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 – Substance Specification

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

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

Resource PlanDefinition:

> Generated Narrative: PlanDefinition

> Resource PlanDefinition "specificationProtocol"

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

> title: SPECIFICATION FOR DRUG SUBSTANCE

> status: ACTIVE

> subject: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb

> description: Narrative description of specifications

> > action

> > title: Specification for Drug Substance

> > code: Overall set of actions ()

> > ### Actions

> > - | Code | Definition[x]
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
> > * | Test () | http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f

Entry 2 - fullUrl = urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "52176085-1f30-0c67-9ad7-523c486c82c9"

> url: `http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9`

> title: Description

> status: ACTIVE

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

> method: Visual inspection ()

> ### QualifiedValues

> - | Extension
> * |

Entry 3 - fullUrl = urn:uuid:b50d892c-8980-0774-39d4-d449732873a3

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "b50d892c-8980-0774-39d4-d449732873a3"

> url: `http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3`

> title: Identification

> status: ACTIVE

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

> method: Identification by IR spectroscopy Identification by HPLC ()

> ### QualifiedValues

> - | Extension
> * |

Entry 4 - fullUrl = urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "d460b561-110c-7eb6-5d69-788abcca391a"

> url: `http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a`

> title: Assay

> status: ACTIVE

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

> method: Assay by LC ()

> ### QualifiedValues

> - | Range
> * | 98-102 % w/w

Entry 5 - fullUrl = urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "006a9f7b-91ca-5601-38ef-a3dd26ad7121"

> url: `http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121`

> title: Drug Substance Related Organic impurities

> status: ACTIVE

> code: Drug Substance Related Organic impurities (Example Local Codes - Drug#DGP-s)

> method: Organic impurities by LC ()

> > qualifiedValue

> > appliesTo: Impurity 1 ()

> > range: ?-0.5

> > qualifiedValue

> > appliesTo: Impurity 2 ()

> > range: ?-0.5

> > qualifiedValue

> > appliesTo: Any individual unspecified impurity ()

> > range: ?-0.10

> > qualifiedValue

> > appliesTo: Total impurities ()

> > range: ?-2.0

> ### Components

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

Entry 6 - fullUrl = urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "c59deb1b-835c-1be5-4e08-95dea3ae1a17"

> url: `http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17`

> title: Mutagenic impurities

> status: ACTIVE

> code: Mutagenic impurities (Example Local Codes - Drug#MUT)

> method: Impurity 5 content by LC-MS ()

> ### QualifiedValues

> - | AppliesTo | Range
> * | Impurity - Mutagenic () | ?-50

> ### Components

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

Entry 7 - fullUrl = urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "18e20bae-1a24-202d-11d7-5f354c785e4d"

> url: `http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d`

> title: Enantiomeric purity

> status: ACTIVE

> code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity)

> method: Enantiomeric purity by LC ()

> ### QualifiedValues

> - | Range
> * | 99.6-? %

Entry 8 - fullUrl = urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"

> url: `http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce`

> title: Residual solvents

> status: ACTIVE

> code: Residual solvents (Example Local Codes - Drug#SOL)

> method: Residual solvents by headspace GC ()

> > qualifiedValue

> > appliesTo: Solvent 1 ()

> > range: ?-0.1

> > qualifiedValue

> > appliesTo: Solvent 2 ()

> > range: ?-2.0

> ### Components

> - | Code
> * | Solvent (Example Local Codes - Drug#SOLV)

Entry 9 - fullUrl = urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "b4f736ff-1bbf-6923-4d5c-85d262285d7d"

> url: `http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d`

> title: Water Content

> status: ACTIVE

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

> method: USP Karl Fischer titration ()

> ### QualifiedValues

> - | Range
> * | ?-1.0

Entry 10 - fullUrl = urn:uuid:233865df-2a71-528d-756c-85f36bd6685f

Resource ObservationDefinition:

> Generated Narrative: ObservationDefinition

> Resource ObservationDefinition "233865df-2a71-528d-756c-85f36bd6685f"

> url: `http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f`

> title: Particle size distribution

> status: ACTIVE

> code: Particle size distribution (Example Local Codes - Drug#particle-size-distribution)

> method: Laser diffraction ()

> > qualifiedValue

> > appliesTo: D(v,0.9) ()

> > range: ?-319

> > qualifiedValue

> > appliesTo: D(v,0.5) ()

> > range: ?-145

> > qualifiedValue

> > appliesTo: D(v,0.1) ()

> > range: ?-20

> ### Components

> - | Code
> * | Particle size (Example Local Codes - Drug#particle-size)

Entry 11 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-70f9-647b0ea97adb"

> manufacturer: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620

> ### Names

> - | Name
> * | Stelbatolol

Entry 12 - fullUrl = urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "062bf235-44e2-55c4-9213-bbe5e12d5620"

> 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