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 |
{
"resourceType" : "ValueSet",
"id" : "pqcmc-container-type-terminology",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.9"
}
],
"version" : "2.0.0-ballot",
"name" : "PqcmcContainerTypeTerminology",
"title" : "Container Type Terminology",
"status" : "active",
"experimental" : false,
"date" : "2024-12-04T20:50:29+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "brr@lists.HL7.org"
}
]
}
],
"description" : "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" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"compose" : {
"include" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept" : [
{
"code" : "C43165",
"display" : "AMPULE"
},
{
"code" : "C43166",
"display" : "APPLICATOR"
},
{
"code" : "C43167",
"display" : "BAG"
},
{
"code" : "C43168",
"display" : "BLISTER PACK"
},
{
"code" : "C43169",
"display" : "BOTTLE"
},
{
"code" : "C43170",
"display" : "BOTTLE, DISPENSING"
},
{
"code" : "C43171",
"display" : "BOTTLE, DROPPER"
},
{
"code" : "C43172",
"display" : "BOTTLE, GLASS"
},
{
"code" : "C43173",
"display" : "BOTTLE, PLASTIC"
},
{
"code" : "C43174",
"display" : "BOTTLE, PUMP"
},
{
"code" : "C43175",
"display" : "BOTTLE, SPRAY"
},
{
"code" : "C43176",
"display" : "BOTTLE, UNIT-DOSE"
},
{
"code" : "C43177",
"display" : "BOTTLE, WITH APPLICATOR"
},
{
"code" : "C43178",
"display" : "BOX"
},
{
"code" : "C43179",
"display" : "BOX, UNIT-DOSE"
},
{
"code" : "C43180",
"display" : "CAN"
},
{
"code" : "C43181",
"display" : "CANISTER"
},
{
"code" : "C96143",
"display" : "Canisters, lined"
},
{
"code" : "C92708",
"display" : "CAPSULE"
},
{
"code" : "C43182",
"display" : "CARTON"
},
{
"code" : "C43183",
"display" : "CARTRIDGE"
},
{
"code" : "C43184",
"display" : "CASE"
},
{
"code" : "C43185",
"display" : "CELLO PACK"
},
{
"code" : "C43186",
"display" : "CONTAINER"
},
{
"code" : "C43187",
"display" : "CUP"
},
{
"code" : "C43188",
"display" : "CUP, UNIT-DOSE"
},
{
"code" : "C43189",
"display" : "CYLINDER"
},
{
"code" : "C43190",
"display" : "DEWAR"
},
{
"code" : "C43191",
"display" : "DIALPACK"
},
{
"code" : "C96141",
"display" : "Dish, Petri"
},
{
"code" : "C43192",
"display" : "DOSE PACK"
},
{
"code" : "C43193",
"display" : "DRUM"
},
{
"code" : "C96144",
"display" : "Flask"
},
{
"code" : "C79135",
"display" : "FLEXIBLE INTERMEDIATE BULK CONTAINER"
},
{
"code" : "C16738",
"display" : "INHALER"
},
{
"code" : "C43194",
"display" : "INHALER, REFILL"
},
{
"code" : "C43195",
"display" : "JAR"
},
{
"code" : "C43196",
"display" : "JUG"
},
{
"code" : "C43197",
"display" : "KIT"
},
{
"code" : "C48626",
"display" : "NOT STATED"
},
{
"code" : "C43233",
"display" : "PACKAGE"
},
{
"code" : "C43198",
"display" : "PACKAGE, COMBINATION"
},
{
"code" : "C43199",
"display" : "PACKET"
},
{
"code" : "C79136",
"display" : "PAIL"
},
{
"code" : "C82332",
"display" : "PATCH"
},
{
"code" : "C96142",
"display" : "Plate, Microwell"
},
{
"code" : "C43200",
"display" : "POUCH"
},
{
"code" : "C43201",
"display" : "SUPERSACK"
},
{
"code" : "C43202",
"display" : "SYRINGE"
},
{
"code" : "C43203",
"display" : "SYRINGE, GLASS"
},
{
"code" : "C43204",
"display" : "SYRINGE, PLASTIC"
},
{
"code" : "C43205",
"display" : "TABMINDER"
},
{
"code" : "C43206",
"display" : "TANK"
},
{
"code" : "C53438",
"display" : "TRAY"
},
{
"code" : "C42794",
"display" : "TUBE"
},
{
"code" : "C43207",
"display" : "TUBE, WITH APPLICATOR"
},
{
"code" : "C43226",
"display" : "VIAL"
},
{
"code" : "C43208",
"display" : "VIAL, DISPENSING"
},
{
"code" : "C43209",
"display" : "VIAL, GLASS"
},
{
"code" : "C43210",
"display" : "VIAL, MULTI-DOSE"
},
{
"code" : "C43211",
"display" : "VIAL, PATENT DELIVERY SYSTEM"
},
{
"code" : "C43212",
"display" : "VIAL, PHARMACY BULK PACKAGE"
},
{
"code" : "C43213",
"display" : "VIAL, PIGGYBACK"
},
{
"code" : "C43214",
"display" : "VIAL, PLASTIC"
},
{
"code" : "C43215",
"display" : "VIAL, SINGLE-DOSE"
},
{
"code" : "C43216",
"display" : "VIAL, SINGLE-USE"
}
]
}
]
}
}
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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