CMCeCTDDocument32P10 bundle - Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC) v0.1.20

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 Bundle: CMCeCTDDocument32P10 bundle

Generated Narrative: Composition

Resource Composition "5dfbbf17-05c0-441d-af66-7a66072f4ae4"

Profile: eCTD Product Description and Composition

status: FINAL

type: Product Description and Composition of the Drug Product (Code System PQCMC Comp Section Types#32P10)

date: 2023-12-09 07:12:23+0000

author: See above (urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a)

title: eCTD Product Description and Composition for Example1Drug

Product Description for Example1Drug

See above (urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc)

Product Composition for Example1Drug

See above (urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149)

Container Closure Description for Example1Drug

See above (urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c)

Additional Document Content

2. urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c (MedicinalProductDefinition/77ad6922-9c59-43d1-93cb-29d063cc2e8c)

Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "77ad6922-9c59-43d1-93cb-29d063cc2e8c"
Profile: Drug Product Container Closure
Container Closure
url
containerType
value: BOTTLE (Dummy NCIT Codesystem#C43169)
url
closureType
value: Child-resistant, Plastic (Dummy NCIT Codesystem#C96114)
url
description
value: a plastic bottle with a child-proof cap
name
productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg
type: Non-Proprietary (Product Name Types Code Types#NON)
part
part: ASPIRIN
type: scientific name (EntityNamePartQualifierR2#SCI)
part
part: 200mg
type: strength name (EntityNamePartQualifierR2#STR)
part
part: ACETAMINOPHEN
type: scientific name (EntityNamePartQualifierR2#SCI)
part
part: 300mg
type: strength name (EntityNamePartQualifierR2#STR)

3. urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc (MedicinalProductDefinition/5772a6f2-cde1-4903-bfcf-1639340205cc)

Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "5772a6f2-cde1-4903-bfcf-1639340205cc"
Profile: Drug Product Description
description: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.
combinedPharmaceuticalDoseForm: TABLET, MULTILAYER (Dummy NCIT Codesystem#C42964)
route: ORAL (Dummy NCIT Codesystem#C38288)
name
productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg
type: Non-Proprietary (Product Name Types Code Types#NON)
part
part: ASPIRIN
type: scientific name (EntityNamePartQualifierR2#SCI)
part
part: 200mg
type: strength name (EntityNamePartQualifierR2#STR)
part
part: ACETAMINOPHEN
type: scientific name (EntityNamePartQualifierR2#SCI)
part
part: 300mg
type: strength name (EntityNamePartQualifierR2#STR)

4. urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149 (ManufacturedItemDefinition/a8316fc9-8ca8-4115-81c1-9f8f84c99149)

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
* See above (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
* See above (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
* See above (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
* See above (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
* See above (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 ()

5. urn:uuid:fc09842a-8f71-48f2-9f9f-ff2441b2eb6f (Ingredient/fc09842a-8f71-48f2-9f9f-ff2441b2eb6f)

Generated Narrative: Ingredient
Resource Ingredient "fc09842a-8f71-48f2-9f9f-ff2441b2eb6f"
Profile: Drug Product Component
status: DRAFT
role: Active Ingredient (Dummy NCIT Codesystem#C82533)
substance
Codes
- Reference
* See above (urn:uuid:2d70d504-8cc6-4282-81d4-b20b0a98b78b)
Strengths
- Extension Presentation[x] TextPresentation
* 200 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]') 200mg

6. urn:uuid:7f10a35e-228d-42db-8918-6ccada78454d (Ingredient/7f10a35e-228d-42db-8918-6ccada78454d)

Generated Narrative: Ingredient
Resource Ingredient "7f10a35e-228d-42db-8918-6ccada78454d"
Profile: Drug Product Component
status: DRAFT
role: Active Ingredient (Dummy NCIT Codesystem#C82533)
substance
Codes
- Reference
* See above (urn:uuid:fc878c4f-a98c-427c-816b-e03ccdf0e712)
Strengths
- Extension Presentation[x] TextPresentation
* 300 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]') 300mg

7. urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2 (Ingredient/d01421cc-6488-468b-a676-d3e7281875e2)

Generated Narrative: Ingredient
Resource Ingredient "d01421cc-6488-468b-a676-d3e7281875e2"
Profile: Drug Product Component
status: DRAFT
role: Inactive Ingredient (Dummy NCIT Codesystem#C42637)
substance
Codes
- Reference
* See above (urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c)
Strengths
- Extension Presentation[x] TextPresentation
* 700 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]') 700mg

8. urn:uuid:3791c4ce-2b43-4d7b-b195-0e5f88f28dab (Ingredient/3791c4ce-2b43-4d7b-b195-0e5f88f28dab)

Generated Narrative: Ingredient
Resource Ingredient "3791c4ce-2b43-4d7b-b195-0e5f88f28dab"
Profile: Drug Product Component
status: DRAFT
role: Inactive Ingredient (Dummy NCIT Codesystem#C42637)
substance
Codes
- Reference
* See above (urn:uuid:496f83ad-2365-4b12-8672-a349d99f7d67)
Strengths
- Extension Presentation[x] TextPresentation
* 1 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]') 1mg

