Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
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" : "Bundle",
"id" : "6004e36e-7df9-469d-9b29-8e9f9bd7e95f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"
]
},
"identifier" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version",
"valueString" : "0.1.24"
}
],
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65"
},
"type" : "document",
"timestamp" : "2023-12-15T22:36:51.299Z",
"entry" : [
{
"fullUrl" : "urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f",
"resource" : {
"resourceType" : "Composition",
"id" : "55d92f43-e328-4011-bbcf-744e3afd954f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><p><b>Generated Narrative: Composition</b><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"hc55d92f43-e328-4011-bbcf-744e3afd954f\"> </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 Composition "55d92f43-e328-4011-bbcf-744e3afd954f" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification Composition</a></p></div><p><b>identifier</b>: ExampleSpecification2</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-comp-section-types.html\">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2023-12-15 22:36:51+0000</p><p><b>author</b>: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</p><p><b>title</b>: Quality Specification for an API</p></div>"
},
"identifier" : [
{
"value" : "ExampleSpecification2"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
"code" : "SP4151",
"display" : "Quality Specification"
}
]
},
"date" : "2023-12-15T22:36:51.299Z",
"author" : [
{
"reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
}
],
"title" : "Quality Specification for an API",
"section" : [
{
"title" : "32S41",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
"code" : "32S41",
"display" : "Substance Specification"
}
]
},
"entry" : [
{
"reference" : "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </a><a name=\"hccc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </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 PlanDefinition "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-quality-specification.html\">Quality Specification</a></p></div><p><b>Specification Type</b>: Drug Substance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134022)</span></p><p><b>Additional Information</b>: This API is is currently characterized through a standard battery of physicochemical characterzation tests.</p><p><b>identifier</b>: ExampleSpecification2</p><p><b>version</b>: 1.0</p><p><b>title</b>: Quality Specification for an API</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134010 "Tentatively Approved")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</p><p><b>date</b>: 2022-12-08</p><p><b>approvalDate</b>: 2022-12-08</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b304ed45-5295-4082-9827-f20e1ff0d1d3</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>d4e38c52-30f6-4bb7-ab84-99439a7266ce</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c0ed4a79-8f40-4d26-8845-4cea166fb627</blockquote><p><b>description</b>: NMT 10 colony-forming units <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>10 colony forming units<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</blockquote><p><b>description</b>: NMT 100 colony-forming units <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>100 colony forming units<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>title</b>: Microbiological Examination of Nonsterile Products</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Microbial Limits <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC13)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>USP <61></td></tr></table><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LinkId</b></td><td><b>Prefix</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 1</td><td>Staphylococcus aureus</td><td>b304ed45-5295-4082-9827-f20e1ff0d1d3</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 2</td><td>Pseudomonas aeruginosa</td><td>d4e38c52-30f6-4bb7-ab84-99439a7266ce</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 3</td><td>Bacillus subtilis</td><td>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 4</td><td>Total Aerobic Microbial Count (TAMC)</td><td>c0ed4a79-8f40-4d26-8845-4cea166fb627</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 5</td><td>Total Yeasts and Molds Count (TYMC)</td><td>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134022",
"display" : "Drug Substance"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension",
"valueMarkdown" : "This API is is currently characterized through a standard battery of physicochemical characterzation tests."
