Stability Study: synthetic data rendering - drug substance - Pharmaceutical Quality (Industry) v1.0.0

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

Stability Study: 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.7 Stability, subsection 3.2.S.7.3 Stability Data.

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-drug-stability-pq-ex2-sub

Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq

Type: collection

Stability Report - Substance, on Stelbatolol

Details of Batches

Batches Table

Stability Protocol Number	PLO555	PLO555	PLO555
Drug Substance Batch Number	CAT1	CAT2	CAT3
Batch Size (kg)	120	120	120
Scale	Production	Production	Production
Site of Manufacture	AAA Molybdenum Products, Inc., Broomfield	AAA Molybdenum Products, Inc., Broomfield	AAA Molybdenum Products, Inc., Broomfield
Date of Manufacture	2020-01	2020-02	2020-03
Date Stability Started Substance	2020-06	2020-06	2020-06
Date Presented (Months)	18	18	18

Diagnostic Report - Stability Study Report [Stability Study Report] (http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type) [documentation R4 R5 R6]

id: studyResultsReport

fullUrl: urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003

Identifier: PLO555 (https://eudract.europa.eu/example/identifier)

Date: 2019-09-08

Time Point Description: Delayed Start Code [Delayed Start Code] (http://terminology.hl7.org/CodeSystem/time-point-description)

Status: final

Code: Stability Study Report [Stability Study Report] (http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type)

Triggered By: Stability Monitoring Program (PlanDefinition) id: stabilityStudyProtocol

Statistical Model: information about statistical model utilized to interpret stability study results

Container Orientation: horizontal [horizontal] (http://terminology.hl7.org/CodeSystem/container-orientation) - Text: Horizontal

Conclusion: The samples have been assessed and the conclusion is...

Performer

Found a parent (DiagnosticReport/performer, id: studyResultsReport fullUrl: urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003)
which is linked to this by resource.id

Organization [documentation R4 R5 R6]

id: tester

fullUrl: urn:uuid:6049d921-9935-90b7-4efc-894a66483c00

- Advanced Analytical Testing Laboratories Inc.

Identifier: 3007270600 (urn:oid:2.16.840.1.113883.4.82)

Active: true

Name: Advanced Analytical Testing Laboratories Inc.

Type: Analytical Testing - Stability [analytical-testing-stability] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)

Contact

Address: 30 Silverline Drive, North Brunswick, New Jersey, 08902, USA

Results Table
Batch: CAT1

Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Drug-related Impurities Content by LC (% w/w)				Identification
Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Impurity	Impurity 2	Any Unspecified Impurity	Total Impurities	Identification
Specification		A white to brown powder	98 % w/w - 102 % w/w	NMT 0.5 % w/w	NMT 0.52 % w/w	NMT 0.10 % w/w	NMT 2.0 % w/w	Complies
Initial	0	Complies	0.15 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)	<0.05 [%] (http://unitsofmeasure.org)	0.8 [%] (http://unitsofmeasure.org)	Complies
30°C/65% RH	3
	6
	9
	12
	18	Complies	0.118 [%] (http://unitsofmeasure.org)	0.118 [%] (http://unitsofmeasure.org)	0.218 [%] (http://unitsofmeasure.org)	<0.0518 [%] (http://unitsofmeasure.org)	0.818 [%] (http://unitsofmeasure.org)	Complies
	24
	36
40°C/75% RH
	3	Doesn't comply	0.113 [%] (http://unitsofmeasure.org)	0.113 [%] (http://unitsofmeasure.org)	0.213 [%] (http://unitsofmeasure.org)	<0.0513 [%] (http://unitsofmeasure.org)	0.813 [%] (http://unitsofmeasure.org)	Complies
	6

Results Table
Batch: CAT2

Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Drug-related Impurities Content by LC (% w/w)				Identification
Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Impurity	Impurity 2	Any Unspecified Impurity	Total Impurities	Identification
Specification		A white to brown powder	98 % w/w - 102 % w/w	NMT 0.5 % w/w	NMT 0.52 % w/w	NMT 0.10 % w/w	NMT 2.0 % w/w	Complies
Initial	0	Complies	0.152 [%] (http://unitsofmeasure.org)	0.12 [%] (http://unitsofmeasure.org)	0.22 [%] (http://unitsofmeasure.org)	<0.052 [%] (http://unitsofmeasure.org)	0.82 [%] (http://unitsofmeasure.org)	Does not comply
30°C/65% RH	3
	6
	9
	12
	18	Complies	0.118 [%] (http://unitsofmeasure.org)	0.118 [%] (http://unitsofmeasure.org)	0.218 [%] (http://unitsofmeasure.org)	<0.0518 [%] (http://unitsofmeasure.org)	0.818 [%] (http://unitsofmeasure.org)	Complies
	24
	36
40°C/75% RH
	3
	6

