Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 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-fda/ and changes regularly. See the Directory of published versions

Example Bundle: 7cdbb042-9275-4599-a1fe-08877846bf94

Document Details

Generated Narrative: Bundle Cochineal specification Composition Example


Document Content

32P40


Additional Resources Included in Document


Entry 1 - fullUrl = urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4

Resource Composition:

Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4

identifier: CochinealSpecificationComposition

status: Final

type: Product Control of Excipients

date: 2024-01-01 19:42:35+0000

author: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

title: Cochineal specification Composition Example


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Resource PlanDefinition:

Generated Narrative: PlanDefinition 37bf5cc0-33bf-478b-b84e-ccb35143ef6e

Specification Status: Not Applicable

identifier: CochinealSpecification

version: 1.0

title: Cochineal specification Example

type: Workflow Definition

status: Active

subject: Bundle: identifier = UUID:813b4312-8b6d-42cc-9b8c-8bb6463388cc; type = document; timestamp = 2024-01-01 19:42:35+0000

date: 2023-12-01

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Targets

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Targets

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goal

id

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Targets

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*

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id

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Targets

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goal

id

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Targets

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goal

id

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Targets

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goal

id

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Targets

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goal

id

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Targets

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goal

id

cfdd469d-020b-4047-946f-f513d58f007f

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goal

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goal

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Targets

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goal

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Targets

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action

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Documentations

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action


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Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf

identifier: Cochineal

classification: Chemical

grade: Company Standard

Codes

-Code
*TZ8Z31B35M

Names

-NameTypePreferred
*CochinealGSRS Preferred Termtrue

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*ChemicalDactylopiuscochinealTurkey

Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a

identifier: DUNS/143265222

name: Wunderwerke

Contacts

-Address
*Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478