Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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

Compatibility: CMC synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, sections …

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

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Bundle [documentation R4 R5 R6]
id: bundle-drug-product-compatibility-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq
Type: collection
Patient Product Compatibility, on Stelbatolol

Diagnostic Report - Product Compatibility Report [Product Compatibility Report] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq) [documentation R4 R5 R6]
id: processValidationReport
fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd
Date: 2020-12
Status: final
Code: Product Compatibility Report [Product Compatibility Report] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq)
Triggered By: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility
Conclusion: The samples have been assessed and the conclusion is...

Table 2: Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen

PFS Extruded Samples and AI/Pen Extruded Samples
Method / Quality Attribute15°C 25°C 15°C 25°C
SE-UHPLC % Main Peak 8.5 9.5 12.5 13.5
SE-UHPLC % HMW 73.0 79.0 74.0 78.0
CEX-HPLC % Acidic Peak 28.5 28.6 29.5 29.3
CEX-HPLC % Main Peak 18.5 19.5 15.5 16.5

Result
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%) [documentation R4 R5 R6]
id: SE-UHPLCMainPeak1
fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%)
Subject: Lot Number: 88877 (Medication) id: medication-actual-batch-1
Instantiates: SE-UHPLC Main Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: SE-UHPLCMainPeak
Component - SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 8.5%
Component - SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 9.5%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%) [documentation R4 R5 R6]
id: SE-UHPLCMainPeak2
fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%)
Subject: Lot Number: 88878 (Medication) id: medication-actual-batch-2
Instantiates: SE-UHPLC Main Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: SE-UHPLCMainPeak
Component - SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 12.5%
Component - SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 13.5%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%) [documentation R4 R5 R6]
id: SE-UHPLCHMW1
fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%)
Subject: Lot Number: 88877 (Medication) id: medication-actual-batch-1
Instantiates: SE-UHPLC HMW (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: SE-UHPLCHMW
Component - SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 73.0%
Component - SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 79.0%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%) [documentation R4 R5 R6]
id: SE-UHPLCHMW2
fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%)
Subject: Lot Number: 88878 (Medication) id: medication-actual-batch-2
Instantiates: SE-UHPLC HMW (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: SE-UHPLCHMW
Component - SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 74.0%
Component - SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 78.0%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%) [documentation R4 R5 R6]
id: CEX-HPLC-1
fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%)
Subject: Lot Number: 88877 (Medication) id: medication-actual-batch-1
Instantiates: CEX-HPLC Main Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: CEX-HPLCMainPeak
Component - CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 18.5%
Component - CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 19.5%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%) [documentation R4 R5 R6]
id: CEX-HPLC-2
fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%)
Subject: Lot Number: 88878 (Medication) id: medication-actual-batch-2
Instantiates: CEX-HPLC Main Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: CEX-HPLCMainPeak
Component - CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 15.5%
Component - CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Value: 16.5%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%) [documentation R4 R5 R6]
id: CEX-Acidic-1
fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8
Date: 2023-01-01T12:00:00Z
Status: final
Code: CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Subject: Lot Number: 88877 (Medication) id: medication-actual-batch-1
Instantiates: CEX-HPLC Acidic Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: CEX-HPLCAcidicPeak
Component - CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Code: CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Value: 28.5%
Component - CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Code: CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Value: 29.5%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%) [documentation R4 R5 R6]
id: CEX-Acidic-2
fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7
Date: 2023-01-01T12:00:00Z
Status: final
Code: CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Subject: Lot Number: 88877 (Medication) id: medication-actual-batch-1
Instantiates: CEX-HPLC Acidic Peak (%) - Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility (ObservationDefinition) id: CEX-HPLCAcidicPeak
Component - CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Code: CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Value: 28.6%
Component - CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Code: CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Value: 29.3%
Performer
Found a parent (Observation/performer, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/performer, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: 378fbe5f-5926-3a5c-4c64-5428df877b08
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
- Testing Lab
Name: Testing Lab
Report Specification
