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: bundle-drug-product-specification-pq-ex1

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


Entry 1 - fullUrl = urn:uuid:1f1f1f1f-1f1f-1f1f-1f1f-1f1f1f1f1f1f

Resource MedicinalProductDefinition:

identifier: http://example.org/identifiers/product/PROD-12345

combinedPharmaceuticalDoseForm: Tablet

route: Oral use

Names

-ProductNameType
*Stelbatolol 10mg TabletsInvented Name

Entry 2 - fullUrl = urn:uuid:2f2f2f2f-2f2f-2f2f-2f2f-2f2f2f2f2f2f

Resource Ingredient:

Language: en

Profile: Ingredient - Drug Pq

status: Active

role: Active

substance

Codes

-Reference
*SubstanceDefinition: status = Active

Entry 3 - fullUrl = urn:uuid:3f3f3f3f-3f3f-3f3f-3f3f-3f3f3f3f3f3f

Resource SubstanceDefinition:

status: Active

manufacturer: Organization AAA Molybdenum Products, Inc.

Names

-Name
*Stelbatolol Hydrochloride

Entry 4 - fullUrl = urn:uuid:4f4f4f4f-4f4f-4f4f-4f4f-4f4f4f4f4f4f

Resource PlanDefinition:

Metadata
Title SPECIFICATION(S) FOR DRUG PRODUCT
Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use
Description

Narrative description of specifications

PlanDefinition Action
Title Specification(s) for Drug Product
Code Overall set of actions
PlanDefinition Sub-Action (Parent Action Title: Specification(s) for Drug Product)
Title Release
Code Timing Group
Timing Code
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
PlanDefinition Sub-Action (Parent Action Title: Release)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
PlanDefinition Sub-Action (Parent Action Title: Specification(s) for Drug Product)
Title End of shelf life
Code Timing Group
Timing Code
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
PlanDefinition Sub-Action (Parent Action Title: End of shelf life)
Code Test
Definition http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
Generated using version 0.5.4 of the sample-content-ig Liquid templates

Entry 5 - fullUrl = urn:uuid:5f5f5f5f-5f5f-5f5f-5f5f-5f5f5f5f5f5f

Resource ObservationDefinition:

status: Active

code: Assay

method: Assay by UHPLC


Entry 6 - fullUrl = urn:uuid:6f6f6f6f-6f6f-6f6f-6f6f-6f6f6f6f6f6f

Resource Organization:

Language: en

Profile: Organization - Drug PQ

identifier: FDA Establishment Identifier/3003040516

active: true

type: Drug Substance Manufacture

name: AAA Molybdenum Products, Inc.

Contacts

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