Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Process Validation: synthetic data rendering - drug substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.2 Manufacture , subsection 3.2.S.2.5 Process Validation and/or Evaluation.

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.

Bundle [documentation R4 R5 R6]
id: bundle-product-process-validation-pq-ex2-sub
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq
Type: collection
Process Validation Report, on Stelbatolol


Table 1. Batches Used in Stelbatolol Drug Substance Process Validation

Date of Manufacture Drug Substance Batch Number Batch Size (kg)
Amgen Batch Number Site A Batch Number
2019-09-07 SUB1Amgen SUB1SiteA 5.1
2019-09-07 SUB2Amgen SUB2SiteA 5.2
2019-09-07 SUB3Amgen SUB3SiteA 5.3


Diagnostic Report - Process Validation Report [Process Validation Report] (http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type) [documentation R4 R5 R6]
id: processValidationReport
fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd
Date: 2020-12
Status: final
Code: Process Validation Report [Process Validation Report] (http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type)
Triggered By: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol
Conclusion: The samples have been assessed and the conclusion is...

Table 2: Step 1 Process Validation Batches

Date of Manufacture Starting Material Batch Number Step 1 Manufacturing Scale (kg of starting material 1) Intermediate Batch Number Intermediate Batch Size (kg)
2019-09-01 Start1Amgen 8.1 Intermed1Amgen 9.1
2019-09-01 Start2Amgen 8.2 Intermed2Amgen 9.2
2019-09-01 Start3Amgen 8.3 Intermed3Amgen 9.3



Table 3: Step 1 Yield

Intermediate Batch Number
Performance IndicatorIntermed1Amgen Intermed2Amgen Intermed3Amgen
Yield (%) 75 77 76


Table 4: Step 1 In-Process Control Data

Intermediate Batch Number
Performance IndicatorAcceptance Criteria ClassificationIntermed1Amgen Intermed2Amgen Intermed3Amgen
Residual Water Content (w/w%) NMT 7.15 % Non-critical 6.9 7.0 6.8
Reaction conversion: residual starting material 1 by HPLC (Step Aa) (LC area %) NMT 23 % Critical


Table 5: Step 1 DS Release Testing Results

DS Batch Number
Performance IndicatorAcceptance Criteria Intermed1Amgen Intermed2Amgen Intermed3Amgen
Appearance White to off-white, to red, to orange, to brown solid Off-white solid Off-white solid Off-white solid
ID by HPLC Conforms to standard Conforms Conforms Does not conform
Assay by HPLC (as is) (w/w%) 95 % - 101 %


Table 6: Step 2 Process Validation Batches

Date of Manufacture Starting Material Batch Number Step 2 Manufacturing Scale (kg of starting material 2) Intermediate Batch Number Intermediate Batch Size (kg)
2019-09-02 Start1Step2Amgen 7.1 Intermed1Step2Amgen 10.1
2019-09-02 Start2Step2Amgen 7.2 Intermed2Step2Amgen 10.2
2019-09-02 Start3Step2Amgen 7.3 Intermed3Step2Amgen 10.3



Table 7: Step 2 Yield

Intermediate 2 Batch Number
Performance IndicatorIntermed1Step2Amgen Intermed2Step2Amgen Intermed3Step2Amgen
Yield (%) 85 87 86

