Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-product-manufacturing-pq-ex1",
"meta" : // Product Manufacturing
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "bf6b038b-1334-3dd4-a552-65c169e2265a",
"meta" : // manufacturingProcess-unlinked
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"bf6b038b-1334-3dd4-a552-65c169e2265a\"> </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 "bf6b038b-1334-3dd4-a552-65c169e2265a" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>Extension - Plan Document Reference PQ</b>: <a href=\"#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41feb\">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb)</a></p><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Narrative description of manufacturing process (5)</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pH must be in range 6.9 to 7.1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 200 microns <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#DeviceDefinition_82a39a18-91cf-a29d-76c1-a9e8bad9494d\">See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)</a></td><td>Mixing Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#mixing-vessel)</span></td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#DeviceDefinition_82a39a18-91cf-b29d-76c1-a9e8bad9494d\">See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d)</a></td><td>Receiving Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#receiving-vessel)</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#Capacity)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 750 litres</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Temperature <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#TEMP)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 150 °C<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code Cel = 'Cel')</span></p></blockquote><p><b>prefix</b>: 1</p><p><b>description</b>: Mixing of ingredients</p><p><b>code</b>: Mixing of ingredients <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#Mixing of ingredients)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style=\"display: none\">*</td><td>specification-of</td><td><a href=\"#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee\">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-pH</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href=\"#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494d\">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d)</a></p><p><b>role</b>: Blender <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#Blender)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#StartingMaterial)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: processing material</span></p><p><b>role</b>: Processing Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ProcessingMaterial)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Process temperature must be below 40°C <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#TEMP-MAX "Maximum Temperature")</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 40 °C<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code Cel = 'Cel')</span></p></blockquote><p><b>prefix</b>: 2</p><p><b>description</b>: Drying using a heater</p><p><b>code</b>: Drying <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#drying)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style=\"display: none\">*</td><td>specification-of</td><td><a href=\"#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee\">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-water-content</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href=\"#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bbd9494c\">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c)</a></p><p><b>role</b>: Dryer <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#Dryer)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#StartingMaterial)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Rotational Speed <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#ROTATIONSPEED)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 2500 rpm</p></blockquote><p><b>prefix</b>: 3</p><p><b>description</b>: Particle Size Reduction by using a rotating impeller</p><p><b>code</b>: Particle Size Reduction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#particleSizeReduction)</span></p><h3>Documentations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style=\"display: none\">*</td><td>specification-of</td><td><a href=\"#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee\">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-particle-size</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href=\"#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494c\">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c)</a></p><p><b>role</b>: Compression Milling <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#Compression Milling)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#StartingMaterial)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq",
"valueReference" : {
"reference" : "DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb"
}
},
// Process flow diagram
// or could be a Binary
// DocumentReference/documentreference-drug-pq-process-flow-diagram
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq",
"valueMarkdown" : "This can be text about the history"
}
],
"url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
"title" : "Process 1.0",
"type" : // http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "manufacturing-process",
"display" : "Manufacturing Process"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"description" : "Narrative description of manufacturing process (5)",
"goal" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"id" : "goal-control-pH",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : // this is mandatory, even though we don't really want it
{
"text" : "Controls - pH"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH",
"display" : "pH"
}
],
"text" : "pH must be in range 6.9 to 7.1"
},
"detailRange" : // detailString value="can also be a string"
