URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BudesonideGlycopyrroniumFormoterolQualityChecker for Budesonide/Glycopyrronium/Formoterol Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of triple combination (ICS/LAMA/LABA):
• • Budesonide Content: 144–198 mcg/dose
• • Glycopyrronium Content: 7.2–10.8 mcg/dose
• • Formoterol Content: 3.6–5.4 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 delivery of all three components to the lungs.
• BatchNumber,BudesonideAssay,GlycopyrroniumAssay,FormoterolAssay,FineParticleFraction,DDUDeviation,Moisture,Impurities,ValveLeak,ActuatorForce
• ⚠️ 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:
• • Budesonide Assay: 144–198 mcg/dose
• • Glycopyrronium Assay: 7.2–10.8 mcg/dose

URS — User Requirements Specification

input.csv contract

BatchNumber,BudesonideAssay,GlycopyrroniumAssay,FormoterolAssay,FineParticleFraction,DDUDeviation,Moisture,Impurities,ValveLeak,ActuatorForce
BGF-2026-001,160.0,9.0,4.5,20.5,7.0,0.4,0.7,0.2,19.0
BGF-2026-002,155.0,8.5,4.2,18.0,8.5,0.5,0.9,0.3,18.5

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "budesonide-glycopyrronium-formoterol-quality-checker",
  "utilityFolder": "BudesonideGlycopyrroniumFormoterolQualityChecker",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BGF-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "BudesonideAssay",
      "value": "160.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "GlycopyrroniumAssay",
      "value": "9.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "FormoterolAssay",
      "value": "4.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "FineParticleFraction",
      "value": "20.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "DDUDeviation",
      "value": "7.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "Moisture",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "Impurities",
      "value": "0.7",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "ValveLeak",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "ActuatorForce",
      "value": "19.0",
      "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": "BudesonideGlycopyrroniumFormoterolQualityChecker.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.