Total Organic Carbon (TOC) methodology validation is essential to confirm the accuracy, precision, and reliability of cleaning verification in pharmaceutical manufacturing. A structured approach ensures compliance with regulatory standards and effective residue detection.
Validation Process:
Define Objectives: Identify equipment, surfaces, and critical control points for TOC analysis.
Method Selection: Choose appropriate TOC analyzers and measurement techniques suitable for the product and residue type.
Calibration and System Suitability: Perform instrument calibration, establish detection limits, and verify linearity, accuracy, and precision.
Sample Collection: Define standardized rinse or swab sampling procedures to ensure representative residue capture.
Validation Testing: Conduct repeatability, reproducibility, and recovery studies to demonstrate method reliability.
Acceptance Criteria: Establish TOC limits based on risk assessment, product potency, and regulatory guidance.
Documentation: Record procedures, results, deviations, and corrective actions to support GMP compliance and audits.
By following this structured methodology validation process, pharmaceutical manufacturers can ensure accurate TOC testing, reliable cleaning verification, and regulatory compliance, safeguarding product quality and patient safety.