{
"low" : {
"value" : 6.9,
"unit" : "pH"
},
"high" : {
"value" : 7.1,
"unit" : "pH"
}
}
}
]
},
{
"id" : "goal-control-water-content",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : // this is mandatory, even though we don't really want it
{
"text" : "Controls - Water Content"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water content"
}
],
"text" : "Under 2%"
},
"detailRange" : // detailString value="can also be a string"
{
"high" : {
"value" : 2,
"unit" : "%"
}
}
}
]
},
{
"id" : "goal-control-particle-size",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : {
"text" : "Controls - Particle Size"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "particle-size",
"display" : "Particle Size"
}
],
"text" : "Under 200 microns"
},
"detailRange" : // detailString value="can also be a string"
{
"high" : {
"value" : 200,
"unit" : "microns"
}
}
}
]
}
],
"actor" : [
{
"option" : [
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d"
},
"role" : // DeviceDefinition/mixing-vessel
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "mixing-vessel",
"display" : "Mixing Vessel"
}
]
}
}
]
},
{
"option" : [
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d"
},
"role" : // DeviceDefinition/receiving-tank
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "receiving-vessel",
"display" : "Receiving Vessel"
}
]
}
}
]
}
],
"action" : [
// outer action is the whole thing, if needed
// step 1 mixing
// action>
<code>
<text value="Control"/>
</code>
<definitionCanonical value="ObservationDefinition/ControlPH"/>
</action>
<action>
<code>
<text value="Control"/>
</code>
<definitionCanonical value="ObservationDefinition/ControlTemperature"/>
</action
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq",
"code" : "PROD",
"display" : "Production Scale"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "Capacity",
"display" : "Capacity"
}
]
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 750,
"unit" : "litres"
}
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "TEMP",
"display" : "Temperature"
}
]
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 150,
"unit" : "°C",
"system" : "http://unitsofmeasure.org",
"code" : "Cel"
}
}
]
}
],
"prefix" : "1",
"description" : "Mixing of ingredients",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "Mixing of ingredients",
"display" : "Mixing of ingredients"
}
]
},
"documentation" : [
{
"type" : "specification-of",
"resourceReference" : {
"reference" : "DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"
}
}
],
"goalId" : [
"goal-control-pH"
],
"participant" : [
// DocumentReference/DocumentReference-image
// goalId value="goal-control-temp"/
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d"
},
"role" : // this is new in R5 and is not in R4B
// DeviceDefinition/mixer
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "Blender",
"display" : "Blender"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153"
}
}
],
"display" : "starting material"
},
"role" : // SubstanceDefinition/startingMaterial
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "StartingMaterial",
"display" : "Starting Material"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155"
}
}
],
"display" : "processing material"
},
"role" : // SubstanceDefinition/processingMaterial
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ProcessingMaterial",
"display" : "Processing Material"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821154"
}
}
],
"display" : "resulting material"
},
"role" : // SubstanceDefinition/StelbatololAqueousSolution
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ResultingMaterial",
"display" : "Resulting Material"
}
]
}
}
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq",
"code" : "PROD",
"display" : "Production Scale"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "TEMP-MAX",
"display" : "Maximum Temperature"
}
],
"text" : "Process temperature must be below 40°C"
}
},
// TODO LOINC?
{
"url" : "value",
"valueQuantity" : // todo want a range here
{
"value" : 40,
"unit" : "°C",
"system" : "http://unitsofmeasure.org",
"code" : "Cel"
}
}
]
}
],
"prefix" : "2",
"description" : "Drying using a heater",
"code" : // text value="Step 2 in the process - free text is possible"/
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "drying",
"display" : "Drying"
}
]
},
"documentation" : [
{
"type" : "specification-of",
"resourceReference" : {
"reference" : "DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"
}
}
],
"goalId" : [
"goal-control-water-content"
],
"participant" : [
// DocumentReference/DocumentReference-image
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c"
},
"role" : // this is new in R5 and is not in R4B
// DeviceDefinition/dryer
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "Dryer",
"display" : "Dryer"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821154"
}
}
],
"display" : "starting material"
},
"role" : // SubstanceDefinition/StelbatololAqueousSolution
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "StartingMaterial",
"display" : "Starting Material"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821113"
}
}
],
"display" : "resulting material"
},
"role" : // SubstanceDefinition/StelbatololGranules
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ResultingMaterial",
"display" : "Resulting Material"
}
]
}
}
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq",
"code" : "PROD",
"display" : "Production Scale"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "ROTATIONSPEED",
"display" : "Rotational Speed"
}
]
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 2500,
"unit" : "rpm"
}
}
]
}
],
"prefix" : "3",
"description" : "Particle Size Reduction by using a rotating impeller",
"code" : // text value="Step 2 in the process - free text is possible"/
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "particleSizeReduction",
"display" : "Particle Size Reduction"
}
]
},
"documentation" : [
{
"type" : "specification-of",
"resourceReference" : {
"reference" : "DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"
}
}
],
"goalId" : [
