Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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-ballot 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

Example Bundle: Example: Bundle – Product Excipients

Bundle bundle-drug-product-excipients-pq-ex1 of type collection


Entry 1 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"

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.

combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)

route: Oral use (standardterms.edqm.eu#20053000)

Names

-ProductNameType
*StalbatololProprietary (CodeSystem - Product Name Type#Proprietary)

characteristic

Extension - Substance Property Range PQ: 23-27 mg/mL

type: Solubility purified water (CodeSystem - Substance Property#solubility-water)

characteristic

type: Water content (CodeSystem - Substance Property#water-content)

value: 23 mg/mL


Entry 2 - fullUrl = urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616b

Resource Organization:

Generated Narrative: Organization

Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616b"

identifier: urn:oid:2.16.840.1.113883.4.82/3010027651

name: Modified Sugar, Inc.

Contacts

-Address
*381 Main Street Lumberton New Jersey 08048 USA


Entry 3 - fullUrl = urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616c

Resource Organization:

Generated Narrative: Organization

Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616c"

identifier: urn:oid:2.16.840.1.113883.4.82/3012027651

name: Plasma Source, Inc.

Contacts

-Address
*351 Main Street Lumberton New Jersey 08048 USA


Entry 4 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b"

Extension - Novel Excipient PQ: true

Extension - Suitability for Use PQ: Excipient has been certified for use in human medicinal products

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616b)

substance

Codes

-Reference
*See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474)


Entry 5 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380474"

Names

-Name
*Pegylated glucose

SourceMaterials

-TypeCountryOfOrigin
*mineral (Substance Source Material Type#Mineral)United Kingdom (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#GBR)


Entry 6 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b"

Extension - Suitability for Use PQ: 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.

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616c)

substance

Codes

-Reference
*See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475)


Entry 7 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380475"

Names

-Name
*Deactivated goat albumin

SourceMaterials

-TypeSpeciesPartCountryOfOrigin
*animal (Substance Source Material Type#Animal)animal (Substance Source Material Part#Animal)animal (Substance Source Material Type#Animal)United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)