Results Table
Batch: CAT3

Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Drug-related Impurities Content by LC (% w/w)				Identification
Storage Condition	Time (Months)	Description	Assay (% w/w) (Mean)	Impurity	Impurity 2	Any Unspecified Impurity	Total Impurities	Identification
Specification		A white to brown powder	98 % w/w - 102 % w/w	NMT 0.5 % w/w	NMT 0.52 % w/w	NMT 0.10 % w/w	NMT 2.0 % w/w	Complies
Initial	0	Complies	0.152 [%] (http://unitsofmeasure.org)	0.12 [%] (http://unitsofmeasure.org)	0.22 [%] (http://unitsofmeasure.org)	<0.052 [%] (http://unitsofmeasure.org)	0.82 [%] (http://unitsofmeasure.org)	Does not comply
30°C/65% RH	3
	6
	9
	12
	18	Complies	0.118 [%] (http://unitsofmeasure.org)	0.118 [%] (http://unitsofmeasure.org)	0.218 [%] (http://unitsofmeasure.org)	<0.0518 [%] (http://unitsofmeasure.org)	0.818 [%] (http://unitsofmeasure.org)	Complies
	24
	36
40°C/75% RH
	3
	6

Result

Found a parent (DiagnosticReport/result, id: studyResultsReport fullUrl: urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003)
which is linked to this by resource.id

Observation - Test Components - Long-term 25C etc - Initial (XYZ) [documentation R4 R5 R6]

id: LongTerm30C-initial-1

fullUrl: urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c

Date: 2023-01-01T12:00:00Z

Status: final

Code: Test Components - Long-term 25C etc - Initial (XYZ)

Triggered By: Long-term - 30°C/65% RH - XY (ActivityDefinition) id: activityLongTerm30XY-Initial

Subject: CAT1 (Substance) id: actual-batch-substance

Specimen

[documentation R4 R5 R6]

id: stabilityInitial-1

fullUrl: urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5

Collection

Collected Date Time: 2020-06

Processing

Description: No storage

Processing

Description: 25°C/60% RH

Performer

Found a parent (Observation/performer, id: LongTerm30C-initial-1-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-Impurity1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-Impurity2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-ImpurityUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-ImpurityTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-1 fullUrl: urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Degradation-imp1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Degradation-imp2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Degradation-impUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Degradation-impTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-2-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-Initial-2 fullUrl: urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf)
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Degradation-imp1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Degradation-imp2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Degradation-impUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Degradation-impTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-initial-3-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-Initial-3 fullUrl: urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4)
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-Impurity1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-Impurity2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-ImpurityUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-ImpurityTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-1-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m fullUrl: urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900)
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-Impurity1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-Impurity2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-ImpurityUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-ImpurityTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-2 fullUrl: urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904)
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-Impurity1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-Impurity2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-ImpurityUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-ImpurityTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: LongTerm30C-18m-3 fullUrl: urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377)
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-Description fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-Impurity1 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-Impurity2 fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-ImpurityUnspecified fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-ImpurityTotal fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-Assay fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m-1-Identification fullUrl: (none))
which is linked to this by resource.id

Found a parent (Observation/performer, id: Accelerated40C-3m fullUrl: urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd)
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 - Stability [analytical-testing-stability] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)

Member

Found a parent (Observation/hasMember, id: LongTerm30C-initial-1 fullUrl: urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c)
which is linked to this by contained resource.id

Observation - Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description [documentation R4 R5 R6]

id: LongTerm30C-initial-1-Description

fullUrl: (none)

Date: 2023-01-01T12:00:00Z

Status: final

Code: Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example) - Text: Description

Value: Complies

Instantiates: Description (ObservationDefinition) id: Description