Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
Active as of 2024-05-08 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="package-grade"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/package-grade</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">in-house<a name="package-grade-in-house"> </a></td><td>in-house</td></tr><tr><td style="white-space:nowrap">NF-PH-Eur<a name="package-grade-NF-PH-Eur"> </a></td><td>NF / Ph Eur</td></tr><tr><td style="white-space:nowrap">BP<a name="package-grade-BP"> </a></td><td>Closure Quality Standard</td></tr><tr><td style="white-space:nowrap">16CFR1700<a name="package-grade-16CFR1700"> </a></td><td>16 CFR 1700</td></tr><tr><td style="white-space:nowrap">21CFR175.300<a name="package-grade-21CFR175.46300"> </a></td><td>21 CFR 175.300</td></tr><tr><td style="white-space:nowrap">EU10-2011<a name="package-grade-EU10-2011"> </a></td><td>European Union Regulation 10/2011</td></tr><tr><td style="white-space:nowrap">EU1935-2004<a name="package-grade-EU1935-2004"> </a></td><td>European Commission Regulation 1935/2004</td></tr><tr><td style="white-space:nowrap">EU78-142<a name="package-grade-EU78-142"> </a></td><td>European Union Council Directive 78/142/EEC</td></tr><tr><td style="white-space:nowrap">EU-94-62-EC<a name="package-grade-EU-94-62-EC"> </a></td><td>EU 94/62/EC</td></tr><tr><td style="white-space:nowrap">PhEur3111<a name="package-grade-PhEur3111"> </a></td><td>Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration</td></tr><tr><td style="white-space:nowrap">PhEur322<a name="package-grade-PhEur322"> </a></td><td>Plastic Containers and Closures for Pharmaceutical Use</td></tr><tr><td style="white-space:nowrap">PhEur<a name="package-grade-PhEur"> </a></td><td>PhEur 3.1.3 Polyolefins</td></tr><tr><td style="white-space:nowrap">USP<a name="package-grade-USP"> </a></td><td>USP <661> Plastic Packaging Systems and Their Materials of Construction</td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url value="http://terminology.hl7.org/CodeSystem/package-grade"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.41.16.22"/>
</identifier>
<version value="1.0.0"/>
<name value="CsPackageGrade"/>
<title value="Package Grade Codes"/>
<status value="active"/>
<experimental value="false"/>
<date value="2024-05-08T12:53:57+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>
</contact>
<description value="This code system contains codes for package grade."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
<text value="World"/>
</jurisdiction>
<caseSensitive value="true"/>
<content value="complete"/>
<concept>
<code value="in-house"/>
<display value="in-house"/>
</concept>
<concept>
<code value="NF-PH-Eur"/>
<display value="NF / Ph Eur"/>
</concept>
<concept>
<code value="BP"/>
<display value="Closure Quality Standard"/>
</concept>
<concept>
<code value="16CFR1700"/>
<display value="16 CFR 1700"/>
</concept>
<concept>
<code value="21CFR175.300"/>
<display value="21 CFR 175.300"/>
</concept>
<concept>
<code value="EU10-2011"/>
<display value="European Union Regulation 10/2011"/>
</concept>
<concept>
<code value="EU1935-2004"/>
<display value="European Commission Regulation 1935/2004"/>
</concept>
<concept>
<code value="EU78-142"/>
<display value="European Union Council Directive 78/142/EEC"/>
</concept>
<concept>
<code value="EU-94-62-EC"/>
<display value="EU 94/62/EC"/>
</concept>
<concept>
<code value="PhEur3111"/>
<display
value="Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration"/>
</concept>
<concept>
<code value="PhEur322"/>
<display value="Plastic Containers and Closures for Pharmaceutical Use"/>
</concept>
<concept>
<code value="PhEur"/>
<display value="PhEur 3.1.3 Polyolefins"/>
</concept>
<concept>
<code value="USP"/>
<display
value="USP <661> Plastic Packaging Systems and Their Materials of Construction"/>
</concept>
</CodeSystem>