"goal-control-particle-size"
],
"participant" : [
// DocumentReference/DocumentReference-image
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c"
},
"role" : // this is new in R5 and is not in R4B
// DeviceDefinition/devicedefinition-drug-pq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "Compression Milling",
"display" : "Compression Milling"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821113"
}
}
],
"display" : "starting material"
},
"role" : // SubstanceDefinition/StelbatololGranules
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "StartingMaterial",
"display" : "Starting Material"
}
]
}
},
{
"typeReference" : // added to suppress IG warning about empty reference
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"
}
}
],
"display" : "resulting material"
},
"role" : // SubstanceDefinition/Stelbatolol
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ResultingMaterial",
"display" : "Resulting Material"
}
]
}
}
]
}
]
}
},
// step 2 drying
// step 3 particle size
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a19d-76c1-a9e8bad9494c",
"text" : // devicedefinition-drug-pq-ex1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bad9494c\"> </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 DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Rotating Impeller with 1.5mm screen</td><td>registered-name</td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Maximum Speed <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Maximum Speed)</span></td><td>5000 RPM</td></tr></table></div>"
},
"deviceName" : [
// <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq"/>
</meta>
{
"name" : "Rotating Impeller with 1.5mm screen",
"type" : "registered-name"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Maximum Speed",
"display" : "Maximum Speed"
}
]
},
"valueQuantity" : {
"value" : 5000,
"unit" : "RPM"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bbd9494c",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a19d-76c1-a9e8bbd9494c",
"text" : // dryer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bbd9494c\"> </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 DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bbd9494c" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Heated dryer</td><td>registered-name</td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Power <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Power)</span></td><td>3 kW</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Heated dryer",
"type" : "registered-name"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Power",
"display" : "Power"
}
]
},
"valueQuantity" : {
"value" : 3,
"unit" : "kW"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494d",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a19d-76c1-a9e8bad9494d",
"text" : // mixer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bad9494d\"> </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 DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Blender</td><td>registered-name</td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Maximum capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Maximum capacity)</span></td><td>1000 litres</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Blender",
"type" : "registered-name"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Maximum capacity",
"display" : "Maximum capacity"
}
]
},
"valueQuantity" : {
"value" : 1000,
"unit" : "litres"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "74d4c070-6596-8252-8ad9-afa515a41feb",
"text" : // documentreference-drug-pq-process-flow-diagram
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DocumentReference</b><a name=\"74d4c070-6596-8252-8ad9-afa515a41feb\"> </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 DocumentReference "74d4c070-6596-8252-8ad9-afa515a41feb" </p></div><p><b>identifier</b>: id:\u00a0FLOW-001</p><p><b>status</b>: current</p><p><b>type</b>: Process Flow Diagram <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-diagramType-local-pq.html\">CodeSystem - Diagram Type</a>#ProcessFlowDiagram)</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style=\"display: none\">*</td><td>image/x-png</td><td>(base64 data - 8838 bytes)</td></tr></table></blockquote></div>"
},
"identifier" : [
// <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq"/>
</meta>
{
"system" : "http://example.org/fhir/identifier/document",
"value" : "FLOW-001"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-diagramType-local-pq",
"code" : "ProcessFlowDiagram",
"display" : "Process Flow Diagram"
}
]
},
"content" : [
{
"attachment" : {
"contentType" : "image/x-png",
"data" : 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"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fee",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "74d4c070-6596-8252-8ad9-afa515a41fee",
"text" : // DocumentReference-image
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DocumentReference</b><a name=\"74d4c070-6596-8252-8ad9-afa515a41fee\"> </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 DocumentReference "74d4c070-6596-8252-8ad9-afa515a41fee" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Url</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png\">https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png</a></td></tr></table></blockquote></div>"
},
"status" : "current",
"content" : [
{
"attachment" : {
"url" : "https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-dxpq-ex1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </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 MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-local-pq.html\">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
},
"description" : "Textual description of the product",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stelbat Tablets, 20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"text" : // productIngredient
