URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Bedaquiline_BedaquilineDelamanidPretomanidQCBacklog for Bedaquiline / Bedaquiline.

Domain limits and critical parameters

• • Assay of each API: 90.0–110.0%
• • Impurities of each API: ≤1.0%
• • Total Impurities: ≤2.5%
• • Dissolution: ≥85% (Q)
• • Moisture Content: ≤4.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Second-line drugs require strict quality control due to toxicity.
• BatchNumber,ProductType,BedaquilineAssayPercent,DelamanidAssayPercent,PretomanidAssayPercent,BedaquilineImpurityPercent,DelamanidImpurityPercent,PretomanidImpurityPercent,TotalImpuritiesPercent,DissolutionBedaquilinePercent,DissolutionDelamanidPercent,DissolutionPretomanidPercent,MoistureContentPercent,HeavyMetalsPPM
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% — ensures bactericidal effect
• • Impurities ≤1.0% — degradation and synthesis products
• • Total Impurities ≤2.5% — overall purity indicator
• • Dissolution ≥85% — critical for bioavailability of poorly soluble substances
• • Moisture Content ≤4.0% — drug stability
• • Heavy Metals ≤20 ppm — safety
• • Individual impurity control for each component
• • Dissolution testing for all active substances
• Critical parameters:

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductType,BedaquilineAssayPercent,DelamanidAssayPercent,PretomanidAssayPercent,BedaquilineImpurityPercent,DelamanidImpurityPercent,PretomanidImpurityPercent,TotalImpuritiesPercent,DissolutionBedaquilinePercent,DissolutionDelamanidPercent,DissolutionPretomanidPercent,MoistureContentPercent,HeavyMetalsPPM
BDP-2026-001,BDP,100.5,99.8,100.2,0.4,0.3,0.5,1.5,92.0,94.0,93.5,2.5,5.0
BDQ-2026-001,BDQ,101.0,0.0,0.0,0.5,0.0,0.0,0.6,95.0,0.0,0.0,2.0,4.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "bedaquiline-bedaquiline-delamanid-pretomanid-qc-backlog",
  "utilityFolder": "Bedaquiline_BedaquilineDelamanidPretomanidQCBacklog",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BDP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductType",
      "value": "BDP",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "BedaquilineAssayPercent",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "DelamanidAssayPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "PretomanidAssayPercent",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "BedaquilineImpurityPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DelamanidImpurityPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "PretomanidImpurityPercent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "DissolutionBedaquilinePercent",
      "value": "92.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "DissolutionDelamanidPercent",
      "value": "94.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "DissolutionPretomanidPercent",
      "value": "93.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-013"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-014"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "Bedaquiline_BedaquilineDelamanidPretomanidQCBacklog.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.