9. urn:uuid:2d70d504-8cc6-4282-81d4-b20b0a98b78b (SubstanceDefinition/2d70d504-8cc6-4282-81d4-b20b0a98b78b)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "2d70d504-8cc6-4282-81d4-b20b0a98b78b"
Profile: Component Substance
identifier: aspirin
classification: Chemical (Dummy EMA Codesystem#1)
grade: USP-NF (Dummy NCIT Codesystem#C134006)
manufacturer: See above (urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579)
supplier: See above (urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9)
Codes
- Code
* R16CO5Y76E (gsrs.ncats.nih.gov#R16CO5Y76E)
Names
- Name Type Preferred
* ASPIRIN GSRS Preferred Term (Dummy NCIT Codesystem#C203355) true
SourceMaterials
- Type
* Chemical (Dummy NCIT Codesystem#C48807)

10. urn:uuid:fc878c4f-a98c-427c-816b-e03ccdf0e712 (SubstanceDefinition/fc878c4f-a98c-427c-816b-e03ccdf0e712)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fc878c4f-a98c-427c-816b-e03ccdf0e712"
Profile: Component Substance
identifier: acetaminophen
classification: Chemical (Dummy EMA Codesystem#1)
grade: USP-NF (Dummy NCIT Codesystem#C134006)
manufacturer: See above (urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579)
supplier: See above (urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9)
Codes
- Code
* 362O9ITL9D (gsrs.ncats.nih.gov#362O9ITL9D)
Names
- Name Type Preferred
* ACETAMINOPHEN GSRS Preferred Term (Dummy NCIT Codesystem#C203355) true
SourceMaterials
- Type
* Chemical (Dummy NCIT Codesystem#C48807)

11. urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c (SubstanceDefinition/393a14e7-3edc-4373-bbe5-9e569d504a1c)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "393a14e7-3edc-4373-bbe5-9e569d504a1c"
Profile: Component Substance
identifier: Maize starch
classification: Mixture (Dummy EMA Codesystem#17)
grade: Company Standard (Dummy NCIT Codesystem#C134009)
manufacturer: See above (urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)
supplier: See above (urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9)
Codes
- Code
* O8232NY3SJ (gsrs.ncats.nih.gov#O8232NY3SJ)
Names
- Name Type Preferred
* STARCH, CORN GSRS Preferred Term (Dummy NCIT Codesystem#C203355) true
SourceMaterials
- Type Genus Species CountryOfOrigin
* Plant (Dummy NCIT Codesystem#C14258) zea () mays () Argentina (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#ARG)

12. urn:uuid:496f83ad-2365-4b12-8672-a349d99f7d67 (SubstanceDefinition/496f83ad-2365-4b12-8672-a349d99f7d67)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "496f83ad-2365-4b12-8672-a349d99f7d67"
Profile: Component Substance
identifier: Grape skin extract
classification: Mixture (Dummy EMA Codesystem#17)
grade: BP (Dummy NCIT Codesystem#C176793)
manufacturer: See above (urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)
supplier: See above (urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9)
Codes
- Code
* 3GOV20705G (gsrs.ncats.nih.gov#3GOV20705G)
Names
- Name Type Preferred
* WINE GRAPE GSRS Preferred Term (Dummy NCIT Codesystem#C203355) true
SourceMaterials
- Type Genus Species Part CountryOfOrigin
* Plant (Dummy NCIT Codesystem#C14258) Vitis () vinifera () skin () United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)

13. urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a (Organization/4f3e9af1-306b-4fad-bf04-7881400b266a)

Generated Narrative: Organization
Resource Organization "4f3e9af1-306b-4fad-bf04-7881400b266a"
Profile: Sponsor Organization
identifier: DUNS/143265222
name: Wunderwerke
Contacts
- Address
* Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478

14. urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9 (Organization/8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9)

Generated Narrative: Organization
Resource Organization "8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9"
Profile: Manufacturing and/or Test Site Organization
identifier: DUNS/123456789, DUNS/1234567
name: Sams BioPharm
Contacts
- Address
* 2752 Main Street Princeton NJ 12345 USA

15. urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579 (Organization/4b565cf3-5353-48af-8cd6-5ccf4e9fd579)

Generated Narrative: Organization
Resource Organization "4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
Profile: Manufacturing and/or Test Site Organization
identifier: DUNS/783452221, FEI/6913973
name: Manufacturing Site (J. Jones Research)
Contacts
- Address
* Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States

16. urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 (Organization/d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)

Generated Narrative: Organization
Resource Organization "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
Profile: Supplier Organization
identifier: DUNS/173265332
name: Mega Chem Supply
Contacts
- Address
* Mega Chem Supply, 350 W Main Street, Rochester, NY, United States