Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
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
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{
"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:5f66b17e-e3c0-4ee4-8106-59faa34d70f7",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "5f66b17e-e3c0-4ee4-8106-59faa34d70f7",
"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_5f66b17e-e3c0-4ee4-8106-59faa34d70f7\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"5f66b17e-e3c0-4ee4-8106-59faa34d70f7\"> </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 "5f66b17e-e3c0-4ee4-8106-59faa34d70f7" </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>: aspirin</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ema-dummy.html\">Dummy EMA Codesystem</a>#1)</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\">Dummy NCIT Codesystem</a>#C134006)</span></p><p><b>manufacturer</b>: <a href=\"#Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">See above (urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5)</a></p><p><b>supplier</b>: <a href=\"#Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">See above (urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)</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>XF417D3PSL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (gsrs.ncats.nih.gov#XF417D3PSL)</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>ASPIRIN</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C203355)</span></td><td>true</td></tr></table></div>"
},
"identifier" : [
{
"value" : "aspirin"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy",
"code" : "1",
"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" : "https://gsrs.ncats.nih.gov",
"code" : "XF417D3PSL"
}
]
}
}
],
"name" : [
{
"name" : "ASPIRIN",
"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></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></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></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#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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