FMDVaccinePotencyAssayReviewer

FMD Vaccine Potency Assay

Vet veterinary veterinary vaccines animal health adjuvants aquaculture batch release CSV→JSON

Utility description: FMD Vaccine Potency Assay

FMD Vaccine Potency Assay Reviewer — FMD Vaccine Potency Test Review

ℹ️ Utility performs automatic verification of acceptance criteria for Foot-and-Mouth Disease (FMD) vaccine potency tests according to Ph. Eur. 2.7.16 and WOAH standards:
• Assay Validity: Check of standard curve coefficient of determination (R²) and control serum titer.
• Challenge Control: Confirmation that control animals were susceptible to the virus.
• Potency Calculation: Determination of PD50 dose (dose protecting 50% of animals) and comparison with minimum requirement (typically ≥ 3.0 PD50).
• Serotype Specificity: Separate analysis for serotypes O, A, Asia1, etc.

⚠️ IMPORTANT:
• FMD potency test is a complex biological assay requiring strict vivarium conditions.
• Invalid challenge control renders the entire test unsuitable for evaluation, regardless of vaccine results.

Usage:
FMDVaccinePotencyAssayReviewer.exe → demo mode (console output)
FMDVaccinePotencyAssayReviewer.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,Serotype,StdCurve_Slope,StdCurve_R2,ControlSerum_Titer_Log10,MinControlTiter_Limit,Vaccine_PD50_Dose,MinPD50_Requirement

Example:
FMD-001,O,-1.1,0.98,2.1,1.7,4.5,3.0

📍 Scope of Application (Usage Where):
• Veterinary Vaccine Production: Release of FMD vaccine batches.
• State Quality Control: Inspection testing in reference laboratories.
• Vaccine Development: Optimization of antigen and adjuvant composition.
• Regulatory Dossier: Preparation of data for product registration.

— WHY IS THIS NEEDED?
Efficacy of FMD vaccine is critically important for preventing epidemics.
Automated review eliminates errors in statistical parameter calculations (Probit analysis) and guarantees that only highly immunogenic batches reach the market.
This complies with GLP principles and international animal trade requirements.

⚠️ CRITICAL:
• Standard Curve R²: Must be ≥ 0.90 to ensure interpolation accuracy.
• Control Serum: Titer must be within historically established range, confirming reagents.
• PD50 Limit: For cattle, minimum is usually 3.0 PD50; for pigs, requirements may differ.
• Challenge Control: 100% morbidity in control group is mandatory for test validity.

Key features:
• Automatic system suitability check
• Test validity status calculation (Valid/Invalid)
• Comparison of obtained potency with regulatory requirements
• Support for multiple serotypes
• Report generation for LIMS integration

Critical parameters:
• Std Curve R²: ≥ 0.90
• Control Serum Titer: Within established limits
• Vaccine PD50: ≥ 3.0 (or per specification)
• Challenge Validity: True

💡 Usage tips:
1. Statistics: Use specialized software (e.g., CombiStats) for primary PD50 calculation, and this utility for review.
2. Historical Data: Compare current control titers with laboratory historical data.
3. Biosafety: All work with live virus is performed under BSL-3/4 conditions.
4. Alternative Methods: Consider using in vitro tests (146S ELISA) as screening.
5. Documentation: Save reports as part of the test protocol.

⚠️ Note: This utility checks data correctness and specification compliance. It does not replace expert assessment by pathologist and virologist during animal trials.

input.csv

BatchNumber,Serotype,StdCurve_Slope,StdCurve_R2,ControlSerum_Titer_Log10,MinControlTiter_Limit,Vaccine_PD50_Dose,MinPD50_Requirement
FMD-2026-O-001,O,-1.1,0.98,2.1,1.7,4.5,3.0
FMD-2026-A-002,A,-0.9,0.85,1.9,1.7,2.8,3.0
FMD-2026-Asia1-003,Asia1,-1.05,0.95,2.3,1.7,5.1,3.0

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of FMDVaccinePotencyAssayReviewer for FMD Vaccine Potency Assay Reviewer.

