This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
{
"resourceType" : "SubstanceDefinition",
"id" : "496f83ad-2365-4b12-8672-a349d99f7d67",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"496f83ad-2365-4b12-8672-a349d99f7d67\"> </a><a name=\"hc496f83ad-2365-4b12-8672-a349d99f7d67\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "496f83ad-2365-4b12-8672-a349d99f7d67" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-component-substance.html\">Component Substance</a></p></div><p><b>identifier</b>: Grape skin extract</p><p><b>classification</b>: Mixture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C45305)</span></p><p><b>grade</b>: BP <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C176793)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</a></p><p><b>supplier</b>: <a href=\"Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9\">urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>3GOV20705G <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#3GOV20705G)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WINE GRAPE</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>Plant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C14258)</span></td><td>Vitis <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>vinifera <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>skin <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>"
},
"identifier" : [
{
"value" : "Grape skin extract"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C45305",
"display" : "Mixture"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C176793",
"display" : "BP"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
}
],
"supplier" : [
{
"reference" : "urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "3GOV20705G"
}
]
}
}
],
"name" : [
{
"name" : "WINE GRAPE",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C14258",
"display" : "Plant"
}
]
},
"genus" : {
"text" : "Vitis"
},
"species" : {
"text" : "vinifera"
},
"part" : {
"text" : "skin"
},
"countryOfOrigin" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "USA",
"display" : "United States of America"
}
]
}
]
}
}