VaccinePotencyTCID50_EID50_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of VaccinePotencyTCID50_EID50_QualityChecker for Vaccine Potency TCID50/EID50 Quality Checker.

Domain limits and critical parameters

• Vaccine Potency TCID50/EID50 Quality Checker — Control of Vaccine Titer (TCID50 / EID50)
• ℹ️ Utility assesses the potency of live veterinary vaccines using Tissue Culture Infectious Dose (TCID50) or Egg Infectious Dose (EID50) methods:
• • Comparison of calculated titer (log10) with minimum required activity level
• • Cell Control validity check: Cell survival must be high (>80%) to exclude medium toxicity
• ⚠️ CRITICAL:
• • If cell control survival is low (<80%), the test is considered INVALID, as CPE may be caused by toxicity rather than virus.
• VaccinePotencyTCID50_EID50_QualityChecker.exe → demo mode (console output)
• VaccinePotencyTCID50_EID50_QualityChecker.exe input.csv output.json → evaluate your data
• Unlike inactivated vaccines where antigen mass matters, here the number of viable infectious units is critical.
• • Cell Control: Must show no CPE (Cytopathic Effect). If cells die in control, reagents or culture conditions are unsuitable.
• • Back Titration: Performed parallel to main test to confirm dilution accuracy. Deviation > 0.5-1.0 log from target requires investigation.
• • Statistics: Titer calculation must be performed using validated statistical methods (Spearman-Kärber or Reed-Muench).
• • Compliance with Ph. Eur. 5.2.14 and VICH GL53 requirements
• Critical parameters:
• • Titer: ≥ Minimum Required (specified in dossier)
• • Cell Control Survival: ≥ 80%
• 1. Culture Purity: Use only mycoplasma-free cell lines. Mycoplasma can distort titration results.
• 5. Documentation: All raw data (number of positive wells at each dilution) must be saved for audit.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,MethodType,CalculatedTiter_Log10,MinRequiredTiter_Log10,CellControlSurvival_Percent,VirusBackTitration_Log10,NumberOfReplicates,CPE_Observation_Days
VAC-TCID-2026-001,IBR Live Vaccine,TCID50,7.5,6.5,95.0,4.0,8,3,5,7
VAC-EID-2026-002,Newcastle Disease Vaccine,EID50,9.2,8.5,100.0,5.5,5,3,4
VAC-FAIL-2026-003,BVDV Vaccine,TCID50,6.0,6.5,50.0,3.8,8,3,5,7

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "vaccinepotencytcid50-eid50-qualitychecker",
  "utilityFolder": "VaccinePotencyTCID50_EID50_QualityChecker",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "VAC-TCID-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "IBR Live Vaccine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "MethodType",
      "value": "TCID50",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "CalculatedTiter_Log10",
      "value": "7.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "MinRequiredTiter_Log10",
      "value": "6.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "CellControlSurvival_Percent",
      "value": "95.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "VirusBackTitration_Log10",
      "value": "4.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "NumberOfReplicates",
      "value": "8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "CPE_Observation_Days",
      "value": "3,5,7",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "VaccinePotencyTCID50_EID50_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.