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
<Bundle xmlns="http://hl7.org/fhir">
<id value="9e8f2d16-66b1-47ec-878d-f50ae021985b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p55"/>
</meta>
<identifier>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version">
<valueString value="1.1.1"/>
</extension>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:2b738e27-de1f-4f63-8d91-c8860089d2a1"/>
</identifier>
<type value="document"/>
<timestamp value="2024-04-24T01:12:07.108Z"/>
<entry>
<fullUrl value="urn:uuid:8a07e353-9cf6-4f27-8a30-2c2d4f439847"/>
<resource>
<Composition>
<id value="8a07e353-9cf6-4f27-8a30-2c2d4f439847"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<status value="final"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
<code value="32P55"/>
<display value="Product Characterisation of Impurities"/>
</coding>
</type>
<date value="2024-04-24T01:12:07.108Z"/>
<author>
<reference value="urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"/>
</author>
<title
value="eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll"/>
<section>
<title value="Impurities for TabletCoatedBeadsCoatedAll"/>
<entry>
<reference value="urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"/>
</entry>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<resource>
<MedicinalProductDefinition>
<id value="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<value value="TabletCoatedBeadsCoatedAll"/>
</identifier>
<description
value="A drug product composed of one type of bead with two coatings inside a coated tablet"/>
<combinedPharmaceuticalDoseForm>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C42964"/>
<display value="TABLET, MULTILAYER"/>
</coding>
</combinedPharmaceuticalDoseForm>
<impurity>
<reference>
<reference value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
</reference>
</impurity>
<impurity>
<reference>
<reference value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
</reference>
</impurity>
<name>
<productName value="LEVOTHYROXINE SODIUM ANHYDROUS 125mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"/>
<code value="NON"/>
<display value="Non-Proprietary"/>
</coding>
<text value="Non-Proprietary"/>
</type>
<part>
<part value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="125mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
<text value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"/>
<resource>
<Organization>
<id value="98effc99-db2b-428d-89aa-0ce426e02788"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="connectathon_Site"/>
<contact>
<address>
<text value="connectathon_Site, Restful Rd, Danbury, CT, USA"/>
<line value="Restful Rd"/>
<city value="Danbury"/>
<state value="CT"/>
<postalCode value="06811"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
<resource>
<SubstanceDefinition>
<id value="58ae52aa-c81e-415a-8791-e67a3195290d"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<value value="DCM"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C176815"/>
<display value="Residual Solvent"/>
</coding>
</classification>
<structure>
<technique>
<text value="Leftover Solvent"/>
</technique>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54683"/>
<display value="InChI File (small molecule)"/>
</coding>
</type>
<representation value="YMWUJEATGCHHMB-UHFFFAOYSA-N"/>
</representation>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</type>
<representation value="ClCCl"/>
</representation>
</structure>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="588X2YUY0A"/>
</coding>
</code>
</code>
<name>
<name value="DICHLOROMETHANE"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C97054"/>
<display value="Generic Name"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
<resource>
<SubstanceDefinition>
<id value="ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<value value="hydroxyApatite"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C176816"/>
<display value="Degradation Product"/>
</coding>
</classification>
<structure>
<technique>
<text value="formed from dicalcium phosphate degradation"/>
</technique>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54683"/>
<display value="InChI File (small molecule)"/>
</coding>
</type>
<representation value="XZFUZCHOJLQYHV-UHFFFAOYSA-M"/>
</representation>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</type>
<representation
value="[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"/>
</representation>
</structure>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="91D9GV0Z28"/>
</coding>
</code>
</code>
<name>
<name value="TRIBASIC CALCIUM PHOSPHATE"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
</Bundle>
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change