PotencyAssayAnimalModelCompliance_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of PotencyAssayAnimalModelCompliance_QualityChecker for Potency Assay Animal Model Compliance Quality Checker.

Domain limits and critical parameters

• Potency Assay Animal Model Compliance Quality Checker — Control of In Vivo Potency Tests
• ℹ️ Utility assesses results of biological potency tests for vaccines requiring laboratory animals (according to specific Ph. Eur., USP monographs):
• • Potency: Calculated value in International Units (IU).
• • Statistical Significance: Lower Confidence Limit (P=0.95) must exceed minimum required level.
• • Model Validity: Control group must show expected level of disease/mortality upon challenge.
• ⚠️ CRITICAL:
• • Even if mean potency is high, if Lower Confidence Limit is below limit — batch is rejected (insufficient statistical confidence).
• PotencyAssayAnimalModelComplianceQualityChecker.exe → demo mode (console output)
• PotencyAssayAnimalModelComplianceQualityChecker.exe input.csv output.json → evaluate your data
• BatchNumber,ProductName,AnimalSpecies,Potency_IU_per_ml,LowerConfidenceLimit_95,UpperConfidenceLimit_95,MinRequiredPotency,TotalAnimalsUsed,MortalityControlGroup_Percent,MortalityTestGroup_Percent,EthicalComplianceCheck
• For some vaccines (whole-cell pertussis, anthrax, some rabies forms), fully validated alternative in vitro methods are not yet developed.
• • Challenge Control: In protection assays, unvaccinated animals must die/get sick. If they survive, the vaccine is not to blame — the test is bad.
• • Animal Welfare: Monitoring of pain, suffering, and distress is mandatory. Animals with severe symptoms must be euthanized per protocol.
• • Alternatives (3R): Industry is actively moving to replace these tests with serological methods (in vitro potency) where possible.
• • Statistical significance check of potency (LCL 95%)
• Critical parameters:
• • Potency: ≥ Specification
• • Lower Confidence Limit (95%): ≥ Specification

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,AnimalSpecies,Potency_IU_per_ml,LowerConfidenceLimit_95,UpperConfidenceLimit_95,MinRequiredPotency,TotalAnimalsUsed,MortalityControlGroup_Percent,MortalityTestGroup_Percent,EthicalComplianceCheck
POT-ANIM-2026-001,Pertussis Whole Cell,Mouse,8.5,6.2,11.0,4.0,40,80,10,Pass
POT-ANIM-2026-002,Anthrax Vaccine,Guyinea Pig,12.0,9.5,15.0,5.0,30,90,5,Pass
POT-FAIL-STAT-003,DTPa Vaccine,Mouse,4.5,3.8,5.2,4.0,40,85,15,Pass

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "potencyassayanimalmodelcompliance-qualitychecker",
  "utilityFolder": "PotencyAssayAnimalModelCompliance_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "POT-ANIM-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Pertussis Whole Cell",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "AnimalSpecies",
      "value": "Mouse",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "Potency_IU_per_ml",
      "value": "8.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "LowerConfidenceLimit_95",
      "value": "6.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "UpperConfidenceLimit_95",
      "value": "11.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "MinRequiredPotency",
      "value": "4.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "TotalAnimalsUsed",
      "value": "40",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MortalityControlGroup_Percent",
      "value": "80",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MortalityTestGroup_Percent",
      "value": "10",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "EthicalComplianceCheck",
      "value": "Pass",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "PotencyAssayAnimalModelCompliance_QualityChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

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.