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Cleaning Validation Glossary

Cleaning Validation (CV)

Documented evidence of consistent residue removal during cleaning

Cleaning validation is defined in PDA Technical Report 29, Points to Consider for Cleaning Validation, as "Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle". Cleaning validation is a multi-step process that leverages cleanability studies to create a cleaning recipe that removes residues to below acceptance criteria consistently. Those acceptance criteria are calculated using health based limits or, in the case of intermediate manufacturing, industry standards. Cleaning validation documents the cleaning results from three consecutive batches of a single product to determine the effectiveness of the cleaning process, conclude the critical cleaning parameters used during cleaning, and reccomend a monitoring frequency for the cleaning process. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients includes setions detailing what is required during cleaning validation.

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