Cleaning Validation of Pharmaceutical Equipment
Cleaning Validation of Pharmaceutical Equipment
Cleaning Validation is a documented process that provides a high degree of assurance that equipment used in the manufacturing of pharmaceutical products is consistently cleaned to predetermined and acceptable limits. It ensures that residues of active pharmaceutical ingredients (APIs), cleaning agents, and microbial contaminants are removed to a level that does not affect product quality or patient safety.
Key Aspects of Cleaning Validation:
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Regulatory Requirement: Mandated by FDA, EMA, WHO, and other global agencies.
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Objective: Prevent cross-contamination and ensure patient safety.
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Approach: Risk-based, product-specific, or worst-case approach.
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Acceptance Criteria: Established based on health-based exposure limits (HBEL), maximum allowable carryover (MACO), and visually clean criteria.
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Methods of Testing: Swab sampling, rinse sampling, and direct inspection.
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Documentation: Includes validation protocols, reports, analytical methods, and revalidation strategy.
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Lifecycle Management: Continuous verification, periodic review, and updates as per process changes.
Proper cleaning validation is essential for maintaining Good Manufacturing Practice (GMP) compliance and ensuring drug product safety and efficacy.
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