URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AtazanavirRitonavir_BoostedProteaseInhibitorFDCQualityChecker for Atazanavir/Ritonavir Boosted Protease Inhibitor FDC Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of atazanavir and ritonavir combination:
• • Atazanavir Assay: 90.0–110.0%
• • Ritonavir Assay: 90.0–110.0%
• • Atazanavir Impurities: ≤1.0%
• • Ritonavir Impurities: ≤1.0%
• • Total Impurities: ≤2.0%
• • Dissolution of each component: ≥85% (Q)
• • Moisture Content: ≤5.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Ritonavir is used as a pharmacokinetic booster (CYP3A4 inhibitor).
• BatchNumber,AtazanavirAssayPercent,RitonavirAssayPercent,AtazanavirImpurityPercent,RitonavirImpurityPercent,TotalImpuritiesPercent,DissolutionAtazanavirPercent,DissolutionRitonavirPercent,MoistureContentPercent,HeavyMetalsPPM
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures therapeutic efficacy
• • Impurities ≤1.0% for each component — degradation and synthesis products
• • Total Impurities ≤2.0% — overall purity indicator of combination
• • Dissolution ≥85% for each component — ensures bioavailability
• • Moisture Content ≤5.0% — drug stability
• • Heavy Metals ≤20 ppm — drug safety

URS — User Requirements Specification

input.csv contract

BatchNumber,AtazanavirAssayPercent,RitonavirAssayPercent,AtazanavirImpurityPercent,RitonavirImpurityPercent,TotalImpuritiesPercent,DissolutionAtazanavirPercent,DissolutionRitonavirPercent,MoistureContentPercent,HeavyMetalsPPM
ATV-RTV-2026-001,100.5,99.8,0.4,0.3,0.9,92.0,94.5,3.2,6.0
ATV-RTV-2026-002,98.0,101.2,0.6,0.5,1.3,89.0,91.0,4.1,9.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "atazanavir-ritonavir-boosted-protease-inhibitor-fdc-quality-checker",
  "utilityFolder": "AtazanavirRitonavir_BoostedProteaseInhibitorFDCQualityChecker",
  "package": "Biopharmaceuticals Extended QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ATV-RTV-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AtazanavirAssayPercent",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "RitonavirAssayPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "AtazanavirImpurityPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "RitonavirImpurityPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "0.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DissolutionAtazanavirPercent",
      "value": "92.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "DissolutionRitonavirPercent",
      "value": "94.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "3.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "6.0",
      "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": "AtazanavirRitonavir_BoostedProteaseInhibitorFDCQualityChecker.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.