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 - Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance [documentation R4 R5 R6]
id: appearanceSubstance1
fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance
Value: Off-white solid
Subject: Intermed1Amgen (Substance) id: actual-batch-substance-itermediate-1
Instantiates: Appearance - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: AppearanceSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance [documentation R4 R5 R6]
id: appearanceSubstance2
fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance
Value: Off-white solid
Subject: Intermed2Amgen (Substance) id: actual-batch-substance-itermediate-2
Instantiates: Appearance - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: AppearanceSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance [documentation R4 R5 R6]
id: appearanceSubstance3
fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance
Value: Off-white solid
Subject: Intermed3Amgen (Substance) id: actual-batch-substance-itermediate-3
Instantiates: Appearance - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: AppearanceSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC [documentation R4 R5 R6]
id: identificationSubstance1
fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC
Value: Conforms
Subject: Intermed1Amgen (Substance) id: actual-batch-substance-itermediate-1
Instantiates: ID by HPLC - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: IdentificationSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC [documentation R4 R5 R6]
id: identificationSubstance2
fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC
Value: Conforms
Subject: Intermed2Amgen (Substance) id: actual-batch-substance-itermediate-2
Instantiates: ID by HPLC - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: IdentificationSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC [documentation R4 R5 R6]
id: identificationSubstance3
fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC
Value: Does not conform
Subject: Intermed3Amgen (Substance) id: actual-batch-substance-itermediate-3
Instantiates: ID by HPLC - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: IdentificationSubstance
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step1Yield1
fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 75%
Subject: Intermed1Amgen (Substance) id: actual-batch-substance-itermediate-1
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step1Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step1Yield2
fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 77%
Subject: Intermed2Amgen (Substance) id: actual-batch-substance-itermediate-2
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step1Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step1Yield3
fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 76%
Subject: Intermed3Amgen (Substance) id: actual-batch-substance-itermediate-3
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step1Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step2Yield1
fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 85%
Subject: Intermed1Step2Amgen (Substance) id: actual-batch-substance-itermediate-step2-1
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step2Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step2Yield2
fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 87%
Subject: Intermed2Step2Amgen (Substance) id: actual-batch-substance-itermediate-step2-2
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step2Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: step2Yield3
fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Value: 86%
Subject: Intermed3Step2Amgen (Substance) id: actual-batch-substance-itermediate-step2-3
Instantiates: Yield (%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Step2Yield
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%) [documentation R4 R5 R6]
id: residualWaterContent1
fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%)
Value: 6.9%
Subject: Intermed1Amgen (Substance) id: actual-batch-substance-itermediate-1
Instantiates: Residual Water Content (w/w%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: ResidualWaterContent
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%) [documentation R4 R5 R6]
id: residualWaterContent2
fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%)
Value: 7.0%
Subject: Intermed2Amgen (Substance) id: actual-batch-substance-itermediate-2
Instantiates: Residual Water Content (w/w%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: ResidualWaterContent
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (DiagnosticReport/result, id: processValidationReport fullUrl: urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd)
which is linked to this by resource.id
Observation - Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%) [documentation R4 R5 R6]
id: residualWaterContent3
fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33
Date: 2023-01-01T12:00:00Z
Status: final
Code: Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ResidualWaterContent (w/w%)
Value: 6.8%
Subject: Intermed3Amgen (Substance) id: actual-batch-substance-itermediate-3
Instantiates: Residual Water Content (w/w%) - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: ResidualWaterContent
Performer
Found a parent (Observation/performer, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/performer, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
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
Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: Testing Lab
Type: Analytical Testing - Release [analytical-testing-release] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Found a parent (PlanDefinition/subjectReference, id: validationProtocol 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 (Substance/code, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substancedefinition-component-substance-dxpq-ex1
fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substancedefinition-component-substance-dxpq-ex1 fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-dxpq-ex1
fullUrl: urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Subject of Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol
Batch Instance
Substance - SUB1Amgen - SUB1SiteA [documentation R4 R5 R6]
id: substance-dxpq-ex1-unlinked
fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: SUB1Amgen
Identifier: SUB1SiteA
Identifier Assigner
AAA Molybdenum Products, Inc., Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82) (Organization) id: organization-dxpq-ex1
Definition: Stelbatolol (SubstanceDefinition) id: substancedefinition-component-substance-dxpq-ex1
Manufacturing
Date: 2019-09-07
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 5.1 kg
Actual Yield: 4.8 kg
Utilization: Development [C133991] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl)
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substancedefinition-component-substance-dxpq-ex1 fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-dxpq-ex1
fullUrl: urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Substance - SUB2Amgen - SUB2SiteA [documentation R4 R5 R6]
id: actual-batch-substance-2-unlinked
fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad
Instance: true
Identifier: SUB2Amgen
Identifier: SUB2SiteA
Identifier Assigner
AAA Molybdenum Products, Inc., Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82) (Organization) id: organization-dxpq-ex1
Definition: Stelbatolol (SubstanceDefinition) id: substancedefinition-component-substance-dxpq-ex1
Manufacturing
Date: 2019-09-07
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 5.2 kg
Actual Yield: 4.8 kg
Utilization: Development [C133991] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl)
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substancedefinition-component-substance-dxpq-ex1 fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-dxpq-ex1
fullUrl: urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Substance - SUB3Amgen - SUB3SiteA [documentation R4 R5 R6]
id: actual-batch-substance-3-unlinked
fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c
Instance: true
Identifier: SUB3Amgen
Identifier: SUB3SiteA
Identifier Assigner
AAA Molybdenum Products, Inc., Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82) (Organization) id: organization-dxpq-ex1
Definition: Stelbatolol (SubstanceDefinition) id: substancedefinition-component-substance-dxpq-ex1
Manufacturing
Date: 2019-09-07
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 5.3 kg
Actual Yield: 4.8 kg
Utilization: Development [C133991] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl)
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substancedefinition-component-substance-dxpq-ex1 fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: substance-dxpq-ex1-unlinked fullUrl: urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-2-unlinked fullUrl: urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Found a parent (Substance/assigner, id: actual-batch-substance-3-unlinked fullUrl: urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: organization-dxpq-ex1
fullUrl: urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
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: validationProtocol
fullUrl: urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f
url (canonical): http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
Title: DP PROCESS VALIDATION
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), Process Validation [process-validation] (http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type)
Status: active
Subject: Stelbatolol (SubstanceDefinition) id: substancedefinition-component-substance-dxpq-ex1
Action - 1 - Step 1 Yield - Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 1
Title: Step 1 Yield
Code: Particle Size Reduction [particleSizeReduction] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Description of this step
Scale: Production Scale [PROD] (http://terminology.hl7.org/CodeSystem/manufacturing-step-scale)
Parameters
Parameter: Mix speed [SPEED] (http://terminology.hl7.org/CodeSystem/process-parameter)
Value Quantity: 1500 rpm
Participant
Role: Starting Material [StartingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Starting material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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 (Substance/code, id: actual-batch-substance-starting-1 fullUrl: urn:uuid:fc178762-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-starting-2 fullUrl: urn:uuid:fc178762-81d5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-starting-3 fullUrl: urn:uuid:fc178762-81d5-5656-9744-23c7ad1e595b)
which is linked to this by resource.id
Substance - Stelbatosubstance [documentation R4 R5 R6]
id: startingMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153
Name: Stelbatosubstance
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterialStep2 fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterialStep2 fullUrl: urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Batch Instance
