ColdChainShippingTemperatureAndMKT_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of ColdChainShippingTemperatureAndMKT_QualityChecker for Cold Chain Shipping Temperature And MKT Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility performs deep analysis of temperature profiles during pharmaceutical cargo transportation according to USP <1079> and Ph. Eur. 5.2.2:
• • Absolute Limits: Check for exceedance of minimum and maximum allowable temperatures.
• • Freezing Detection: Critical check for biopharmaceutical products.
• • Thermal Stress Assessment: Comparison of MKT with established limit (usually equal to upper storage range boundary).
• ShipmentID,ProductName,StorageCondition,MinTemp_C,MaxTemp_C,AvgTemp_C,MKT_C,LimitLow_C,LimitHigh_C,MKT_Limit_C
• ⚠️ CRITICAL:
• • Freezing: For most liquid forms, dropping below 0°C or 2°C is critical failure, regardless of MKT.
• • MKT Limit: Exceeding MKT over upper range limit (e.g., >8°C for cold chain) indicates significant stability loss.
• • Comprehensive absolute temperature limit check
• • Compliance with USP and WHO TRS 953 requirements
• Critical parameters:
• • Min Temp: Must be >= Limit Low
• • Max Temp: Must be <= Limit High
• • MKT: Must be <= MKT Limit
• 2. Sensor Placement: Sensors must be located near product, not on container walls.
• 5. Training: Personnel must understand difference between average temperature and MKT.

URS — User Requirements Specification

input.csv contract

ShipmentID,ProductName,StorageCondition,MinTemp_C,MaxTemp_C,AvgTemp_C,MKT_C,LimitLow_C,LimitHigh_C,MKT_Limit_C
SHIP-2026-MKT-001,Insulin Glargine,2-8C,3.2,7.8,5.1,5.3,2.0,8.0,8.0
SHIP-2026-MKT-002,Vaccine X,2-8C,1.5,9.5,5.5,6.8,2.0,8.0,8.0
SHIP-2026-MKT-003,Monoclonal Ab,CRT,18.0,24.5,21.0,21.5,15.0,25.0,25.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "coldchainshippingtemperatureandmkt-qualitychecker",
  "utilityFolder": "ColdChainShippingTemperatureAndMKT_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "ShipmentID",
      "value": "SHIP-2026-MKT-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Insulin Glargine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "StorageCondition",
      "value": "2-8C",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "MinTemp_C",
      "value": "3.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "MaxTemp_C",
      "value": "7.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "AvgTemp_C",
      "value": "5.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "MKT_C",
      "value": "5.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "LimitLow_C",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "LimitHigh_C",
      "value": "8.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MKT_Limit_C",
      "value": "8.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "ColdChainShippingTemperatureAndMKT_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.