Found a parent (DiagnosticReport/valueReference, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Plan [documentation R4 R5 R6]
id: plandefinition-compatibility
fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f
url (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
Title: Drug Product Compatibility
Description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Type: Workflow Definition [workflow-definition] (http://terminology.hl7.org/CodeSystem/plan-definition-type), Product Compatibility [product-compatibility] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq)
Status: active
Subject: Stelbatolol (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Action - Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen
Title: Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-compatibility fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Observation Definition - SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%) [documentation R4 R5 R6]
id: SE-UHPLCMainPeak
fullUrl: urn:uuid:64525a3d-5034-448a-9c19-938ce1958424
url (canonical): http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
Title: SE-UHPLC % Main Peak
Status: active
Code: SE-UHPLC Main Peak [SE-UHPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC Main Peak (%)
Component - SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 15 [SE-UHPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Component - SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC Main Peak - 25 [SE-UHPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-compatibility fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Observation Definition - SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%) [documentation R4 R5 R6]
id: SE-UHPLCHMW
fullUrl: urn:uuid:64525a33-5034-448a-9c19-938ce1958424
url (canonical): http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424
Title: SE-UHPLC % HMW
Status: active
Code: SE-UHPLC HMW [SE-UHPLCHMW] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: SE-UHPLC HMW (%)
Component - SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 15 [SE-UHPLCHMW-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Component - SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: SE-UHPLC HMW - 25 [SE-UHPLCHMW-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-compatibility fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Observation Definition - CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%) [documentation R4 R5 R6]
id: CEX-HPLCAcidicPeak
fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e8
url (canonical): http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424
Title: CEX-HPLC % Acidic Peak
Status: active
Code: CEX-HPLC Acidic Peak [CEX-HPLCAcidicPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Acidic Peak (%)
Component - CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Acidic Peak - 15 [CEX-HPLCAcidicPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Component - CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Acidic Peak - 25 [CEX-HPLCAcidicPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: plandefinition-compatibility fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763furl (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Observation Definition - CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%) [documentation R4 R5 R6]
id: CEX-HPLCMainPeak
fullUrl: urn:uuid:74525a3d-5034-448a-9c19-938ce1958424
url (canonical): http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424
Title: CEX-HPLC % Main Peak
Status: active
Code: CEX-HPLC Main Peak [CEX-HPLCMainPeak] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: CEX-HPLC Main Peak (%)
Component - CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 15 [CEX-HPLCMainPeak-15] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Component - CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: CEX-HPLC Main Peak - 25 [CEX-HPLCMainPeak-25] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Triggered: Product Compatibility Report (DiagnosticReport) id: processValidationReport
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stelbatolol
Description: Textual description of the product
Subject of Plan: Drug Product Compatibility (PlanDefinition) id: plandefinition-compatibility
Batch Instance
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Found a parent (Observation/subject, id: SE-UHPLCMainPeak1 fullUrl: urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/subject, id: SE-UHPLCHMW1 fullUrl: urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/subject, id: CEX-HPLC-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Found a parent (Observation/subject, id: CEX-Acidic-1 fullUrl: urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8)
which is linked to this by resource.id
Found a parent (Observation/subject, id: CEX-Acidic-2 fullUrl: urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Medication [documentation R4 R5 R6]
id: medication-actual-batch-1
fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51
- 88877
Definition: Stelbatolol (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Batch
Lot Number: 88877
Manufacturing
Container
Closure System: Pre-filled syringe
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Found a parent (Observation/subject, id: SE-UHPLCMainPeak2 fullUrl: urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/subject, id: SE-UHPLCHMW2 fullUrl: urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7)
which is linked to this by resource.id
Found a parent (Observation/subject, id: CEX-HPLC-2 fullUrl: urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7)
which is linked to this by resource.id
Medication [documentation R4 R5 R6]
id: medication-actual-batch-2
fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc
- 88878
Definition: Stelbatolol (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Batch
Lot Number: 88878
Manufacturing
Container
Closure System: Autoinjector Pen