Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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 2.0.0-ballot 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
| Active as of 2024-12-04 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="pqcmc-container-type-terminology"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-container-type-terminology</b></p><a name="pqcmc-container-type-terminology"> </a><a name="hcpqcmc-container-type-terminology"> </a><a name="pqcmc-container-type-terminology-en-US"> </a><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C43165</td><td>AMPULE</td></tr><tr><td>C43166</td><td>APPLICATOR</td></tr><tr><td>C43167</td><td>BAG</td></tr><tr><td>C43168</td><td>BLISTER PACK</td></tr><tr><td>C43169</td><td>BOTTLE</td></tr><tr><td>C43170</td><td>BOTTLE, DISPENSING</td></tr><tr><td>C43171</td><td>BOTTLE, DROPPER</td></tr><tr><td>C43172</td><td>BOTTLE, GLASS</td></tr><tr><td>C43173</td><td>BOTTLE, PLASTIC</td></tr><tr><td>C43174</td><td>BOTTLE, PUMP</td></tr><tr><td>C43175</td><td>BOTTLE, SPRAY</td></tr><tr><td>C43176</td><td>BOTTLE, UNIT-DOSE</td></tr><tr><td>C43177</td><td>BOTTLE, WITH APPLICATOR</td></tr><tr><td>C43178</td><td>BOX</td></tr><tr><td>C43179</td><td>BOX, UNIT-DOSE</td></tr><tr><td>C43180</td><td>CAN</td></tr><tr><td>C43181</td><td>CANISTER</td></tr><tr><td>C96143</td><td>Canisters, lined</td></tr><tr><td>C92708</td><td>CAPSULE</td></tr><tr><td>C43182</td><td>CARTON</td></tr><tr><td>C43183</td><td>CARTRIDGE</td></tr><tr><td>C43184</td><td>CASE</td></tr><tr><td>C43185</td><td>CELLO PACK</td></tr><tr><td>C43186</td><td>CONTAINER</td></tr><tr><td>C43187</td><td>CUP</td></tr><tr><td>C43188</td><td>CUP, UNIT-DOSE</td></tr><tr><td>C43189</td><td>CYLINDER</td></tr><tr><td>C43190</td><td>DEWAR</td></tr><tr><td>C43191</td><td>DIALPACK</td></tr><tr><td>C96141</td><td>Dish, Petri</td></tr><tr><td>C43192</td><td>DOSE PACK</td></tr><tr><td>C43193</td><td>DRUM</td></tr><tr><td>C96144</td><td>Flask</td></tr><tr><td>C79135</td><td>FLEXIBLE INTERMEDIATE BULK CONTAINER</td></tr><tr><td>C16738</td><td>INHALER</td></tr><tr><td>C43194</td><td>INHALER, REFILL</td></tr><tr><td>C43195</td><td>JAR</td></tr><tr><td>C43196</td><td>JUG</td></tr><tr><td>C43197</td><td>KIT</td></tr><tr><td>C48626</td><td>NOT STATED</td></tr><tr><td>C43233</td><td>PACKAGE</td></tr><tr><td>C43198</td><td>PACKAGE, COMBINATION</td></tr><tr><td>C43199</td><td>PACKET</td></tr><tr><td>C79136</td><td>PAIL</td></tr><tr><td>C82332</td><td>PATCH</td></tr><tr><td>C96142</td><td>Plate, Microwell</td></tr><tr><td>C43200</td><td>POUCH</td></tr><tr><td>C43201</td><td>SUPERSACK</td></tr><tr><td>C43202</td><td>SYRINGE</td></tr><tr><td>C43203</td><td>SYRINGE, GLASS</td></tr><tr><td>C43204</td><td>SYRINGE, PLASTIC</td></tr><tr><td>C43205</td><td>TABMINDER</td></tr><tr><td>C43206</td><td>TANK</td></tr><tr><td>C53438</td><td>TRAY</td></tr><tr><td>C42794</td><td>TUBE</td></tr><tr><td>C43207</td><td>TUBE, WITH APPLICATOR</td></tr><tr><td>C43226</td><td>VIAL</td></tr><tr><td>C43208</td><td>VIAL, DISPENSING</td></tr><tr><td>C43209</td><td>VIAL, GLASS</td></tr><tr><td>C43210</td><td>VIAL, MULTI-DOSE</td></tr><tr><td>C43211</td><td>VIAL, PATENT DELIVERY SYSTEM</td></tr><tr><td>C43212</td><td>VIAL, PHARMACY BULK PACKAGE</td></tr><tr><td>C43213</td><td>VIAL, PIGGYBACK</td></tr><tr><td>C43214</td><td>VIAL, PLASTIC</td></tr><tr><td>C43215</td><td>VIAL, SINGLE-DOSE</td></tr><tr><td>C43216</td><td>VIAL, SINGLE-USE</td></tr></table></li></ul></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.9"/>
</identifier>
<version value="2.0.0-ballot"/>
<name value="PqcmcContainerTypeTerminology"/>
<title value="Container Type Terminology"/>
<status value="active"/>
<experimental value="false"/>
<date value="2024-12-04T20:50:29+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<compose>
<include>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<concept>
<code value="C43165"/>
<display value="AMPULE"/>
</concept>
<concept>
<code value="C43166"/>
<display value="APPLICATOR"/>
</concept>
<concept>
<code value="C43167"/>
<display value="BAG"/>
</concept>
<concept>
<code value="C43168"/>
<display value="BLISTER PACK"/>
</concept>
<concept>
<code value="C43169"/>
<display value="BOTTLE"/>
</concept>
<concept>
<code value="C43170"/>
<display value="BOTTLE, DISPENSING"/>
</concept>
<concept>
<code value="C43171"/>
<display value="BOTTLE, DROPPER"/>
</concept>
<concept>
<code value="C43172"/>
<display value="BOTTLE, GLASS"/>
</concept>
