BatchReleaseJsonBuilder

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BatchReleaseJsonBuilder for Batch Release Json Builder.

Domain limits and critical parameters

• ℹ️ Utility performs automated assembly and validation of data for the Certificate of Analysis according to GMP Annex 16 and 21 CFR Part 211.194 requirements:
• • Specification Verification: Comparison of obtained values with approved limits (Numeric limits and Textual criteria).
• • Qualified Person (QP): Tool for rapid review of critical parameters.
• This is critically important for adhering to Data Integrity (ALCOA+) principles and accelerating product release cycles.
• ⚠️ CRITICAL:
• • Data Completeness: All mandatory tests (Monographed tests) must be present in the file.
• • Units of Measure: Must strictly comply with pharmacopoeial monographs.
• • Specification Versioning: Ensure current limits are used.
• Critical parameters:
• • Assay/Potency: Active pharmaceutical ingredient
• 2. Exception Review: Even with "Compliant" status, QP must check for closed deviations.
• 4. Security: Access to utility must be restricted to authorized personnel.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,TestName,NumericResult,StringResult,Unit,SpecLower,SpecUpper,SpecText,MfgDate,ExpDate
BATCH-2026-API-001,Paracetamol Tablets 500mg,Assay,99.8,,%,98.0,102.0,,2026-01-15,2028-01-15
BATCH-2026-API-001,Paracetamol Tablets 500mg,Impurity_A,0.05,,%,0.0,0.10,,2026-01-15,2028-01-15
BATCH-2026-API-001,Paracetamol Tablets 500mg,Dissolution_Q,85,,%,80,,,2026-01-15,2028-01-15

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "batchreleasejsonbuilder",
  "utilityFolder": "BatchReleaseJsonBuilder",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BATCH-2026-API-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Paracetamol Tablets 500mg",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "TestName",
      "value": "Assay",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "NumericResult",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "StringResult",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "Unit",
      "value": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "SpecLower",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "SpecUpper",
      "value": "102.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "SpecText",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MfgDate",
      "value": "2026-01-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "ExpDate",
      "value": "2028-01-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "BatchReleaseJsonBuilder.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.