{ "resourceType" : "Bundle", "id" : "SpecificationExcipientBundle", "meta" : { "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"] }, "identifier" : { "system" : "urn:ietf:rfc:3986", "value" : "urn:uuid:813b4312-8b6d-42cc-9b8c-8bb6463388cc" }, "type" : "document", "timestamp" : "2024-01-01T19:42:35.255Z", "entry" : [{ "fullUrl" : "urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4", "resource" : { "resourceType" : "Composition", "id" : "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4", "meta" : { "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"] }, "text" : { "status" : "generated", "div" : "

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

Profile: eCTD Specification

identifier: CochinealSpecificationComposition

status: Final

type: m3.2.p.4 control of excipients

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

author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

title: Cochineal specification Composition Example

" }, "identifier" : [{ "value" : "CochinealSpecificationComposition" }], "status" : "final", "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/ICHContextOfUse", "code" : "ich_3.2.p.4", "display" : "m3.2.p.4 control of excipients" }] }, "date" : "2024-01-01T19:42:35.254Z", "author" : [{ "reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" }], "title" : "Cochineal specification Composition Example", "section" : [{ "title" : "32P40", "entry" : [{ "reference" : "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e" }] }] } }, { "fullUrl" : "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e", "resource" : { "resourceType" : "PlanDefinition", "id" : "37bf5cc0-33bf-478b-b84e-ccb35143ef6e", "meta" : { "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"] }, "text" : { "status" : "extensions", "div" : "
\n
\n \n \n \n \n \n \n \n\n \n\n \n \n \n \n \n \n\n \n \n \n \n \n \n\n \n \n \n \n \n \n\n \n\n \n\n \n\n \n \n \n \n \n \n\n \n \n \n \n \n \n \n \n \n\n \n \n \n \n \n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n \n \n \n \n \n
Id: 37bf5cc0-33bf-478b-b84e-ccb35143ef6e
Version: 1.0
\n \n \n \n \n \n \n \n

