country of Origin: United States of America [USA] (urn:iso:std:iso:3166)
Manufacturer
Found a parent (Ingredient/manufacturer, id: ingredient2 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturerDGA
fullUrl: urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616c
- Plasma Source, Inc.
Identifier: 3012027651 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Plasma Source, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 351 Main Street, Lumberton, New Jersey, 08048, USA