Example: Bundle – Product Specification - Pharmaceutical Quality (Industry) v1.0.0

Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, 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
- Part Type
* 20mg Strength 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