URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AclidiniumFormoterol_LabaLamaInhalerFDCQualityChecker for Aclidinium/Formoterol LABA/LAMA Inhaler Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of the combination inhaler (LABA/LAMA):
• • Aclidinium Content: 375–469 mcg/dose
• • Formoterol Content: 9.6–12.0 mcg/dose
• • Fine Particle Fraction (FPF): ≥15%
• • Dose Uniformity: deviation ≤15%
• • Moisture Content: ≤1.0%
• • Impurities: ≤1.5%
• • Valve Leak Rate: ≤0.5 mL/min
• ⚠️ CRITICAL: Low fine particle fraction reduces drug delivery to the lungs.
• BatchNumber,AclidiniumAssayMcgPerDose,FormoterolAssayMcgPerDose,FineParticleFractionPercent,DeliveredDoseUniformityDeviation,MoistureContentPercent,ImpuritiesTotalPercent,ValveLeakRateMlPerMin,ActuatorForceNewton
• • Dose uniformity and particle size are critical for delivery to lower respiratory tract
• ⚠️ CRITICAL:
• • Component content must be within a narrow range for therapeutic effect
• • Dose uniformity is critical for patient safety with each inhalation
• • Stability check of composition (moisture, impurities)
• Critical parameters:
• • Aclidinium Assay: 375–469 mcg/dose
• • Formoterol Assay: 9.6–12.0 mcg/dose

URS — User Requirements Specification

input.csv contract

BatchNumber,AclidiniumAssayMcgPerDose,FormoterolAssayMcgPerDose,FineParticleFractionPercent,DeliveredDoseUniformityDeviation,MoistureContentPercent,ImpuritiesTotalPercent,ValveLeakRateMlPerMin,ActuatorForceNewton
ACL-FOR-2026-001,422.0,10.8,18.5,8.2,0.4,0.8,0.2,20.5
ACL-FOR-2026-002,400.0,11.0,16.0,10.0,0.5,0.9,0.3,19.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "aclidinium-formoterol-laba-lama-inhaler-fdc-quality-checker",
  "utilityFolder": "AclidiniumFormoterol_LabaLamaInhalerFDCQualityChecker",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ACL-FOR-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AclidiniumAssayMcgPerDose",
      "value": "422.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "FormoterolAssayMcgPerDose",
      "value": "10.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "FineParticleFractionPercent",
      "value": "18.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "DeliveredDoseUniformityDeviation",
      "value": "8.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "ImpuritiesTotalPercent",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ValveLeakRateMlPerMin",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "ActuatorForceNewton",
      "value": "20.5",
      "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": "AclidiniumFormoterol_LabaLamaInhalerFDCQualityChecker.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.
• For combination products, document whether the specialized FDC utility or fallback component checks were used.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.