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-1 fullUrl: urn:uuid:fc178763-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start1Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-1
fullUrl: urn:uuid:fc178762-81c5-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start1Amgen
Definition: Stelbatosubstance (SubstanceDefinition) id: startingMaterial
Manufacturing
Date: 2019-09-01
Quantity: 8.1 kg
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-2 fullUrl: urn:uuid:fc178764-81d5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-2
fullUrl: urn:uuid:fc178762-81d5-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start2Amgen
Definition: Stelbatosubstance (SubstanceDefinition) id: startingMaterial
Manufacturing
Date: 2019-09-01
Quantity: 8.2 kg
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-3 fullUrl: urn:uuid:fc178764-81d6-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start3Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-3
fullUrl: urn:uuid:fc178762-81d5-5656-9744-23c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start3Amgen
Definition: Stelbatosubstance (SubstanceDefinition) id: startingMaterial
Manufacturing
Date: 2019-09-01
Quantity: 8.3 kg
Participant
Role: Intermediate Material [IntermediateMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Intermediate material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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 (Substance/code, id: actual-batch-substance-itermediate-1 fullUrl: urn:uuid:fc178763-81c5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-itermediate-2 fullUrl: urn:uuid:fc178764-81d5-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-itermediate-3 fullUrl: urn:uuid:fc178764-81d6-5656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - Processohol [documentation R4 R5 R6]
id: intermediateMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155
Name: Processohol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterialStep2 fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterialStep2 fullUrl: urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Batch Instance
Found a parent (Observation/subject, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed1Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-1
fullUrl: urn:uuid:fc178763-81c5-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed1Amgen
Definition: Processohol (SubstanceDefinition) id: intermediateMaterial
Manufacturing
Quantity: 9.1 kg
Derived From: Start1Amgen (Substance) id: actual-batch-substance-starting-1
Found a parent (Observation/subject, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-2
fullUrl: urn:uuid:fc178764-81d5-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed2Amgen
Definition: Processohol (SubstanceDefinition) id: intermediateMaterial
Manufacturing
Quantity: 9.2 kg
Derived From: Start2Amgen (Substance) id: actual-batch-substance-starting-2
Found a parent (Observation/subject, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/subject, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed3Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-3
fullUrl: urn:uuid:fc178764-81d6-5656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed3Amgen
Definition: Processohol (SubstanceDefinition) id: intermediateMaterial
Manufacturing
Quantity: 9.3 kg
Derived From: Start3Amgen (Substance) id: actual-batch-substance-starting-3
Participant
Role: Resulting Material [ResultingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Resulting material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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
Substance - Resultothane [documentation R4 R5 R6]
id: resultingMaterial
fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154
Name: Resultothane
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Found a parent (Observation/instantiatesReference, id: step1Yield1 fullUrl: urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: step1Yield2 fullUrl: urn:uuid:9c56948a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: step1Yield3 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Observation Definition - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: Step1Yield
fullUrl: urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
url (canonical): http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
Title: Yield (%)
Status: active
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Action - Step 1 In-Process Control Data - Step 1 In-Process Control Data [Step1In-ProcessControlData] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Title: Step 1 In-Process Control Data
Code: Step 1 In-Process Control Data [Step1In-ProcessControlData] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Found a parent (Observation/instantiatesReference, id: residualWaterContent1 fullUrl: urn:uuid:9c56958c-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: residualWaterContent2 fullUrl: urn:uuid:9c56968a-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: residualWaterContent3 fullUrl: urn:uuid:9c56978a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Observation Definition - Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Residual Water Content (w/w%) [documentation R4 R5 R6]
id: ResidualWaterContent
fullUrl: urn:uuid:fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
url (canonical): http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
Title: Residual Water Content (w/w%)
