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
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
Type Value[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
Type Value[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 ()