Batch Analysis: CMC synthetic data rendering - drug substance - Pharmaceutical Quality (Industry) v1.0.0-ballot

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Batch Analysis: CMC 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.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.

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

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Bundle [documentation R4 R5 R6]

id: bundle-batch-analysis-pq-ex2-sub

Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq

Type: collection

Batch Analysis Report - Substance, on Stelbatolol

Diagnostic Report - Batch Analysis Report [Batch Analysis Report] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq) [documentation R4 R5 R6]

id: batchAnalysisReport

fullUrl: urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006

Date: 2020-12

Status: final

Code: Batch Analysis Report [Batch Analysis Report] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq)

Triggered By: S.4.4 BATCH ANALYSIS (PlanDefinition) id: specificationProtocol

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

Results: Batch Specification for Drug Substance

			Lot Number
Test Procedure	Acceptance Criteria	Method Reference	CAT1	CAT2	CAT3
Description	A white to brown powder	Visual inspection	Pass	Pass	Pass
Identification	Conforms with reference	Identification by IR spectroscopy Identification by HPLC	Conforms	Does not conform	Conforms
Assay	98 % w/w - 102 % w/w	Assay by LC	94 [%] (http://unitsofmeasure.org) [1]	95 [%] (http://unitsofmeasure.org) [1]	96 [%] (http://unitsofmeasure.org) [1]
Drug Substance Related Organic impurities
Impurity 1	NMT 0.5 % w/w	Organic impurities by LC	0.5 [%] (http://unitsofmeasure.org)	0.4 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
Impurity 2	NMT 0.5 % w/w		0.5 [%] (http://unitsofmeasure.org)	0.4 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
Impurity 3 [2]	NMT 0.5 % w/w		0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)
Any individual unspecified impurity	NMT 0.10 % w/w		0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)
Total impurities	NMT 2.0 % w/w		0.02 [%] (http://unitsofmeasure.org)	0.02 [%] (http://unitsofmeasure.org)	0.02 [%] (http://unitsofmeasure.org)
Mutagenic impurities	NMT 50 ppm	Impurity 5 content by LC-MS	20 [[ppm]] (http://unitsofmeasure.org)	22 [%] (http://unitsofmeasure.org)	18 [%] (http://unitsofmeasure.org)
Enantiomeric purity	NLT 99.6 %	Enantiomeric purity by LC	91.5 [%] (http://unitsofmeasure.org) [1]	91.5 [%] (http://unitsofmeasure.org) [1]	91.5 [%] (http://unitsofmeasure.org) [3]
Residual solvents
Solvent 1	NMT 0.1 % w/w	Residual solvents by headspace GC	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)
Solvent 2	NMT 2.0 % w/w	Residual solvents by headspace GC	1.4 [%] (http://unitsofmeasure.org)	1.5 [%] (http://unitsofmeasure.org)	1.2 [%] (http://unitsofmeasure.org)
Water Content	NMT 1.0 % w/w	USP Karl Fischer titration	0.8 [%] (http://unitsofmeasure.org)	0.8 [%] (http://unitsofmeasure.org)	0.8 [%] (http://unitsofmeasure.org)
Particle size distribution [4]
D(v,0.9)	NMT 319 µm	Laser diffraction	0.5 [%] (http://unitsofmeasure.org)	0.4 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
D(v,0.5)	NMT 145 µm		0.5 [%] (http://unitsofmeasure.org)	0.4 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
D(v,0.1)	NMT 20 µm		0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)

[1] CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
[2] Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data
[3] Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.
[4] Particle Size Distribution was included in the release specification throughout clinical development, and no longer forms a part of the commercial release specification; See Section S.4.5 Justification of Specification for data and rationale.

Result

Found a parent (DiagnosticReport/result, id: batchAnalysisReport fullUrl: urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006)
which is linked to this by resource.id

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

id: observation-test-result-drug-pq-ex2

fullUrl: urn:uuid:81f552f9-8458-3cf4-8379-eea5417a9de2

Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq

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

Status: final

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

Value: Pass

Subject: CAT1 (Substance) id: substance-drug-pq-ex1

Instantiates: Description - Plan: S.4.4 BATCH ANALYSIS (PlanDefinition) id: specificationProtocol (ObservationDefinition) id: Description