Domain limits URS input.csv FS IQ/OQ/PQ

Domain limits and critical parameters

Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.

FMD Vaccine Potency Assay Reviewer — FMD Vaccine Potency Test Review
ℹ️ Utility performs automatic verification of acceptance criteria for Foot-and-Mouth Disease (FMD) vaccine potency tests according to Ph. Eur. 2.7.16 and WOAH standards:
• Potency Calculation: Determination of PD50 dose (dose protecting 50% of animals) and comparison with minimum requirement (typically ≥ 3.0 PD50).
• FMD potency test is a complex biological assay requiring strict vivarium conditions.
FMDVaccinePotencyAssayReviewer.exe → demo mode (console output)
FMDVaccinePotencyAssayReviewer.exe input.csv output.json → evaluate your data
BatchNumber,Serotype,StdCurve_Slope,StdCurve_R2,ControlSerum_Titer_Log10,MinControlTiter_Limit,Vaccine_PD50_Dose,MinPD50_Requirement
Efficacy of FMD vaccine is critically important for preventing epidemics.
⚠️ CRITICAL:
• Standard Curve R²: Must be ≥ 0.90 to ensure interpolation accuracy.
• Control Serum: Titer must be within historically established range, confirming reagents.
• PD50 Limit: For cattle, minimum is usually 3.0 PD50; for pigs, requirements may differ.
• Comparison of obtained potency with regulatory requirements
Critical parameters:
• Std Curve R²: ≥ 0.90
• Control Serum Titer: Within established limits
• Vaccine PD50: ≥ 3.0 (or per specification)

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an input.csv file for FMD Vaccine Potency Assay Reviewer with headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions.	High	Identical input data, rule version and configuration produce reproducible results.
URS-003	The utility shall validate mandatory fields, data types, ranges, units and domain plausibility.	High	Schema, conversion and range errors are explicitly reported.
URS-004	The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs.	High	Each check has PASS/WARNING/FAIL and a clear message.
URS-005	The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall preserve traceability between batch/sample, input file, applied rules and final status.	High	Output contains identifiers, checked parameters and audit metadata.
URS-007	The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors.	Medium	URS, FS, input/output contract and test scenarios are supplied with the utility.
URS-008	The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision.	Medium	Documentation states change control and limit-verification expectations.

input.csv contract

#	Field	Type	Sample	Purpose
1	`BatchNumber`	string / controlled vocabulary	`FMD-2026-O-001`	Batch or lot identifier used for traceability.
2	`Serotype`	string / controlled vocabulary	`O`	Controlled input parameter for deterministic QC rules.
3	`StdCurve_Slope`	decimal	`-1.1`	Controlled input parameter for deterministic QC rules.
4	`StdCurve_R2`	decimal	`0.98`	Controlled input parameter for deterministic QC rules.
5	`ControlSerum_Titer_Log10`	string / controlled vocabulary	`2.1`	Control point/control sample for assay run validity.
6	`MinControlTiter_Limit`	decimal	`1.7`	Control point/control sample for assay run validity.
7	`Vaccine_PD50_Dose`	decimal	`4.5`	Dose/dosage unit; release and safety parameter.
8	`MinPD50_Requirement`	decimal	`3.0`	Controlled input parameter for deterministic QC rules.

BatchNumber,Serotype,StdCurve_Slope,StdCurve_R2,ControlSerum_Titer_Log10,MinControlTiter_Limit,Vaccine_PD50_Dose,MinPD50_Requirement
FMD-2026-O-001,O,-1.1,0.98,2.1,1.7,4.5,3.0
FMD-2026-A-002,A,-0.9,0.85,1.9,1.7,2.8,3.0
FMD-2026-Asia1-003,Asia1,-1.05,0.95,2.3,1.7,5.1,3.0

