Cleaning validation is a critical component of regulatory compliance in the life sciences industry. It ensures that cleaning processes consistently remove residues, contaminants, and potential carryover from equipment surfaces to maintain product safety and efficacy. Unlike process validation for manufacturing, cleaning validation presents unique challenges, such as selecting worst-case conditions, ensuring appropriate sampling techniques, and verifying residue limits.

This video breaks down an FDA finding on cleaning equipment validation, highlighting key compliance risks and common gaps that can lead to regulatory citations. By understanding these challenges, manufacturers can develop more robust validation strategies to ensure compliance with FDA and industry standards.

Key Topics Covered:

✅ Ensuring validation assurance for cleaning equipment – Why a high degree of assurance is required and how to achieve it.

✅ Master validation plan scope and compliance gaps – The importance of properly categorizing cleaning validation within your overall validation framework.

✅ Worst-case scenario testing for robust validation – How to effectively challenge your cleaning process under worst-case conditions.

✅ Targeted sampling strategies and prerequisite testing – Best practices for residue testing, swab recovery, and method validation.

🔍 Learn how to optimize your cleaning validation approach and stay audit-ready!

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