Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

> > - | 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