Status: active
Code: Residual Water Content (w/w%) [ResidualWaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Residual Water Content (w/w%)
Acceptable Value
Range: to 7.15% [%] (http://unitsofmeasure.org)
Criticality: Non-critical [Non-critical] (http://terminology.hl7.org/CodeSystem/observation-qualified-value-criticality) - Text: Non-critical
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Observation Definition - Reaction conversion: Residual Starting Material 1 by HPLC [Reaction conversion: Residual Starting Material 1 by HPLC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Reaction conversion: Residual Starting Material 1 by HPLC [documentation R4 R5 R6]
id: ResidualStartingMaterial1byHPLC
fullUrl: urn:uuid:fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
url (canonical): http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
Title: Reaction conversion: residual starting material 1 by HPLC (Step Aa) (LC area %)
Status: active
Code: Reaction conversion: Residual Starting Material 1 by HPLC [Reaction conversion: Residual Starting Material 1 by HPLC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Reaction conversion: Residual Starting Material 1 by HPLC
Acceptable Value
Range: to 23% [%] (http://unitsofmeasure.org)
Criticality: Critical [critical] (http://terminology.hl7.org/CodeSystem/observation-qualified-value-criticality) - Text: Critical
Action - Step 1 DS Release Testing Results - Step 1 DS Release Testing Results [Step1DSReleaseTestingResults] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Title: Step 1 DS Release Testing Results
Code: Step 1 DS Release Testing Results [Step1DSReleaseTestingResults] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Found a parent (Observation/instantiatesReference, id: appearanceSubstance1 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: appearanceSubstance2 fullUrl: urn:uuid:9c56948c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: appearanceSubstance3 fullUrl: urn:uuid:9c56948c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Observation Definition - Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance [documentation R4 R5 R6]
id: AppearanceSubstance
fullUrl: urn:uuid:fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
url (canonical): http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
Title: Appearance
Status: active
Code: Appearance [Appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Appearance
Method: Visual inspection
Acceptable Value
Text: White to off-white, to red, to orange, to brown solid
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Found a parent (Observation/instantiatesReference, id: identificationSubstance1 fullUrl: urn:uuid:9c56958c-2a39-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: identificationSubstance2 fullUrl: urn:uuid:9c56968c-2a49-6609-2c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: identificationSubstance3 fullUrl: urn:uuid:9c56978c-2a39-6609-2c01-4d197eb57a33)
which is linked to this by resource.id
Observation Definition - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC [documentation R4 R5 R6]
id: IdentificationSubstance
fullUrl: urn:uuid:3b1e878e-4bc9-8864-862f-e28b21233e8d
url (canonical): http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
Title: ID by HPLC
Status: active
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: ID by HPLC
Method: ID by UHPLC
Acceptable Value
Text: Conforms to standard
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Observation Definition - Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay by HPLC (as is) (w/w%) [documentation R4 R5 R6]
id: AssaySubstance
fullUrl: urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e
url (canonical): http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
Title: Assay by HPLC (as is) (w/w%)
Status: active
Code: Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Assay by HPLC (as is) (w/w%)
Method: Assay by UHPLC
Acceptable Value
Range: from 95% [%] (http://unitsofmeasure.org) to 101% [%] (http://unitsofmeasure.org)
Action - 2 - Step 2 Yield - Drying [drying] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Step (prefix): 2
Title: Step 2 Yield
Code: Drying [drying] (http://terminology.hl7.org/CodeSystem/manufacturing-step)
Description: Description of this step
Scale: Production Scale [PROD] (http://terminology.hl7.org/CodeSystem/manufacturing-step-scale)
Participant
Role: Starting Material [StartingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Starting material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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 (Substance/code, id: actual-batch-substance-starting-step2-1 fullUrl: urn:uuid:fc178762-81c5-5656-9744-13c7ad2e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-starting-step2-2 fullUrl: urn:uuid:fc178762-81d5-5656-9744-13c7ad1e596b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-starting-step2-3 fullUrl: urn:uuid:fc178762-81d5-5656-9744-23c7ad1e597b)
which is linked to this by resource.id
Substance - Stelbatosubstance2 [documentation R4 R5 R6]
id: startingMaterialStep2
fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153
Name: Stelbatosubstance2
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterialStep2 fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterialStep2 fullUrl: urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Batch Instance
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-step2-1 fullUrl: urn:uuid:fc178763-81c5-5656-9754-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start1Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-step2-1
