PotencyAssayTrendChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of PotencyAssayTrendChecker for Potency Assay Trend Checker.

Domain limits and critical parameters

• Potency Assay Trend Checker — Statistical Potency Trend Analysis (SPC)
• ℹ️ Utility performs statistical analysis of historical potency data for medicinal products in accordance with Statistical Process Control (SPC) principles and ICH Q10 / VICH GL requirements:
• • Shewhart Control Charts: Automatic calculation of mean, standard deviation (SD), upper and lower control limits (UCL/LCL ±3SD) and warning limits (±2SD).
• • Westgard Rules: Algorithmic check of data sequences for systematic errors (mean shifts, drift, out-of-control limits).
• PotencyAssayTrendChecker.exe → demo mode (console output)
• PotencyAssayTrendChecker.exe input.csv output.json → evaluate your data
• BatchNumber,ManufacturingDate,PotencyResult_IU_per_dose,TargetPotency_IU_per_dose
• Trend monitoring is a mandatory element of the Pharmaceutical Quality System (PQS) according to ICH Q10 and Stage 3 of Process Validation (Continued Process Verification).
• Gradual change in activity may indicate raw material degradation, equipment wear, or uncontrolled drift of Critical Process Parameters (CPP).
• ⚠️ CRITICAL:
• • Out of 3SD: Single point beyond control limit indicates Special Cause Variation requiring investigation.
• • Support for ICH Q10 (Pharmaceutical Quality System) and VICH GL requirements
• Critical parameters:
• 4. Documentation: JSON reports must be saved as objective evidence of trend monitoring.
• ⚠️ Note: Unlike batch-by-batch specification compliance control (Pass/Fail), this tool is designed to assess the State of Control of the manufacturing process dynamics, which is a requirement of modern GMP standards.

URS — User Requirements Specification

input.csv contract

BatchNumber,ManufacturingDate,PotencyResult_IU_per_dose,TargetPotency_IU_per_dose
VAC-2025-001,2025-01-15,102.5,100.0
VAC-2025-002,2025-02-10,101.8,100.0
VAC-2025-003,2025-03-05,103.1,100.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "potencyassaytrendchecker",
  "utilityFolder": "PotencyAssayTrendChecker",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "VAC-2025-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ManufacturingDate",
      "value": "2025-01-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "PotencyResult_IU_per_dose",
      "value": "102.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "TargetPotency_IU_per_dose",
      "value": "100.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "PotencyAssayTrendChecker.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.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.