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </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 Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p></div><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152\">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</a></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
],
"role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"
}
}
}
}
},
// SubstanceDefinition/Stelbatolol
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821152",
"text" : // Stelbatolol
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821152\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" </p></div><p><b>manufacturer</b>: <a href=\"#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d\">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821113",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821113",
"meta" : // StelbatololGranules
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821113\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821113" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html\">SubstanceDefinition - Component Substance Drug PQ</a></p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol Granules</td></tr></table></div>"
},
"name" : [
{
"name" : "Stelbatolol Granules"
}
]
}
},
{
"fullUrl" : "urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
"resource" : {
"resourceType" : "Organization",
"id" : "9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"9fe98cfa-9245-8313-0fc5-d15e613b5d6d\"> </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 Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" </p></div><p><b>identifier</b>: id:\u00a03003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</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>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:8d61736c-a6e3-8301-659f-17da402e012a",
"resource" : {
"resourceType" : "Organization",
"id" : "8d61736c-a6e3-8301-659f-17da402e012a",
"text" : // manufacturerProcessingMaterial
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"8d61736c-a6e3-8301-659f-17da402e012a\"> </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 Organization "8d61736c-a6e3-8301-659f-17da402e012a" </p></div><p><b>identifier</b>: id:\u00a03010027650</p><p><b>name</b>: AAA Pharmaceutical, Inc.</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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3010027650"
}
],
"name" : "AAA Pharmaceutical, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"681 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821153",
"text" : // startingMaterial
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821153\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153" </p></div><p><b>manufacturer</b>: <a href=\"#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d\">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatosubstance</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatosubstance"
}
]
}
},
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821154",
"meta" : // StelbatololAqueousSolution
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821154\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html\">SubstanceDefinition - Component Substance Drug PQ</a></p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol Aqueous Solution</td></tr></table></div>"
},
"name" : [
{
"name" : "Stelbatolol Aqueous Solution"
}
]
}
},
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821155",
"text" : // processingMaterial
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821155\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155" </p></div><p><b>manufacturer</b>: <a href=\"#Organization_8d61736c-a6e3-8301-659f-17da402e012a\">See above (Organization/8d61736c-a6e3-8301-659f-17da402e012a)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Processohol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/8d61736c-a6e3-8301-659f-17da402e012a"
}
],
"name" : [
// Organization/manufacturerProcessingMaterial
{
"name" : "Processohol"
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a29d-76c1-a9e8bad9494d",
"text" : // mixing-vessel
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a29d-76c1-a9e8bad9494d\"> </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 DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Mixing Vessel</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Mixing Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceType-local-pq.html\">CodeSystem - Device Type</a>#mixing-vessel)</span></td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Capacity)</span></td><td>1000 litres</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Mixing Vessel",
"type" : "registered-name"
}
],
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq",
"code" : "mixing-vessel",
"display" : "Mixing Vessel"
}
]
}
}
],
"property" : [
{
"type" : {
"coding" : [
// seems a little different to "maximum capacity
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Capacity",
"display" : "Capacity"
}
]
},
"valueQuantity" : {
"value" : 1000,
"unit" : "litres"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-b29d-76c1-a9e8bad9494d",
"text" : // receiving-tank
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-b29d-76c1-a9e8bad9494d\"> </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 DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Receiving Tank</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Receiving Tank <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceType-local-pq.html\">CodeSystem - Device Type</a>#receiving-tank)</span></td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Capacity)</span></td><td>1200 litres</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Receiving Tank",
"type" : "registered-name"
}
],
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq",
"code" : "receiving-tank",
"display" : "Receiving Tank"
}
]
}
}
],
"property" : [
{
"type" : {
"coding" : [
// seems a little different to "maximum capacity
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Capacity",
"display" : "Capacity"
}
]
},
"valueQuantity" : {
"value" : 1200,
"unit" : "litres"
}
}
]
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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