Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2
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 1.1.2 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
{
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"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"
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"identifier" : {
"extension" : [
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"system" : "urn:ietf:rfc:3986",
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"type" : "document",
"timestamp" : "2024-04-24T01:12:07.108Z",
"entry" : [
{
"fullUrl" : "urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847",
"resource" : {
"resourceType" : "Composition",
"id" : "8a07e353-9cf6-4f27-8a30-2c2d4f439847",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"
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},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><p><b>Generated Narrative: Composition </b><a name=\"8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </a><a name=\"hc8a07e353-9cf6-4f27-8a30-2c2d4f439847\"> </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\">ResourceComposition "8a07e353-9cf6-4f27-8a30-2c2d4f439847" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32p55.html\">eCTD Product Characterisation of Impurities Composition</a></p></div><p><b>status</b>: final</p><p><b>type</b>: Product Characterisation of Impurities <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>#32P55)</span></p><p><b>date</b>: 2024-04-24 01:12:07+0000</p><p><b>author</b>: See on this page: urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788</p><p><b>title</b>: eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll</p></div>"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
"code" : "32P55",
"display" : "Product Characterisation of Impurities"
}
]
},
"date" : "2024-04-24T01:12:07.108Z",
"author" : [
{
"reference" : "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"
}
],
"title" : "eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll",
"section" : [
{
"title" : "Impurities for TabletCoatedBeadsCoatedAll",
"entry" : [
{
"reference" : "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "ddd3abad-347c-4d2f-95f3-dd804e250502",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><p><b>Generated Narrative: MedicinalProductDefinition </b><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </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\">ResourceMedicinalProductDefinition "ddd3abad-347c-4d2f-95f3-dd804e250502" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-with-impurities.html\">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: A drug product composed of one type of bead with two coatings inside a coated tablet</p><p><b>combinedPharmaceuticalDoseForm</b>: TABLET, MULTILAYER <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C42964)</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d</td></tr><tr><td style=\"display: none\">*</td><td>See on this page: urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989</td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: Non-Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-product-name-types.html\">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: LEVOTHYROXINE SODIUM ANHYDROUS <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>"
},
"identifier" : [
{
"value" : "TabletCoatedBeadsCoatedAll"
}
],
"description" : "A drug product composed of one type of bead with two coatings inside a coated tablet",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C42964",
"display" : "TABLET, MULTILAYER"
}
]
},
"impurity" : [
{
"reference" : {
"reference" : "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"
}
},
{
"reference" : {
"reference" : "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"
}
}
],
"name" : [
{
"productName" : "LEVOTHYROXINE SODIUM ANHYDROUS 125mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
"code" : "NON",
"display" : "Non-Proprietary"
}
],
"text" : "Non-Proprietary"
},
"part" : [
{
"part" : "LEVOTHYROXINE SODIUM ANHYDROUS",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "125mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
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],
"text" : "LEVOTHYROXINE SODIUM ANHYDROUS"
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788",
"resource" : {
"resourceType" : "Organization",
"id" : "98effc99-db2b-428d-89aa-0ce426e02788",
"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_98effc99-db2b-428d-89aa-0ce426e02788\"> </a><p><b>Generated Narrative: Organization </b><a name=\"98effc99-db2b-428d-89aa-0ce426e02788\"> </a><a name=\"hc98effc99-db2b-428d-89aa-0ce426e02788\"> </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\">ResourceOrganization "98effc99-db2b-428d-89aa-0ce426e02788" </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>: connectathon_Site</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>connectathon_Site, Restful Rd, Danbury, CT, 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"
}
],
"name" : "connectathon_Site",
"contact" : [
{
"address" : {
"text" : "connectathon_Site, Restful Rd, Danbury, CT, USA",
"line" : [
"Restful Rd"
],
"city" : "Danbury",
"state" : "CT",
"postalCode" : "06811",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "58ae52aa-c81e-415a-8791-e67a3195290d",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><p><b>Generated Narrative: SubstanceDefinition </b><a name=\"58ae52aa-c81e-415a-8791-e67a3195290d\"> </a><a name=\"hc58ae52aa-c81e-415a-8791-e67a3195290d\"> </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\">ResourceSubstanceDefinition "58ae52aa-c81e-415a-8791-e67a3195290d" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: DCM</p><p><b>classification</b>: Residual Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C176815)</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: Leftover Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: ClCCl</p></blockquote></blockquote><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>588X2YUY0A <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>#588X2YUY0A)</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>DICHLOROMETHANE</td><td>Generic Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C97054)</span></td><td>true</td></tr></table></div>"
},
"identifier" : [
{
"value" : "DCM"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C176815",
"display" : "Residual Solvent"
}
]
}
],
"structure" : {
"technique" : [
{
"text" : "Leftover Solvent"
}
],
"representation" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54683",
"display" : "InChI File (small molecule)"
}
]
},
"representation" : "YMWUJEATGCHHMB-UHFFFAOYSA-N"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54684",
"display" : "SMILES"
}
]
},
"representation" : "ClCCl"
}
]
},
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "588X2YUY0A"
}
]
}
}
],
"name" : [
{
"name" : "DICHLOROMETHANE",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C97054",
"display" : "Generic Name"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "ffa30c0b-8031-436a-87f1-635b3bbe5989",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><p><b>Generated Narrative: SubstanceDefinition </b><a name=\"ffa30c0b-8031-436a-87f1-635b3bbe5989\"> </a><a name=\"hcffa30c0b-8031-436a-87f1-635b3bbe5989\"> </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\">ResourceSubstanceDefinition "ffa30c0b-8031-436a-87f1-635b3bbe5989" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-substance-impurity.html\">Drug Substance Impurity</a></p></div><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: Degradation Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C176816)</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: formed from dicalcium phosphate degradation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</p></blockquote></blockquote><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>91D9GV0Z28 <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>#91D9GV0Z28)</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>TRIBASIC CALCIUM PHOSPHATE</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" : "hydroxyApatite"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C176816",
"display" : "Degradation Product"
}
]
}
],
"structure" : {
"technique" : [
{
"text" : "formed from dicalcium phosphate degradation"
}
],
"representation" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54683",
"display" : "InChI File (small molecule)"
}
]
},
"representation" : "XZFUZCHOJLQYHV-UHFFFAOYSA-M"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54684",
"display" : "SMILES"
}
]
},
"representation" : "[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"
}
]
},
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "91D9GV0Z28"
}
]
}
}
],
"name" : [
{
"name" : "TRIBASIC CALCIUM PHOSPHATE",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.2 based on FHIR 5.0.0. Generated 2024-06-24
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