<concept>
<code value="C43173"/>
<display value="BOTTLE, PLASTIC"/>
</concept>
<concept>
<code value="C43174"/>
<display value="BOTTLE, PUMP"/>
</concept>
<concept>
<code value="C43175"/>
<display value="BOTTLE, SPRAY"/>
</concept>
<concept>
<code value="C43176"/>
<display value="BOTTLE, UNIT-DOSE"/>
</concept>
<concept>
<code value="C43177"/>
<display value="BOTTLE, WITH APPLICATOR"/>
</concept>
<concept>
<code value="C43178"/>
<display value="BOX"/>
</concept>
<concept>
<code value="C43179"/>
<display value="BOX, UNIT-DOSE"/>
</concept>
<concept>
<code value="C43180"/>
<display value="CAN"/>
</concept>
<concept>
<code value="C43181"/>
<display value="CANISTER"/>
</concept>
<concept>
<code value="C96143"/>
<display value="Canisters, lined"/>
</concept>
<concept>
<code value="C92708"/>
<display value="CAPSULE"/>
</concept>
<concept>
<code value="C43182"/>
<display value="CARTON"/>
</concept>
<concept>
<code value="C43183"/>
<display value="CARTRIDGE"/>
</concept>
<concept>
<code value="C43184"/>
<display value="CASE"/>
</concept>
<concept>
<code value="C43185"/>
<display value="CELLO PACK"/>
</concept>
<concept>
<code value="C43186"/>
<display value="CONTAINER"/>
</concept>
<concept>
<code value="C43187"/>
<display value="CUP"/>
</concept>
<concept>
<code value="C43188"/>
<display value="CUP, UNIT-DOSE"/>
</concept>
<concept>
<code value="C43189"/>
<display value="CYLINDER"/>
</concept>
<concept>
<code value="C43190"/>
<display value="DEWAR"/>
</concept>
<concept>
<code value="C43191"/>
<display value="DIALPACK"/>
</concept>
<concept>
<code value="C96141"/>
<display value="Dish, Petri"/>
</concept>
<concept>
<code value="C43192"/>
<display value="DOSE PACK"/>
</concept>
<concept>
<code value="C43193"/>
<display value="DRUM"/>
</concept>
<concept>
<code value="C96144"/>
<display value="Flask"/>
</concept>
<concept>
<code value="C79135"/>
<display value="FLEXIBLE INTERMEDIATE BULK CONTAINER"/>
</concept>
<concept>
<code value="C16738"/>
<display value="INHALER"/>
</concept>
<concept>
<code value="C43194"/>
<display value="INHALER, REFILL"/>
</concept>
<concept>
<code value="C43195"/>
<display value="JAR"/>
</concept>
<concept>
<code value="C43196"/>
<display value="JUG"/>
</concept>
<concept>
<code value="C43197"/>
<display value="KIT"/>
</concept>
<concept>
<code value="C48626"/>
<display value="NOT STATED"/>
</concept>
<concept>
<code value="C43233"/>
<display value="PACKAGE"/>
</concept>
<concept>
<code value="C43198"/>
<display value="PACKAGE, COMBINATION"/>
</concept>
<concept>
<code value="C43199"/>
<display value="PACKET"/>
</concept>
<concept>
<code value="C79136"/>
<display value="PAIL"/>
</concept>
<concept>
<code value="C82332"/>
<display value="PATCH"/>
</concept>
<concept>
<code value="C96142"/>
<display value="Plate, Microwell"/>
</concept>
<concept>
<code value="C43200"/>
<display value="POUCH"/>
</concept>
<concept>
<code value="C43201"/>
<display value="SUPERSACK"/>
</concept>
<concept>
<code value="C43202"/>
<display value="SYRINGE"/>
</concept>
<concept>
<code value="C43203"/>
<display value="SYRINGE, GLASS"/>
</concept>
<concept>
<code value="C43204"/>
<display value="SYRINGE, PLASTIC"/>
</concept>
<concept>
<code value="C43205"/>
<display value="TABMINDER"/>
</concept>
<concept>
<code value="C43206"/>
<display value="TANK"/>
</concept>
<concept>
<code value="C53438"/>
<display value="TRAY"/>
</concept>
<concept>
<code value="C42794"/>
<display value="TUBE"/>
</concept>
<concept>
<code value="C43207"/>
<display value="TUBE, WITH APPLICATOR"/>
</concept>
<concept>
<code value="C43226"/>
<display value="VIAL"/>
</concept>
<concept>
<code value="C43208"/>
<display value="VIAL, DISPENSING"/>
</concept>
<concept>
<code value="C43209"/>
<display value="VIAL, GLASS"/>
</concept>
<concept>
<code value="C43210"/>
<display value="VIAL, MULTI-DOSE"/>
</concept>
<concept>
<code value="C43211"/>
<display value="VIAL, PATENT DELIVERY SYSTEM"/>
</concept>
<concept>
<code value="C43212"/>
<display value="VIAL, PHARMACY BULK PACKAGE"/>
</concept>
<concept>
<code value="C43213"/>
<display value="VIAL, PIGGYBACK"/>
</concept>
<concept>
<code value="C43214"/>
<display value="VIAL, PLASTIC"/>
</concept>
<concept>
<code value="C43215"/>
<display value="VIAL, SINGLE-DOSE"/>
</concept>
<concept>
<code value="C43216"/>
<display value="VIAL, SINGLE-USE"/>
</concept>
</include>
</compose>
</ValueSet>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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