Process Validation: synthetic data rendering - drug product - 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

Process Validation: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.3 Manufacture , subsection 3.2.P.3.5 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-ex1

Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq

Type: collection

Process Validation Report, on Stelbat Tablets, 20mg

Table 1. Batches Used in Stelbat Tablets, 20mg Drug Product Process Validation

Drug Product Batch Number	Date of Manufacture	Strength (mg/vial)	Batch Designation	Vessel Volume (L)		Drug Substance Batch Number	Batch Size (kg)		Target Fill Weight (g)	Number of Vials
Drug Product Batch Number	Date of Manufacture	Strength (mg/vial)	Batch Designation	Formulation Mixing Bag	Receiving Tank	Drug Substance Batch Number	Formulated Drug Product	Filtered Formulated Drug Product	Target Fill Weight (g)	Number of Vials
33445	2020-06	20mg	Maximum	1000	1200	CAT1	4.81	4.91	30	3
33446	2020-06	20mg	Maximum	1000	1200	CAT2	4.82	4.92	30	4
33447	2020-06	20mg	Maximum	1000	1200	CAT3	4.83	4.93	30	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...

Results: Compounding Step

		Lot Number
Test Procedure	Acceptance Criteria	33445	33446	33447
pH (adjustment of pre-clarification bulk solution)	6.9 pH - 7.1 pH	6.91 [pH] (http://unitsofmeasure.org)	6.92 [pH] (http://unitsofmeasure.org)	6.93 [pH] (http://unitsofmeasure.org)
pH (post-dilution bulk solution)	7.0 pH - 7.1 pH	7.01 [pH] (http://unitsofmeasure.org)	7.02 [pH] (http://unitsofmeasure.org)	6.93 [pH] (http://unitsofmeasure.org)
Assay (pre-clarification filtration) (mg/mL)	NLT 22 mg/mL	21.1 [mg/mL] (http://unitsofmeasure.org)	21.2 [mg/mL] (http://unitsofmeasure.org)	21.3 [mg/mL] (http://unitsofmeasure.org)
Assay (Post dilution bulk solution) (mg/mL)	20 mg/mL - 21 mg/mL	20.1 [mg/mL] (http://unitsofmeasure.org)	20.2 [mg/mL] (http://unitsofmeasure.org)	20.3 [mg/mL] (http://unitsofmeasure.org)

Results: Filling Steps

		Lot Number
Test Procedure	Acceptance Criteria	33445	33446	33447
TAMC [a]	NMT 10 CFU/100ml	9.1
TYMC [a]	NMT 10 CFU/100ml
Fill Weight Average	N/A
Fill Weight Target	N/A
Actual Avg. Weight from Target	± 2% target (%)
Hold Time (filtration To filling)	NMT 2.5 hours
Hold Time (start filling to end filling)	NMT 1.25 hours
Filter Integrity Test	NLT 3.5 psi

CFU = colony forming units; psi = pounds per square inch; TAMC = total aerobic microbial count; TYMC = total yeasts and molds counts

[a] Bioburden samples collected from bulk solution prior to sterile filtration.

Results: Lyophilization Step

		Lot Number
Test Procedure	Acceptance Criteria	No. of Locations	33445	No. of Locations	33446	No. of Locations	33447
Lyophilizer Number			1234		1235		1236
Assay	95% to 105% of label claim	3	97 [%] (http://unitsofmeasure.org)	4	98 [%] (http://unitsofmeasure.org)	2	96 [%] (http://unitsofmeasure.org)
Water Content	NMT 1.2 % w/w

Additional Homogeneity Analysis Results

		Lot Number 33445
Test Parameter	Homogeneity Acceptance Criteria	Do statistically significant effects	Lower one-sided 95% confidence limit of Max Difference	Upper one-sided 95% confidence limit of Max Difference	Was Homogeneity demonstrated?
Moisture (%)	± 1.4 % (w/w)	Yes	0.8	0.9	Yes
Assay by HPLC (% Main Peak)	± 2.3%	No	Not calculated	Not calculated	Yes

