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Cleaning Validation Glossary


Departures from standards

Deviation is defined in ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients as "Departure from an approved instruction or establiashed standard". There are numberous causes for a deviation to be initiated such as a failure to meet acceptance criteria, passing a failing result which was detected upon review, failure to follow a written procedure, usage of expired material, etc. The deviation process includes an investigation to determine both the impact and root cause of what had occured in addition to a plan which contains corrective and preventive actions (CAPAs) in order to remedy any issues that had occured as a result of the deviation and prevent future problems from occuring. ICH Q9 Guideline on Quality Risk Management offers approaches to handle deviations and other quality related risks.

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