URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AbacavirDolutegravirLamivudineQualityChecker for Abacavir/Dolutegravir/Lamivudine Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of abacavir, dolutegravir, and lamivudine combination:
• • Assay of each component: 90.0–110.0% of label claim
• • Impurities of each component: ≤1.0%
• • Total Impurities: ≤2.0%
• • Dissolution of each component: ≥85% (Q)
• • Moisture Content: ≤5.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Violation of content of any of the three components reduces HIV therapy efficacy.
• BatchNumber,AbacavirAssay,DolutegravirAssay,LamivudineAssay,AbacavirImpurity,DolutegravirImpurity,LamivudineImpurity,TotalImpurities,DissolutionAbacavir,DissolutionDolutegravir,DissolutionLamivudine,MoistureContent,HeavyMetalsPPM
• • Requires strict control of content of all three components
• ⚠️ 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% — critical for stability of all three active substances
• • Heavy Metals ≤20 ppm — drug safety
• • Individual impurity control for each component

URS — User Requirements Specification

input.csv contract

BatchNumber,AbacavirAssay,DolutegravirAssay,LamivudineAssay,AbacavirImpurity,DolutegravirImpurity,LamivudineImpurity,TotalImpurities,DissolutionAbacavir,DissolutionDolutegravir,DissolutionLamivudine,MoistureContent,HeavyMetalsPPM
ADL-2026-001,100.5,99.8,101.2,0.3,0.2,0.4,0.9,92.0,90.5,94.0,3.5,8.0
ADL-2026-002,98.0,102.5,97.5,0.5,0.3,0.6,1.4,88.0,87.5,89.0,4.2,12.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "abacavir-dolutegravir-lamivudine-quality-checker",
  "utilityFolder": "AbacavirDolutegravirLamivudineQualityChecker",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ADL-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AbacavirAssay",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "DolutegravirAssay",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "LamivudineAssay",
      "value": "101.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "AbacavirImpurity",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "DolutegravirImpurity",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "LamivudineImpurity",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "TotalImpurities",
      "value": "0.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "DissolutionAbacavir",
      "value": "92.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "DissolutionDolutegravir",
      "value": "90.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "DissolutionLamivudine",
      "value": "94.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "MoistureContent",
      "value": "3.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "8.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-013"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "AbacavirDolutegravirLamivudineQualityChecker.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.