\n CochinealSpecification\n

\n \n
Title: Cochineal specification Example
Type: \n \n \n \n

\n system: http://terminology.hl7.org/CodeSystem/plan-definition-type\n

\n \n \n

\n code: workflow-definition\n

\n \n \n

\n display: Workflow Definition\n

\n \n \n \n

\n system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl\n

\n \n \n

\n code: C133931\n

\n \n \n

\n display: Raw Materials/Excipients/Intermediates/Reagents\n

\n \n \n \n \n
Subject: \n \n

\n reference: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf\n

\n \n \n \n
Date: 2023-12-01
Actions: \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
\n \n Single Stage Appearance: \n \n
\n \n \n \n \n \n
\n \n Single Stage Identification: \n \n
\n \n \n \n \n \n
\n \n Single Stage pH: \n \n
\n \n \n \n \n \n
\n \n Single Stage Residue on Ignition: \n \n
\n \n \n \n \n \n
\n \n Single Stage Impurities: \n \n
\n \n \n \n Then:\n \n \n \n \n \n \n
\n \n Unidentified Impurities:\n \n \n
\n \n \n \n Then: Additional sub-actions not displayed\n \n
\n \n
\n
\n
\n
" }, "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension", "valueCodeableConcept" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C48660", "display" : "Not Applicable" }] } }], "identifier" : [{ "value" : "CochinealSpecification" }], "version" : "1.0", "title" : "Cochineal specification Example", "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type", "code" : "workflow-definition", "display" : "Workflow Definition" }, { "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C133931", "display" : "Raw Materials/Excipients/Intermediates/Reagents" }] }, "status" : "active", "subjectReference" : { "reference" : "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf" }, "date" : "2023-12-01", "goal" : [{ "id" : "e900181a-876c-4ed6-ac96-d5a73c3d6767", "description" : { "text" : "White Solid" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailString" : "White solid" }] }, { "id" : "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c", "description" : { "text" : "IR spectrum conforms to reference standard" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailString" : "IR spectrum conforms to reference standard" }] }, { "id" : "1f476689-f440-4a77-9e9c-0615af3571eb", "description" : { "text" : "pH 3.4-4.3" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "modifierExtension" : [{ "extension" : [{ "url" : "low", "valueQuantity" : { "value" : 3.4, "comparator" : ">=", "unit" : "[pH]", "system" : "http://unitsofmeasure.org", "code" : "[pH]" } }, { "url" : "high", "valueQuantity" : { "value" : 4.3, "comparator" : "<=", "unit" : "[pH]", "system" : "http://unitsofmeasure.org", "code" : "[pH]" } }], "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range" }] }] }, { "id" : "9c0d2619-4505-4e6b-a801-bc30f84bc3e2", "description" : { "text" : "residue <= 0.21%" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.21, "comparator" : "<=", "unit" : "percent", "system" : "http://unitsofmeasure.org", "code" : "%" } }] }, { "id" : "fc230a97-fd1a-4017-8603-822c5430a217", "description" : { "text" : "Formaldehyde NMT 1.5%" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 1.5, "comparator" : "<=", "unit" : "percent", "system" : "http://unitsofmeasure.org", "code" : "%" } }] }, { "id" : "8d6688e0-7412-4d64-afe8-b73d8aec596e", "description" : { "text" : "Impurity C NMT 2%" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 2, "comparator" : "<=", "unit" : "percent", "system" : "http://unitsofmeasure.org", "code" : "%" } }] }, { "id" : "f8e8343d-a37d-4b91-916b-f58d6947dc9c", "description" : { "text" : "Unspecified Impurity NMT 0.10 % w/w" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.1, "comparator" : "<=", "unit" : "percent WeightToWeight", "system" : "http://unitsofmeasure.org", "code" : "%{WeightToWeight}" } }] }, { "id" : "be7abaa1-0769-4560-af76-326e07d1df9a", "description" : { "text" : "Total Impurities" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.7, "comparator" : "<=", "unit" : "percent", "system" : "http://unitsofmeasure.org", "code" : "%" } }] }, { "id" : "cfdd469d-020b-4047-946f-f513d58f007f", "description" : { "text" : "Total Unidentified Impurities NMT 0.3%" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.3, "comparator" : "<=", "unit" : "percent", "system" : "http://unitsofmeasure.org", "code" : "%" } }] }, { "id" : "c5eea380-416f-4d19-a21e-c021f3c7c543", "description" : { "text" : "RRT 2.2 NMT 0.10% w/w" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.1, "comparator" : "<=", "unit" : "percent WeightToWeight", "system" : "http://unitsofmeasure.org", "code" : "%{WeightToWeight}" } }] }, { "id" : "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c", "description" : { "text" : "RRT 2.4 NMT 0.10% w/w" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.1, "comparator" : "<=", "unit" : "percent WeightToWeight", "system" : "http://unitsofmeasure.org", "code" : "%{WeightToWeight}" } }] }, { "id" : "e493cb3d-45b6-4463-b9b6-e588c51e032c", "description" : { "text" : "RRT 3.41 NMT 0.10% w/w" }, "addresses" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134029", "display" : "Release" }] }, { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134030", "display" : "Stability" }] }], "target" : [{ "detailQuantity" : { "value" : 0.2, "comparator" : "<=", "unit" : "percent WeightToWeight", "system" : "http://unitsofmeasure.org", "code" : "%{WeightToWeight}" } }] }], "action" : [{ "linkId" : "b9359ce8-73f3-45c5-9674-98d850053aa2", "prefix" : "Single Stage", "title" : "Appearance", "code" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96103", "display" : "Proprietary" }], "text" : "Visual" }, "reason" : [{ "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 1 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C205026", "display" : "Organoleptic" }] }, { "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 2 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C138990", "display" : "Description/Appearance" }] }], "documentation" : [{ "type" : "documentation", "label" : "EX-TEST-101" }], "goalId" : ["e900181a-876c-4ed6-ac96-d5a73c3d6767"] }, { "linkId" : "443ed163-7a7b-4d48-9462-be5532158411", "prefix" : "Single Stage", "title" : "Identification", "code" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96103", "display" : "Proprietary" }], "text" : "FTIR" }, "reason" : [{ "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 1 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C138993", "display" : "Identification" }] }], "documentation" : [{ "type" : "documentation", "label" : "EX-TEST-102" }], "goalId" : ["21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c"] }, { "linkId" : "058193ee-dd86-4c63-9f47-7b0608abbca4", "prefix" : "Single Stage", "title" : "pH", "code" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96103", "display" : "Proprietary" }], "text" : "Visual" }, "reason" : [{ "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 1 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C205029", "display" : "pH" }] }], "documentation" : [{ "type" : "documentation", "label" : "EX-TEST-103" }], "goalId" : ["1f476689-f440-4a77-9e9c-0615af3571eb"] }, { "linkId" : "940c8db4-9ed1-416e-84ec-9f9e143be8ab", "prefix" : "Single Stage", "title" : "Residue on Ignition", "code" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96102", "display" : "Compendial" }], "text" : "Visual" }, "reason" : [{ "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 1 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134276", "display" : "Residue on Ignition" }] }], "documentation" : [{ "type" : "documentation", "label" : "USP <281>" }], "goalId" : ["9c0d2619-4505-4e6b-a801-bc30f84bc3e2"] }, { "linkId" : "9fca0a37-6d10-4273-a966-c026ab6eb07d", "prefix" : "Single Stage", "title" : "Impurities", "code" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96103", "display" : "Proprietary" }], "text" : "FTIR" }, "reason" : [{ "extension" : [{ "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension", "valuePositiveInt" : 1 }], "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C204971", "display" : "Impurity" }] }], "documentation" : [{ "type" : "documentation", "label" : "EX-TEST-104" }], "goalId" : ["fc230a97-fd1a-4017-8603-822c5430a217", "8d6688e0-7412-4d64-afe8-b73d8aec596e", "f8e8343d-a37d-4b91-916b-f58d6947dc9c", "be7abaa1-0769-4560-af76-326e07d1df9a", "cfdd469d-020b-4047-946f-f513d58f007f"], "action" : [{ "title" : "Unidentified Impurities", "action" : [{ "prefix" : "RRT", "title" : "2.2", "goalId" : ["c5eea380-416f-4d19-a21e-c021f3c7c543"] }, { "prefix" : "RRT", "title" : "2.4", "goalId" : ["41e19fa2-f568-443e-8bc1-6b0a6dca9d0c"] }, { "prefix" : "RRT", "title" : "3.41", "goalId" : ["e493cb3d-45b6-4463-b9b6-e588c51e032c"] }] }] }] } }, { "fullUrl" : "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf", "resource" : { "resourceType" : "SubstanceDefinition", "id" : "278736ef-2ddf-49e4-895c-3a9f34db36cf", "meta" : { "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"] }, "text" : { "status" : "generated", "div" : "

