Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
| Active as of 2022-12-08 |
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
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"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </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\">Resource PlanDefinition "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-quality-specification.html\">Quality Specification</a></p></div><p><b>Specification Type</b>: Drug Substance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134022)</span></p><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</code></p><p><b>identifier</b>: ExampleSpecification2</p><p><b>version</b>: 0.1.20</p><p><b>title</b>: Quality Specification for an API</p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-5f66b17e-e3c0-4ee4-8106-59faa34d70f7\">urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7</a></p><p><b>date</b>: 2022-12-08</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International / Biomedical Research and Regulation: <a href=\"http://www.hl7.org/Special/committees/rcrim\">http://www.hl7.org/Special/committees/rcrim</a>,<a href=\"mailto:brr@lists.HL7.org\">brr@lists.HL7.org</a></p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Workflow Setting (Details: http://terminology.hl7.org/CodeSystem/usage-context-type code workflow = 'Workflow Setting', stated as 'Workflow Setting')</td><td>Tentatively Approved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134010)</span></td></tr></table><p><b>jurisdiction</b>: United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#US)</span></p><p><b>approvalDate</b>: 2022-12-08</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b304ed45-5295-4082-9827-f20e1ff0d1d3</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>d4e38c52-30f6-4bb7-ab84-99439a7266ce</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</blockquote><p><b>description</b>: Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Negative <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c0ed4a79-8f40-4d26-8845-4cea166fb627</blockquote><p><b>description</b>: NMT 10 colony-forming units <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>10 colony forming units<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</blockquote><p><b>description</b>: NMT 100 colony-forming units <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>addresses</b>: Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134029)</span>, Stability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134030)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>100 colony forming units<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>title</b>: Microbiological Examination of Nonsterile Products</p><p><b>code</b>: Visual <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Microbial Limits <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-test-category-codes.html\">Hierarchical Test Category Codes</a>#TC13)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style=\"display: none\">*</td><td>documentation</td><td>USP <61></td></tr></table><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LinkId</b></td><td><b>Prefix</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 1</td><td>Staphylococcus aureus</td><td>b304ed45-5295-4082-9827-f20e1ff0d1d3</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 2</td><td>Pseudomonas aeruginosa</td><td>d4e38c52-30f6-4bb7-ab84-99439a7266ce</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 3</td><td>Bacillus subtilis</td><td>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 4</td><td>Total Aerobic Microbial Count (TAMC)</td><td>c0ed4a79-8f40-4d26-8845-4cea166fb627</td></tr><tr><td style=\"display: none\">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 5</td><td>Total Yeasts and Molds Count (TYMC)</td><td>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</td></tr></table></blockquote></div>"
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"reference" : "urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7"
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"useContext" : [
{
"code" : {
"system" : "http://terminology.hl7.org/CodeSystem/usage-context-type",
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"display" : "Workflow Setting"
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"jurisdiction" : [
{
"coding" : [
{
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"code" : "US",
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"approvalDate" : "2022-12-08",
"goal" : [
{
"id" : "b304ed45-5295-4082-9827-f20e1ff0d1d3",
"description" : {
"text" : "Negative"
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"detailCodeableConcept" : {
"coding" : [
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"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C48793",
"display" : "EQ"
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"text" : "Negative"
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{
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"description" : {
"text" : "Negative"
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"detailCodeableConcept" : {
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{
"id" : "2abf1f19-e1b1-42e4-b943-79f5fa1642fe",
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"text" : "Negative"
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{
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"detailCodeableConcept" : {
"coding" : [
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{
"id" : "c0ed4a79-8f40-4d26-8845-4cea166fb627",
"description" : {
"text" : "NMT 10 colony-forming units"
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"addresses" : [
{
"coding" : [
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"extension" : [
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"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
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"coding" : [
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"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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"value" : 10,
"unit" : "colony forming units",
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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{
"id" : "442983b5-bbc3-4534-9f1b-5ae5e4c531c1",
"description" : {
"text" : "NMT 100 colony-forming units"
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"addresses" : [
{
"coding" : [
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"extension" : [
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"value" : 100,
"unit" : "colony forming units",
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{
"id" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 1
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],
"title" : "Microbiological Examination of Nonsterile Products",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C96102",
"display" : "Compendial"
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],
"text" : "Visual"
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"reason" : [
{
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{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
"valueInteger" : 1
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"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
"code" : "TC13",
"display" : "Microbial Limits"
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]
}
],
"documentation" : [
{
"type" : "documentation",
"label" : "USP <61>"
}
],
"action" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 1
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],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 1",
"title" : "Staphylococcus aureus",
"goalId" : [
"b304ed45-5295-4082-9827-f20e1ff0d1d3"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 2
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],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 2",
"title" : "Pseudomonas aeruginosa",
"goalId" : [
"d4e38c52-30f6-4bb7-ab84-99439a7266ce"
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},
{
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"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 3",
"title" : "Bacillus subtilis",
"goalId" : [
"2abf1f19-e1b1-42e4-b943-79f5fa1642fe"
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},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 4
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],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 4",
"title" : "Total Aerobic Microbial Count (TAMC)",
"goalId" : [
"c0ed4a79-8f40-4d26-8845-4cea166fb627"
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},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
"valueDecimal" : 5
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],
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 5",
"title" : "Total Yeasts and Molds Count (TYMC)",
"goalId" : [
"442983b5-bbc3-4534-9f1b-5ae5e4c531c1"
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}
]
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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