InactivatedVaccineSafetyTest_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of InactivatedVaccineSafetyTest_QualityChecker for Inactivated Vaccine Safety Test Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility assesses the completeness of pathogen inactivation in inactivated vaccines (IPV, Rabies, Influenza, Encephalitis) according to Ph. Eur. 2.6.16, 2.6.17 and WHO requirements:
• • System Validity: Cell control must be viable, and virus control (sensitivity) must show growth.
• ⚠️ CRITICAL:
• • Detection of even one positive subculture means INCOMPLETE INACTIVATION. This is a critical batch failure.
• • Sensitivity: Method must be able to detect 1 infectious dose.
• • Residual Inactivator: Its presence in small doses is sometimes required to guarantee that any accidental survivors are inactivated during storage, but its level is strictly toxicologically limited.
• • Specificity: Used cell lines must be susceptible to the given virus.
• • Compliance with GMP and Pharmacopoeia requirements
• Critical parameters:
• • Incubation Days: ≥ 14 (or as per monograph)
• • Cell Survival: ≥ 80%
• • Residual Formalin/BPL: Within safe limit
• 1. Asepsis: During safety testing, risk of contamination must be excluded to prevent false-positive results leading to rejection of a good batch.
• 2. Observation: CPE (Cytopathic Effect) must be assessed by a qualified microbiologist regularly.
• 3. Confirmation: If growth is suspected, a confirmatory test (e.g., PCR or immunofluorescence) is performed.
• 4. Process Validation: Inactivation process must be validated with a large safety margin (Kinetics of Inactivation).
• 5. Documentation: All cell observations must be documented by day.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,TotalSubcultures,PositiveSubcultures,IncubationDays,CellControlSurvival_Percent,VirusControlTiter_Log10,InactivatingAgent,ResidualInactivator_ppm
INV-SAFE-2026-001,Inactivated Polio Vaccine,3,0,21,95.0,6.5,Formalin,15.0
INV-SAFE-2026-002,Rabies Vaccine,2,0,14,90.0,5.8,BPL,2.0
INV-FAIL-2026-003,Influenza Split,3,1,21,92.0,6.0,Formalin,18.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "inactivatedvaccinesafetytest-qualitychecker",
  "utilityFolder": "InactivatedVaccineSafetyTest_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "INV-SAFE-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Inactivated Polio Vaccine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "TotalSubcultures",
      "value": "3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "PositiveSubcultures",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "IncubationDays",
      "value": "21",
      "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": "VirusControlTiter_Log10",
      "value": "6.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "InactivatingAgent",
      "value": "Formalin",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "ResidualInactivator_ppm",
      "value": "15.0",
      "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": "InactivatedVaccineSafetyTest_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.