Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot 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-ballot 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 above (SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb)

description: Narrative description of specifications

action

title: Specification for Drug Substance

code: Overall set of actions ()

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
*Test ()ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
*Test ()ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
*Test ()ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
*Test ()ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
*Test ()ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
*Test ()ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
*Test ()ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
*Test ()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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - Example Local Codes - Drug#MUT)

method: Impurity 5 content by LC-MS ()

QualifiedValues

-AppliesToRange
*Impurity - Mutagenic ()?-50

Components

-Code
*Impurity (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 (CodeSystem - 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 above (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

name: AAA Molybdenum Products, Inc.

Contacts

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