top of page
glossary-tiles_edited.jpg

Cleaning Validation Glossary

Deviations

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.

How Can We Help?

Tell us what you're looking to achieve.  We'll put our experience to work to solve your specific problem.  If you have any questions or inquiries, please do not hesitate to contact us. Our team is here to assist you and provide you with the information you need.

LI-Logo_edited.png
bottom of page