fullUrl: urn:uuid:fc178762-81c5-5656-9744-13c7ad2e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start1Step2Amgen
Definition: Stelbatosubstance2 (SubstanceDefinition) id: startingMaterialStep2
Manufacturing
Date: 2019-09-02
Quantity: 7.1 kg
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-step2-2 fullUrl: urn:uuid:fc178764-81d5-5656-9764-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start2Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-step2-2
fullUrl: urn:uuid:fc178762-81d5-5656-9744-13c7ad1e596b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start2Step2Amgen
Definition: Stelbatosubstance2 (SubstanceDefinition) id: startingMaterialStep2
Manufacturing
Date: 2019-09-02
Quantity: 7.2 kg
Found a parent (Substance/valueReference, id: actual-batch-substance-itermediate-step2-3 fullUrl: urn:uuid:fc178764-81d6-6656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - Start3Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-starting-step2-3
fullUrl: urn:uuid:fc178762-81d5-5656-9744-23c7ad1e597b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Start3Step2Amgen
Definition: Stelbatosubstance2 (SubstanceDefinition) id: startingMaterialStep2
Manufacturing
Date: 2019-09-02
Quantity: 7.3 kg
Participant
Role: Intermediate Material [IntermediateMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Intermediate material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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 (Substance/code, id: actual-batch-substance-itermediate-step2-1 fullUrl: urn:uuid:fc178763-81c5-5656-9754-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-itermediate-step2-2 fullUrl: urn:uuid:fc178764-81d5-5656-9764-13c7ad1e595b)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-itermediate-step2-3 fullUrl: urn:uuid:fc178764-81d6-6656-9744-13c7ad1e595b)
which is linked to this by resource.id
Substance - ProcessoholStep2 [documentation R4 R5 R6]
id: intermediateMaterialStep2
fullUrl: urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155
Name: ProcessoholStep2
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterial fullUrl: urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: startingMaterialStep2 fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821153)
which is linked to this by resource.id
Found a parent (SubstanceDefinition/manufacturer, id: intermediateMaterialStep2 fullUrl: urn:uuid:c458791f-7cb8-428e-84f7-8a205f821155)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Batch Instance
Found a parent (Observation/subject, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed1Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-step2-1
fullUrl: urn:uuid:fc178763-81c5-5656-9754-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed1Step2Amgen
Definition: ProcessoholStep2 (SubstanceDefinition) id: intermediateMaterialStep2
Manufacturing
Quantity: 10.1 kg
Derived From: Start1Step2Amgen (Substance) id: actual-batch-substance-starting-step2-1
Found a parent (Observation/subject, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed2Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-step2-2
fullUrl: urn:uuid:fc178764-81d5-5656-9764-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed2Step2Amgen
Definition: ProcessoholStep2 (SubstanceDefinition) id: intermediateMaterialStep2
Manufacturing
Quantity: 10.2 kg
Derived From: Start2Step2Amgen (Substance) id: actual-batch-substance-starting-step2-2
Found a parent (Observation/subject, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Substance - Intermed3Step2Amgen [documentation R4 R5 R6]
id: actual-batch-substance-itermediate-step2-3
fullUrl: urn:uuid:fc178764-81d6-6656-9744-13c7ad1e595b
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
Instance: true
Identifier: Intermed3Step2Amgen
Definition: ProcessoholStep2 (SubstanceDefinition) id: intermediateMaterialStep2
Manufacturing
Quantity: 10.3 kg
Derived From: Start3Step2Amgen (Substance) id: actual-batch-substance-starting-step2-3
Participant
Role: Resulting Material [ResultingMaterial] (http://terminology.hl7.org/CodeSystem/manufacturing-participant-role)
Display: Resulting material
Found a parent (PlanDefinition/valueReference, id: validationProtocol 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
Substance - ResultothaneStep2 [documentation R4 R5 R6]
id: resultingMaterialStep2
fullUrl: urn:uuid:c458791f-8cb8-428e-83f7-8a205f821154
Name: ResultothaneStep2
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: validationProtocol 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 canonical resource.url
Found a parent (Observation/instantiatesReference, id: step2Yield1 fullUrl: urn:uuid:9c56948d-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: step2Yield2 fullUrl: urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Found a parent (Observation/instantiatesReference, id: step2Yield3 fullUrl: urn:uuid:9c56948b-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id
Observation Definition - Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%) [documentation R4 R5 R6]
id: Step2Yield
fullUrl: urn:uuid:fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
url (canonical): http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
Title: Yield (%)
Status: active
Code: Yield (%) [Yield (%)] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Yield (%)
Triggered: Process Validation Report (DiagnosticReport) id: processValidationReport