Cleaning Validation in pharmaceutical manufacturing is the documented process of proving and recording the efficacy of cleaning procedures in eliminating residues, contaminants, and microbial contaminants from equipment, surfaces, or areas in contact with products. This process is essential to prevent cross-contamination and guarantee product quality, safety, and regulatory compliance. Cleaning validation encompasses the development of specific cleaning protocols, conducting comprehensive validation studies, and performing analytical testing to confirm the cleanliness and suitability of equipment or surfaces post-cleaning, thereby ensuring that all manufacturing environments meet stringent standards for product safety and efficacy.
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