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Cleaning Validation: Analytical Strategies and Practical Implementation Using Chromatographic Methods

DOI: 10.4236/ajac.2026.173006, PP. 61-82

Keywords: Analytical Cleaning Validation, MACO Limits, ICH, and FDA Guidance

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Abstract:

The cleaning validation is the most important step. Cleaning validation is a crucial aspect of pharmaceutical manufacturing to ensure that residues from previous batches do not contaminate subsequent products. This review explores the principles, regulatory requirements, analytical techniques, validation parameters, challenges, and future trends associated with cleaning validation. The focus is on ensuring compliance with Good Manufacturing Practices (GMP) while maintaining product safety and efficacy. This review paper provides a comprehensive review of analytical method cleaning validation procedures.

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