CE_Recombinant_Protein_Purity

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface, validation behaviour and expected output of CE_Recombinant_Protein_Purity. The document is intended to reside inside the utility folder together with input.csv and the description file. Expected executable: CE_Recombinant_Protein_Purity.exe.

Scope

Domain limits and critical parameters

• • Main Band ≥95.0%
• • High Molecular Weight Impurities (Aggregates) ≤2.0%
• • Low Molecular Weight Impurities (Fragments) ≤3.0%
• • Total Impurities ≤5.0%
• • Peak Resolution ≥1.5
• ⚠️ CRITICAL: Protein aggregates can trigger immune responses.
• CE_Recombinant_Protein_Purity.exe input.csv output.json → evaluate your data
• BatchNumber,ProteinName,MainBandPercent,HMW_Impurities_Percent,LMW_Impurities_Percent,Total_Impurities_Percent,Resolution
• • Main Band: Target protein with correct molecular weight.
• • High Molecular Weight Impurities (HMW): Dimers, oligomers, and aggregates. Critical for safety due to immunogenicity risk.
• • Low Molecular Weight Impurities (LMW): Protein fragments resulting from hydrolysis or incomplete synthesis.
• • The method provides high reproducibility and accurate quantification of impurities compared to gel staining.
• ⚠️ CRITICAL:
• • Main substance purity ≥95.0% (for highly purified products often ≥98-99%).
• • Aggregate content is strictly limited (≤2.0%) due to allergy risk.
• • Resolution between main peak and impurities must be sufficient for integration (≥1.5).

Pharmacopoeial and regulatory references found in the description

Production data flow

URS — User Requirements Specification

input.csv contract

BatchNumber,ProteinName,MainBandPercent,HMW_Impurities_Percent,LMW_Impurities_Percent,Total_Impurities_Percent,Resolution
PROT-REC-2026-001,Recombinant Human Insulin,97.5,0.5,1.2,2.5,2.5
PROT-FAIL-2026-002,rHu_Growth_Hormone,92.0,3.5,2.0,6.5,1.2

Input validation rules

FS — Functional Specification

Example output.json structure

{
  "utilityId": "ce-recombinant-protein-purity",
  "utilityName": "CE_Recombinant_Protein_Purity",
  "object": "CE Recombinant Protein Purity",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "recordCount": 2,
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "PROT-REC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-001"
    },
    {
      "parameter": "ProteinName",
      "value": "Recombinant Human Insulin",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-002"
    },
    {
      "parameter": "MainBandPercent",
      "value": "97.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-003"
    },
    {
      "parameter": "HMW_Impurities_Percent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-004"
    },
    {
      "parameter": "LMW_Impurities_Percent",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-005"
    },
    {
      "parameter": "Total_Impurities_Percent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-006"
    },
    {
      "parameter": "Resolution",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result",
      "ruleReference": "VR-007"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "metadata": {
    "executionMode": "CLI",
    "interface": "CSV to JSON",
    "documentationFile": "CE_Recombinant_Protein_Purity.documentation.html"
  }
}

Traceability matrix URS → FS → OQ/PQ

OQ/PQ test scenarios

QA/QC, CSV/CSA and change control

• Do not rename columns without updating the validator, test set and documentation.
• Retain input.csv, output.json, executable version, checksum and a copy of the documentation.
• Before production use, perform IQ/OQ/PQ or equivalent risk-based CSV/CSA verification.
• Critical limits shall be approved by the process owner and verified against the registration dossier, pharmacopoeia and local SOPs.
• Any change to rules, thresholds or status interpretation shall go through change control and regression testing.