}
],
"identifier" : [
{
"value" : "ExampleSpecification2"
}
],
"version" : "1.0",
"title" : "Quality Specification for an API",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134010",
"display" : "Tentatively Approved"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"
},
"date" : "2022-12-08",
"approvalDate" : "2022-12-08",
"goal" : [
{
"id" : "b304ed45-5295-4082-9827-f20e1ff0d1d3",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C48793",
"display" : "EQ"
}
],
"text" : "Negative"
}
}
]
},
{
"id" : "d4e38c52-30f6-4bb7-ab84-99439a7266ce",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C48793",
"display" : "EQ"
}
],
"text" : "Negative"
}
}
]
},
{
"id" : "2abf1f19-e1b1-42e4-b943-79f5fa1642fe",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C48793",
"display" : "EQ"
}
],
"text" : "Negative"
}
}
]
},
{
"id" : "c0ed4a79-8f40-4d26-8845-4cea166fb627",
"description" : {
"text" : "NMT 10 colony-forming units"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailQuantity" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C61586",
"display" : "NMT (not more than)"
}
]
}
}
],
"value" : 10,
"unit" : "colony forming units",
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C68742"
}
}
]
},
{
"id" : "442983b5-bbc3-4534-9f1b-5ae5e4c531c1",
"description" : {
"text" : "NMT 100 colony-forming units"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailQuantity" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C61586",
"display" : "NMT (not more than)"
}
]
}
}
],
"value" : 100,
"unit" : "colony forming units",
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C68742"
}
}
]
}
],
"action" : [
{
"id" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 1
}
],
"title" : "Microbiological Examination of Nonsterile Products",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C96102",
"display" : "Compendial"
}
],
"text" : "Visual"
},
"reason" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
"valueInteger" : 1
}
],
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "TC13",
"display" : "Microbial Limits"
}
]
}
],
"documentation" : [
{
"type" : "documentation",
"label" : "USP <61>"
}
],
"action" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 1
}
],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 1",
"title" : "Staphylococcus aureus",
"goalId" : [
"b304ed45-5295-4082-9827-f20e1ff0d1d3"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 2
}
],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 2",
"title" : "Pseudomonas aeruginosa",
"goalId" : [
"d4e38c52-30f6-4bb7-ab84-99439a7266ce"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 3
}
],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 3",
"title" : "Bacillus subtilis",
"goalId" : [
"2abf1f19-e1b1-42e4-b943-79f5fa1642fe"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 4
}
],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 4",
"title" : "Total Aerobic Microbial Count (TAMC)",
"goalId" : [
"c0ed4a79-8f40-4d26-8845-4cea166fb627"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 5
}
],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 5",
"title" : "Total Yeasts and Molds Count (TYMC)",
"goalId" : [
"442983b5-bbc3-4534-9f1b-5ae5e4c531c1"
]
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "580c28ac-1a2c-49fa-9be3-de997da5edcf",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><a name=\"hc580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </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 "580c28ac-1a2c-49fa-9be3-de997da5edcf" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Routine Drug Substance</a></p></div><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: USP-NF <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134006)</span></p><p><b>manufacturer</b>: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</p><p><b>supplier</b>: See on this page: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</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>WK2XYI10QM <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>#WK2XYI10QM)</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>IBUPROFENPIRIN</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></div>"
},
"identifier" : [
{
"value" : "P-Isobutylhydratropic Acid"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
}
],
"supplier" : [
{
"reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "WK2XYI10QM"
}
]
}
}
],
"name" : [
{
"name" : "IBUPROFENPIRIN",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"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-sponsor-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p><b>Generated Narrative: Organization</b><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </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 Organization "4f3e9af1-306b-4fad-bf04-7881400b266a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-sponsor-organization.html\">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Wunderwerke",
"contact" : [
{
"address" : {
"text" : "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
"line" : [
"123 Scenic Road"
],
"city" : "Bridgeport",
"state" : "CT",
"postalCode" : "65478",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"resource" : {
"resourceType" : "Organization",
"id" : "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p><b>Generated Narrative: Organization</b><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </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 Organization "e99bddfa-c1b5-435b-bbe8-24816b4e23e5" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-mfg-test-site-organization.html\">Manufacturing and/or Test Site Organization</a></p></div><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134004",
"display" : "FEI"
}
]
},
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "6981397"
}
],
"name" : "Vidinaid",
"contact" : [
{
"address" : {
"text" : "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
"line" : [
"100 Stillwater Avenue",
"Building #2"
],
"city" : "Bangor",
"state" : "ME",
"postalCode" : "04401",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"resource" : {
"resourceType" : "Organization",
"id" : "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p><b>Generated Narrative: Organization</b><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </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 Organization "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-supplier-organization.html\">Supplier Organization</a></p></div><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "173265332"
}
],
"name" : "Mega Chem Supply",
"contact" : [
{
"address" : {
"text" : "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
"line" : [
"350 W Main Street"
],
"city" : "Rochester",
"state" : "NY",
"postalCode" : "14608",
"country" : "USA"
}
}
]
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change