Pharmaceutical Quality (Industry)
1.0.0 - STU1 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 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 Specification

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

Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex3-drug-specification"

url: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a

title: SPECIFICATION(S) FOR DRUG PRODUCT

status: ACTIVE

subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

description: Narrative description of specifications

action

title: Specification(s) for Drug Product

code: Overall set of actions ()

action

action

Entry 2 - fullUrl = urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "77e7020a-270c-6bed-2e55-28e9e942546c"

url: http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c

title: Description

status: ACTIVE

code: Description (Example Local Codes - Drug#DESC)

method: Visual inspection ()

QualifiedValues

-Extension
*

Entry 3 - fullUrl = urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "d24ce3cd-213d-4935-97cf-8e2dd03721ec"

url: http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec

title: Description

status: ACTIVE

code: Description (Example Local Codes - Drug#DESC)

QualifiedValues

-Extension
*

Entry 4 - fullUrl = urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"

url: http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12

title: Identification

status: ACTIVE

code: Identification (Example Local Codes - Drug#IDT)

method: ID by UHPLC ()

QualifiedValues

-Extension
*

Entry 5 - fullUrl = urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "f77ba972-5ef8-a178-9a5f-fe7f54da7499"

url: http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499

title: Identification

status: ACTIVE

code: Identification (Example Local Codes - Drug#IDT)

QualifiedValues

-Extension
*

Entry 6 - fullUrl = urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "c0f05343-5b98-6073-1a0f-873aaf4f59bc"

url: http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc

title: Assay

status: ACTIVE

code: Assay (Example Local Codes - Drug#ASSAY)

method: Assay by UHPLC ()

QualifiedValues

-Extension
*

Entry 7 - fullUrl = urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"

url: http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f

title: Assay

status: ACTIVE

code: Assay (Example Local Codes - Drug#ASSAY)

QualifiedValues

-Extension
*

Entry 8 - fullUrl = urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "a3d4d23a-800a-684a-6a47-fcfe44e06041"

url: http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041

title: Degradation Products

status: ACTIVE

code: Degradation Products (Example Local Codes - Drug#DGP)

method: Degradation products by UHPLC ()

qualifiedValue

appliesTo: Impurity 1 ()

range: ?-0.2

qualifiedValue

appliesTo: Impurity 2 ()

range: ?-0.3

qualifiedValue

appliesTo: Impurity 3 ()

range: ?-0.3

qualifiedValue

appliesTo: Individual unspecified degradation products ()

range: ?-0.2

qualifiedValue

appliesTo: Total degradation products ()

range: ?-1.4

Components

-Code
*Impurity (Example Local Codes - Drug#IMP)

Entry 9 - fullUrl = urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "ef72eeb7-211a-3c16-8460-8725ca43584f"

url: http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f

title: Degradation Products

status: ACTIVE

code: Degradation Products (Example Local Codes - Drug#DGP)

qualifiedValue

appliesTo: Impurity 1 ()

range: ?-0.8

qualifiedValue

appliesTo: Impurity 2 ()

range: ?-0.4

qualifiedValue

appliesTo: Impurity 3 ()

range: ?-0.4

qualifiedValue

appliesTo: Individual unspecified degradation products ()

range: ?-2.3

qualifiedValue

appliesTo: Total degradation products ()

range: ?-2.3

Components

-Code
*Impurity (Example Local Codes - Drug#IMP)

Entry 10 - fullUrl = urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "bb11322b-9470-4f13-91b5-c8a5253380eb"

url: http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb

title: Dissolution

status: ACTIVE

code: Dissolution (Example Local Codes - Drug#Dissolution)

method: Apparatus 2 (paddles), UV measurement ()

QualifiedValues

-Extension
*

Entry 11 - fullUrl = urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"

url: http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea

title: Dissolution

status: ACTIVE

code: Dissolution (Example Local Codes - Drug#Dissolution)

method: Apparatus 2 (paddles), UV measurement ()

QualifiedValues

-Extension
*

Entry 12 - fullUrl = urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"

url: http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1

title: Water Content

status: ACTIVE

code: Water Content (Example Local Codes - Drug#WaterContent)

method: USP <921> ()

QualifiedValues

-Range
*?-1.0

Entry 13 - fullUrl = urn:uuid:91391017-774b-5c77-93fa-642534278851

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "91391017-774b-5c77-93fa-642534278851"

url: http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851

title: Water Content

status: ACTIVE

code: Water Content (Example Local Codes - Drug#WaterContent)

method: USP <921> ()

QualifiedValues

-Range
*?-2.0

Entry 14 - fullUrl = urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "64972eb3-99ee-7eae-2f63-733e5ae84f71"

url: http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71

title: Microbiological

status: ACTIVE

code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality)

method: Ph Eur ()

QualifiedValues

-Extension
*

Entry 15 - fullUrl = urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "e582e504-36ec-3b50-4043-51bf1147124e"

url: http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e

title: Microbiological

status: ACTIVE

code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality)

method: Ph Eur ()

QualifiedValues

-Extension
*

Entry 16 - fullUrl = urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "e7e2fe59-5433-5cc0-84b1-d5f30032790c"

url: http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c

title: Uniformity of dosage

status: ACTIVE

code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage)

method: Weight variation ()

QualifiedValues

-Extension
*

Entry 17 - fullUrl = urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "43dbc2a3-00c4-6f79-6b11-63768b412aa3"

url: http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3

title: Uniformity of dosage

status: ACTIVE

code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage)

QualifiedValues

-Extension
*

Entry 18 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition

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

description: Textual description of the product

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

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

name

productName: Stelbat Tablets, 20mg

type: Proprietary (Product Name Type - example#Proprietary)

Parts

-PartType
*20mgStrength part (Product Name Part Type#StrengthPart)

Entry 19 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"

status: ACTIVE

for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

role: Active (Ingredient Role#100000072072)

substance

Codes

-Reference
*See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152

Entry 20 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"

manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d

Names

-Name
*Stelbatolol

Entry 21 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d

Resource Organization:

Generated Narrative: Organization

Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

active: true

type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

name: AAA Molybdenum Products, Inc.

Contacts

-Address
*7233 W 116th Pl Ste C Broomfield Colorado 80020 USA