Input validation rules

ID	Field	Rule	Criticality
VR-001	`BatchNumber`	The field shall match an approved dictionary or accepted string representation.	High
VR-002	`Serotype`	The field shall match an approved dictionary or accepted string representation.	High
VR-003	`StdCurve_Slope`	The field shall match an approved dictionary or accepted string representation.	High
VR-004	`StdCurve_R2`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-005	`ControlSerum_Titer_Log10`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-006	`MinControlTiter_Limit`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-007	`Vaccine_PD50_Dose`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-008	`MinPD50_Requirement`	The field shall match an approved dictionary or accepted string representation.	Medium

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	Support execution modes: demo mode without arguments and production mode input.csv output.json.
FS-002	CSV import	Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns.
FS-003	Schema validation	Check mandatory fields, column count, unknown key fields and empty mandatory values.
FS-004	Type conversion	Convert numeric, flag and text values; invalid format is recorded as a row-level error.
FS-005	Domain rule engine	Apply rules for FMD Vaccine Potency Assay Reviewer, including critical limits from the description and approved specification.
FS-006	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-007	JSON export	Write output.json with detailed checks, source values, warnings, failures and critical findings.
FS-008	Audit support	Keep result structure suitable for review, deviation investigation and calculation reproduction.
FS-009	Integration contract	Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review.
FS-010	Error handling	Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format.

Example output.json

{
  "utilityId": "fmdvaccinepotencyassayreviewer",
  "utilityFolder": "FMDVaccinePotencyAssayReviewer",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "FMD-2026-O-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "Serotype",
      "value": "O",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "StdCurve_Slope",
      "value": "-1.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "StdCurve_R2",
      "value": "0.98",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "ControlSerum_Titer_Log10",
      "value": "2.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "MinControlTiter_Limit",
      "value": "1.7",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "Vaccine_PD50_Dose",
      "value": "4.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "MinPD50_Requirement",
      "value": "3.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "FMDVaccinePotencyAssayReviewer.documentation.html"
  }
}

Traceability matrix

URS	FS	Test	Evidence
URS-001	FS-001, FS-002	OQ-001	Verify execution and import of valid input.csv.
URS-002	FS-005, FS-006	OQ-004	Repeat the same dataset and compare output.json.
URS-003	FS-003, FS-004, FS-010	OQ-002, OQ-003	Verify missing columns and invalid types.
URS-004	FS-005, FS-006	OQ-004, PQ-001	Verify critical deviations on real/boundary data.
URS-005	FS-007, FS-009	OQ-005	Verify JSON schema and downstream-system suitability.
URS-006	FS-008	OQ-006	Verify identifiers and audit metadata.
URS-007	FS-008, FS-010	IQ-001, OQ-007	Verify documentation completeness and control evidence.
URS-008	FS-005, FS-008	PQ-002	Verify review workflow and no replacement of QA decision.

IQ/OQ/PQ test scenarios

ID	Scenario	Expected result
IQ-001	Verify executable, input.csv, documentation and checksum availability.	Delivery set is complete; version is recorded.
OQ-001	Valid sample row from input.csv.	PASS or acceptable WARNING according to rules.
OQ-002	Remove a mandatory CSV column.	Schema error or FAIL with missing-column reference.
OQ-003	Place a non-numeric value into a numeric field.	Type-conversion error with row/field reference.
OQ-004	Set a critical parameter outside the limit.	FAIL and critical finding.
OQ-005	Verify output.json structure.	All mandatory sections are present and JSON is valid.
OQ-006	Verify batch/sample traceability.	Input and result identifiers match.
PQ-001	Verify 3–5 real user batches/samples.	Result is confirmed by QC/QA review.
PQ-002	Verify deviation workflow and manual QA decision.	Utility supports review but does not replace approved decision.

QA/QC and change control

Do not rename columns without updating validator, documentation and test set.
Retain input.csv, output.json, executable version and checksum.
Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.

Included in packages

Vet — Veterinary QC Utilities

Vet is designed for veterinary pharmaceuticals and vaccines: adjuvants, antigens, autogenous vaccines, aquaculture, feed/premixes, antimicrobial and antiparasitic products, sterility and batch release.

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