Results: Release Step

		Lot Number
Test Procedure	Acceptance Criteria	33445	33446	33447
Appearance (Product Container, visual)	1) Clear glass vial sealed with a gray rubber stopper and a flip off overseal 2) No visible damage or breach of vial container or closure
Appearance (Lyophilized, Visual)	White to off white cake or powder, essentially free from evidence of contamination with no visible foreign particulates
Appearance (Reconstituted, Visual)	Clear, colorless to slightly yellow solution, essentially free of visible particulates
Identification	Consistent with the retention time and UV spectrum of the reference standard	Complies	Does not comply	Complies
Assay	95% to 105% of label claim	103 [%] (http://unitsofmeasure.org)	102 [%] (http://unitsofmeasure.org)	101 [%] (http://unitsofmeasure.org)
Degradation Products
Impurity 1	NMT 0.2 % w/w	0.1 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
Impurity 2	NMT 0.3 % w/w	0.2 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
Impurity 3	NMT 0.3 % w/w	0.2 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)	0.2 [%] (http://unitsofmeasure.org)
Individual unspecified degradation products	NMT 0.2 % w/w	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)	0.1 [%] (http://unitsofmeasure.org)
Total degradation products	NMT 1.4 % w/w	0.6 [%] (http://unitsofmeasure.org)	0.7 [%] (http://unitsofmeasure.org)	0.6 [%] (http://unitsofmeasure.org)
Water Content	NMT 1.0 % w/w	0.5 [%] (http://unitsofmeasure.org)	0.5 [%] (http://unitsofmeasure.org)	0.5 [%] (http://unitsofmeasure.org)
Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)	NLT 97 %
Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)	NMT 25
pH (reconstituted)	6.95 pH - 7.05 pH

µm = micrometer; EU = endotoxin unit; mOsm = milliosmole; n = number; Ph. Eur. = European Pharmacopeia; USP = United States Pharmacopeia

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

id: observationIdentification

fullUrl: urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629

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: Identification

Value: Complies

Subject: Lot Number: 33445 (Medication) id: medication-batch-information-drug-pq-ex1

Instantiates: Identification - Plan: DP PROCESS VALIDATION (PlanDefinition) id: validationProtocol (ObservationDefinition) id: Identification

Performer

Found a parent (Observation/performer, id: observationIdentification fullUrl: urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationIdentification2 fullUrl: urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationIdentification3 fullUrl: urn:uuid:cfde6776-673c-72e2-68c4-07b77cd85b74)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPre1 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPre2 fullUrl: urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPre3 fullUrl: urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPost1 fullUrl: urn:uuid:9c56948a-3a49-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPost2 fullUrl: urn:uuid:9c56958a-4a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingpHPost3 fullUrl: urn:uuid:9c56948a-5a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPre1 fullUrl: urn:uuid:9c56948a-2a39-6609-1c01-4d297ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPre2 fullUrl: urn:uuid:9c56948a-3a39-6619-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPre3 fullUrl: urn:uuid:9c56948a-4a39-6619-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPost1 fullUrl: urn:uuid:9c56948a-3a49-6619-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPost2 fullUrl: urn:uuid:9c56958a-4a39-6619-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: compoundingAssayPost3 fullUrl: urn:uuid:9c56948a-5a39-6709-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay fullUrl: urn:uuid:9c56948a-1a39-6609-1c01-4d197ea57a33)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay2 fullUrl: urn:uuid:1e20aed7-7626-1664-8d96-235f860d9a2c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationAssay3 fullUrl: urn:uuid:ec6d7e30-4d70-491b-0669-a613eedd3c60)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1 fullUrl: urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1-2 fullUrl: urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp1-3 fullUrl: urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2 fullUrl: urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2-2 fullUrl: urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp2-3 fullUrl: urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3 fullUrl: urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3-2 fullUrl: urn:uuid:be016630-8754-7414-9014-21e020ad66c6)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp3-3 fullUrl: urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified fullUrl: urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified-2 fullUrl: urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-unspecified-3 fullUrl: urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total fullUrl: urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total-2 fullUrl: urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationDegradation-imp-total-3 fullUrl: urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater fullUrl: urn:uuid:66c2f585-678e-78b8-2235-1a3b37bd6e46)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater2 fullUrl: urn:uuid:f8232d25-023d-679f-9c58-a6dc234b7a28)
which is linked to this by resource.id

Found a parent (Observation/performer, id: observationWater3 fullUrl: urn:uuid:368b82be-75dd-1d97-3dbc-a7eed9869daa)
which is linked to this by resource.id

Found a parent (Observation/performer, id: fillingTAMC1 fullUrl: urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: fillingConclusion-nosubject fullUrl: urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizationConclusion-nosubject fullUrl: urn:uuid:45ab47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizerNumber1 fullUrl: urn:uuid:37aa47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizerNumber2 fullUrl: urn:uuid:38aa47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizerNumber3 fullUrl: urn:uuid:38aa48fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizationAssay1 fullUrl: urn:uuid:37aa47fd-7964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizationAssay2 fullUrl: urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizationAssay3 fullUrl: urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e8)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizerWaterHomogeneity1 fullUrl: urn:uuid:47aa47fd-8964-4f96-6495-b2bec7f160e7)
which is linked to this by resource.id

Found a parent (Observation/performer, id: lyophilizerAssayHomogeneity1 fullUrl: urn:uuid:47aa47fd-8964-5f96-6495-b2bec7f160e7)
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: Identification [documentation R4 R5 R6]

id: observationIdentification2

fullUrl: urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5

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: Identification

Value: Does not comply

Subject: Lot Number: 33446 (Medication) id: medication-actual-batch-2