Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
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 2026-05-10 |
{
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex1-validation-protocol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <table class=\"narrative-table\">\n <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">DP PROCESS VALIDATION</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Version</th>\n\n\n\n<td class=\"content-container\">1.0.0</td>\n\n\n</tr>\n\n\n\n\n\n\n\n \n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Identifier</th>\n\n\n\n<td class=\"content-container\">urn:oid:2.16.840.1.113883.4.642.40.41.34.1</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Subject Type</th>\n\n\n\n<td class=\"content-container\"><a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Jurisdiction</th>\n\n\n\n<td class=\"content-container\">\n World\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward (Publisher)</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward Contact</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Type</th>\n\n\n\n<td class=\"content-container\">\n Workflow Definition\n\n\n Process Validation\n\n\n</td>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Formulation Buffer Preparation Process Parameter Step</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Formulation Buffer Preparation Process Parameter Step\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Formulation Buffer Preparation Process Parameter Step</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">FormulationBufferPreparationProcessParameterStep\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Conclusion\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Formulation Buffer Preparation Performance Indicator Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Formulation Buffer Preparation Performance Indicator Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">???</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">???\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Thawing and Formulation Process Parameter Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Thawing and Formulation Process Parameter Resultss\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">???</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">???\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Thawing and Formulation Performance Indicator Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Thawing and Formulation Performance Indicator Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">???</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">???\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: ???)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Bioburden Reduction Filtration Process Parameter Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Bioburden Reduction Filtration Process Parameter Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Bioburden Reduction Filtration Performance Indicator Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Bioburden Reduction Filtration Performance Indicator Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Media Challenge Hold Times</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Media Challenge Hold Times\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Media Challenge Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Media Challenge Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Filtered Formulated Drug Product Performance Indicator Results</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Filtered Formulated Drug Product Performance Indicator Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Fill Weight Summary</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Fill Weight Summary\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Filling Homogeneity Quality Attributes</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Filling Homogeneity Quality Attributes\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Conclusion\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Filling Results Summary</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Filling Results Summary\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Statistical Evaluation of Homogeneity Data</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Statistical Evaluation of Homogeneity Data\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Consistency of the Lyophilization Process</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Consistency of the Lyophilization Process\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Definition\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Lyophilization Homogeneity</td>\n\n\n</tr>\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">\n Lyophilization Homogeneity Results\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Code</th>\n\n\n\n<td class=\"content-container\">Test\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n\n\n\n\n<tr>\n <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>\n</tr>\n\n </tbody>\n </table>\n</div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.41.34.1"
}
],
"version" : "1.0.0",
"title" : "DP PROCESS VALIDATION",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type",
"code" : "process-validation",
"display" : "Process Validation"
}
]
},
"status" : "active",
"subjectReference" : {
🔗 "reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"date" : "2026-05-10T20:32:51+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"
}
]
}
],
"description" : "Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"action" : [
{
"title" : "Formulation Buffer Preparation Process Parameter Step",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FormulationBufferPreparationProcessParameterStep",
"display" : "Formulation Buffer Preparation Process Parameter Step"
}
],
"text" : "Formulation Buffer Preparation Process Parameter Step"
},
"action" : [
{
"title" : "Formulation Buffer Preparation Process Parameter Step",
"code" : {
"text" : "FormulationBufferPreparationProcessParameterStep"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
}
]
}
]
},
{
"title" : "Formulation Buffer Preparation Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FormulationBufferPreparationPerformanceIndicatorStep",
"display" : "Formulation Buffer Preparation Performance Indicator Results"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"
}
]
}
]
},
{
"title" : "Thawing and Formulation Process Parameter Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ThawingandFormulationProcessParameterResultsStep",
"display" : "Thawing and Formulation Process Parameter Resultss"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"
}
]
}
]
},
{
"title" : "Thawing and Formulation Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ThawingandFormulationPerformanceIndicatorResultsStep",
"display" : "Thawing and Formulation Performance Indicator Results"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"
}
]
}
]
},
{
"title" : "Bioburden Reduction Filtration Process Parameter Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "BioburdenReductionFiltrationProcessParameterResultsStep",
"display" : "Bioburden Reduction Filtration Process Parameter Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Bioburden Reduction Filtration Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "BioburdenReductionFiltrationPerformanceIndicatorResultsStep",
"display" : "Bioburden Reduction Filtration Performance Indicator Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Media Challenge Hold Times",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "MediaChallengeHoldTimesStep",
"display" : "Media Challenge Hold Times"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Media Challenge Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "MediaChallengeResultsStep",
"display" : "Media Challenge Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"
}
]
},
{
"title" : "Filtered Formulated Drug Product Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep",
"display" : "Filtered Formulated Drug Product Performance Indicator Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"
}
]
},
{
"title" : "Fill Weight Summary",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillWeightSummaryStep",
"display" : "Fill Weight Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"
}
]
},
{
"title" : "Filling Homogeneity Quality Attributes",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillingHomogeneityQualityAttributesStep",
"display" : "Filling Homogeneity Quality Attributes"
}
],
"text" : "Filling Homogeneity Quality Attributes"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"
}
]
},
{
"title" : "Filling Results Summary",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillingResultsSummaryStep",
"display" : "Filling Results Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"
}
]
},
{
"title" : "Statistical Evaluation of Homogeneity Data",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "StatisticalEvaluationOfHomogeneityDataStep",
"display" : "Statistical Evaluation of Homogeneity Data"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"
}
]
},
{
"title" : "Consistency of the Lyophilization Process",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ConsistencyoftheLyophilizationProcessStep",
"display" : "Consistency of the Lyophilization Process"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Definition"
},
"definitionCanonical" : "http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"
}
]
},
{
"title" : "Lyophilization Homogeneity",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "LyophilizationHomogeneityStep",
"display" : "Lyophilization Homogeneity Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"
}
]
}
]
}
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change