URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of CagrilintideSemaglutide_ObesityCombinationPipelineWatcher for Cagrilintide/Semaglutide Obesity Combination Pipeline Watcher.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of amylin and GLP-1 analog combination:
• • Cagrilintide Assay: 90.0–110.0%
• • Semaglutide Assay: 90.0–110.0%
• • Impurities of each component: ≤1.0%
• • Total Impurities: ≤2.0%
• • Subvisible Particles: ≤6000 per mL
• • Endotoxins: ≤0.5 EU/mg
• ⚠️ CRITICAL: Peptide products are prone to aggregation. Particle and osmolality control is important.
• BatchNumber,CagrilintideAssay,SemaglutideAssay,CagrilintideImp,SemaglutideImp,TotalImp,Osmolality,pH,Particles,Endotoxins
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures therapeutic effect
• • Impurities ≤1.0% for each component — degradation products (deamidation, oxidation)
• • Total Impurities ≤2.0% — overall purity indicator
• • pH 7.0–8.5 — peptide stability and injection comfort
• • Subvisible Particles ≤6000 per mL — protein aggregation control
• • Endotoxins ≤0.5 EU/mg — injectable product safety
• • Individual impurity control considering peptide degradation specifics
• • Osmolality and pH control as stability and tolerability factors

URS — User Requirements Specification

input.csv contract

BatchNumber,CagrilintideAssay,SemaglutideAssay,CagrilintideImp,SemaglutideImp,TotalImp,Osmolality,pH,Particles,Endotoxins
CS-2026-001,100.2,99.8,0.4,0.3,0.8,300.0,7.8,150.0,0.1
CS-2026-002,98.5,101.0,0.6,0.5,1.2,310.0,7.6,200.0,0.2

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "cagrilintide-semaglutide-obesity-combination-pipeline-watcher",
  "utilityFolder": "CagrilintideSemaglutide_ObesityCombinationPipelineWatcher",
  "package": "Diabetes QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "CS-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "CagrilintideAssay",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "SemaglutideAssay",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "CagrilintideImp",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "SemaglutideImp",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TotalImp",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "Osmolality",
      "value": "300.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "pH",
      "value": "7.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "Particles",
      "value": "150.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "Endotoxins",
      "value": "0.1",
      "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": "CagrilintideSemaglutide_ObesityCombinationPipelineWatcher.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.