Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

Example ManufacturedItemDefinition: A FinishedProduct profile based on ManufacturedItemDefinition

Generated Narrative: ManufacturedItemDefinition

Resource ManufacturedItemDefinition "a8316fc9-8ca8-4115-81c1-9f8f84c99149"

Profile: Manufactured Drug Product

identifier: Example1Drug

status: draft

manufacturedDoseForm: Tablet Dosage Form Category (Dummy NCIT Codesystem#C154605)

property

type: Product Overall Release Profile (Dummy NCIT Codesystem#OvrRelsProf)

value: Extended-Release Profile (Dummy NCIT Codesystem#C42713)

property

type: Product Schematic (Dummy NCIT Codesystem#Schematic)

value:

property

type: Product Weight Type (Dummy NCIT Codesystem#WgtTyp)

value: Mass (Dummy NCIT Codesystem#C168628)

property

type: Product Total Weight Numeric Numerator (Dummy NCIT Codesystem#TotWgtNum)

value: 1201 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

property

type: Quality Standard (Dummy NCIT Codesystem#QualStd)

value: USP-NF (Dummy NCIT Codesystem#C134006)

property

type: Product Overall Release Mechanism (Dummy NCIT Codesystem#OvrRelsMech)

value: Matrix (Dummy NCIT Codesystem#C203359)

property

type: Coating Indicator (Dummy NCIT Codesystem#CoatInd)

value: false

property

type: Tablet Layer Count (Dummy NCIT Codesystem#TabLayCnt)

value: 2

property

type: Tablet Bead Type Count (Dummy NCIT Codesystem#BeaTypCnt)

value: 0

property

type: Product Total Weight Numeric Denominator (Dummy NCIT Codesystem#TotWgtDen)

value: 1 1 (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C66832 = '1*')

component

type: Layer (Dummy NCIT Codesystem#C66831)

amount: 463 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

constituent

Content Percent: 0.4319

amount: 200 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

location: Purple Layer (Dummy NCIT Codesystem#C203881 "Active core/granulate")

function: Active Ingredient (Dummy NCIT Codesystem#C82533)

HasIngredients

-Reference
*urn:uuid:fc09842a-8f71-48f2-9f9f-ff2441b2eb6f

constituent

Content Percent: 0.5659

amount: 262 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

location: Purple Layer (Dummy NCIT Codesystem#C203883 "Intragranular")

function: Inactive Ingredient (Dummy NCIT Codesystem#C42637), Filler Excipient (Dummy NCIT Codesystem#C42650)

HasIngredients

-Reference
*urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2

constituent

Content Percent: 0.0022

amount: 1 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

location: Purple Layer (Dummy NCIT Codesystem#C203883 "Intragranular")

function: Inactive Ingredient (Dummy NCIT Codesystem#C42637), Color Excipient (Dummy NCIT Codesystem#C42656)

HasIngredients

-Reference
*urn:uuid:3791c4ce-2b43-4d7b-b195-0e5f88f28dab

Properties

-TypeValue[x]
*Product Part Identifier (Dummy NCIT Codesystem#PPiD)Example1Drug_LayerA ()
*Product Part Release Profile (Dummy NCIT Codesystem#RelsProf)Delayed-Release Profile (Dummy NCIT Codesystem#C42730)
*Product Part Content Percent (Dummy NCIT Codesystem#ContPercent)0.3855
*Product Part Color Description (Dummy NCIT Codesystem#Color)Purple ()

component

type: Layer (Dummy NCIT Codesystem#C66831)

amount: 738 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

constituent

Content Percent: 0.4065

amount: 300 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

location: White Layer (Dummy NCIT Codesystem#C203881 "Active core/granulate")

function: Active Ingredient (Dummy NCIT Codesystem#C82533)

HasIngredients

-Reference
*urn:uuid:7f10a35e-228d-42db-8918-6ccada78454d

constituent

Content Percent: 0.5935

amount: 438 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')

location: White Layer (Dummy NCIT Codesystem#C203883 "Intragranular")

function: Inactive Ingredient (Dummy NCIT Codesystem#C42637), Filler Excipient (Dummy NCIT Codesystem#C42650)

HasIngredients

-Reference
*urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2

Properties

-TypeValue[x]
*Product Part Identifier (Dummy NCIT Codesystem#PPiD)Example1Drug_LayerB ()
*Product Part Release Profile (Dummy NCIT Codesystem#RelsProf)Delayed-Release Profile (Dummy NCIT Codesystem#C42730)
*Product Part Content Percent (Dummy NCIT Codesystem#ContPercent)0.6145
*Product Part Color Description (Dummy NCIT Codesystem#Color)White ()