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

Profile: Excipient Drug Substance

identifier: Cochineal

classification: Chemical

grade: Company Standard

Codes

-Code
*TZ8Z31B35M

Names

-NameTypePreferred
*CochinealGSRS Preferred Termtrue

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*ChemicalDactylopiuscochinealTurkey
" }, "identifier" : [{ "value" : "Cochineal" }], "classification" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C48807", "display" : "Chemical" }] }], "grade" : [{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134009", "display" : "Company Standard" }] }], "code" : [{ "code" : { "coding" : [{ "system" : "http://fdasis.nlm.nih.gov", "code" : "TZ8Z31B35M" }] } }], "name" : [{ "name" : "Cochineal", "type" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C203355", "display" : "GSRS Preferred Term" }] }, "preferred" : true }], "sourceMaterial" : { "type" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C48807", "display" : "Chemical" }] }, "genus" : { "text" : "Dactylopius" }, "species" : { "text" : "cochineal" }, "countryOfOrigin" : [{ "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "TUR", "display" : "Turkey" }] }] } } }, { "fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a", "resource" : { "resourceType" : "Organization", "id" : "4f3e9af1-306b-4fad-bf04-7881400b266a", "meta" : { "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"] }, "text" : { "status" : "generated", "div" : "

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

Profile: Basic Organization

identifier: DUNS/143265222

name: Wunderwerke

Contacts

-Address
*Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
" }, "identifier" : [{ "type" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C134003", "display" : "DUNS" }] }, "system" : "urn:oid:1.3.6.1.4.1.519.1", "value" : "143265222" }], "name" : "Wunderwerke", "contact" : [{ "address" : { "type" : "postal", "text" : "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478", "line" : ["123 Scenic Road"], "city" : "Bridgeport", "state" : "CT", "postalCode" : "65478", "country" : "USA" } }] } }] }