Performer

Found a parent (Observation/performer, id: observation-test-result-drug-pq-ex2 fullUrl: urn:uuid:81f552f9-8458-3cf4-8379-eea5417a9de2)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDescription2 fullUrl: urn:uuid:50bf6f69-a3f5-678b-469b-c5df5cca4c86)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDescription3 fullUrl: urn:uuid:145fd3b7-3678-867f-4298-a6c781b86de3)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationIdentification fullUrl: urn:uuid:55c89944-60d1-4eea-a2c3-6c53e3622bc5)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationIdentification2 fullUrl: urn:uuid:adb51ab6-00a9-1078-69e5-d32c025a857c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationIdentification3 fullUrl: urn:uuid:916a0ae2-9c43-72f0-a22a-c5f8ce902125)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay fullUrl: urn:uuid:6deb4306-1193-24ae-a565-f73225652bdd)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay2 fullUrl: urn:uuid:f6aabd2f-5902-57e7-6126-eccd9158a5b5)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay3 fullUrl: urn:uuid:32f598e4-a0e0-98dc-41dd-0f8397f953ad)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1 fullUrl: urn:uuid:02d9e6be-833c-1c6d-a64a-baa3935c959d)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1-2 fullUrl: urn:uuid:d3e572b7-14fd-744b-4123-58741d75571e)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1-3 fullUrl: urn:uuid:fe6ca484-a755-9a0b-a074-b6ee0a907ff8)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2 fullUrl: urn:uuid:da92c71f-a12a-1980-11a3-80e3d1852244)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2-2 fullUrl: urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2-3 fullUrl: urn:uuid:31bfeff4-4a7d-3be5-878e-fb674d3d5487)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3 fullUrl: urn:uuid:732237a9-4b3b-27cc-99ca-6b913e622a29)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3-2 fullUrl: urn:uuid:52afbeb4-4958-a275-a0ca-d70b2b5240ec)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3-3 fullUrl: urn:uuid:7fc395b1-59e4-78be-0512-cf92133c0fac)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified fullUrl: urn:uuid:9c98bd8a-7dda-2f01-0dbd-8c60b60e8572)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified-2 fullUrl: urn:uuid:97b16ff8-8e0f-915a-9d65-7fab108f40c2)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified-3 fullUrl: urn:uuid:0244eafe-3126-909b-7d8d-4253f45f525c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total fullUrl: urn:uuid:10b80cbd-45d3-9be1-63b9-29f04b47376c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total-2 fullUrl: urn:uuid:84f015ac-9572-324f-8013-0b999cc95bbd)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total-3 fullUrl: urn:uuid:987daeaa-4c2a-72b7-780f-4a9403163a3e)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationMutagenic fullUrl: urn:uuid:ff26533d-88a8-7f18-a275-42dc1373a388)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationMutagenic2 fullUrl: urn:uuid:c99666d2-7962-9a71-58f6-7b2e5aa662f5)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationMutagenic3 fullUrl: urn:uuid:c18e21d3-7113-4d08-4ff3-0c9718596f64)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationEnantiomericPurity fullUrl: urn:uuid:66fdac46-2a6b-a66f-891b-8dcf67cc46c7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationEnantiomericPurity2 fullUrl: urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationEnantiomericPurity3 fullUrl: urn:uuid:fc49ad55-07d1-997d-6695-bbff44746e75)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol1 fullUrl: urn:uuid:f8160692-a7a8-3fa6-9f35-e7df35f51ac0)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol1-2 fullUrl: urn:uuid:a531aee9-4c21-06af-352c-a3615b5d957e)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol1-3 fullUrl: urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol2 fullUrl: urn:uuid:ba8a182e-8571-6cbd-047b-612735d599d2)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol2-2 fullUrl: urn:uuid:0b5b94cc-7a1a-4ada-66c7-954ceb528d67)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationSolvents-sol2-3 fullUrl: urn:uuid:6afaacee-11a6-58b2-47df-5f79722c66ac)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater fullUrl: urn:uuid:c2644a86-1684-286e-00e2-dcaf907a8970)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater2 fullUrl: urn:uuid:cb5f6872-6eeb-727a-7c33-f2c438581a1c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater3 fullUrl: urn:uuid:7faaf980-7c10-7b9a-9572-1bacd485824e)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size1 fullUrl: urn:uuid:e4d2118a-8562-9eb1-2c14-4e145d2a95fc)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size1-2 fullUrl: urn:uuid:ec078717-9512-4db4-77c6-2c7e29d213a6)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size1-3 fullUrl: urn:uuid:05cfb495-2580-561a-688d-ce6ea24c8962)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size2 fullUrl: urn:uuid:d2a60ae5-96b4-3d13-38da-729c652347a3)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size2-2 fullUrl: urn:uuid:c3f51325-2f5f-194c-919b-2219ee1f5c45)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size2-3 fullUrl: urn:uuid:e9d89693-11b1-13ed-5cde-606fc1b8372c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size3 fullUrl: urn:uuid:2659b000-96e2-1b8b-129b-0c00e1074b0f)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size3-2 fullUrl: urn:uuid:10b47328-36fa-343d-5699-5b32b30a6d33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationParticleSize-size3-3 fullUrl: urn:uuid:e6780766-317a-382f-92d2-79825f506cc5)
which is linked to this by resource.id

Organization [documentation R4 R5 R6]

id: 378fbe5f-5926-3a5c-4c64-5428df877b08

fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

- Testing Lab

Name: Testing Lab

Found a parent (DiagnosticReport/result, id: batchAnalysisReport fullUrl: urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006)
which is linked to this by resource.id

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

id: observationDescription2

fullUrl: urn:uuid:50bf6f69-a3f5-678b-469b-c5df5cca4c86

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

Status: final

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

Value: Pass

Subject: CAT2 (Substance) id: actual-batch-substance-2