Cross-contamination must be avoided in the pharmaceutical industry and a successful cleaning ensures that patients are not put at risk due to cross contamination. Cleaning is a process and therefore it should be validated.
Cleaning validation is a highly regulated and complex process and includes a multistep assessment to cover a variety of aspects, form initial design up to field execution and monitoring. The process passes through risk-based assessments, according to Quality Risk Management principles and involves a multi-disciplinary team.
CV takes part of risk mitigation actions since it plays an important role in reducing the possibility of product cross-contamination and product carry-over in multi-purpose manufacturing equipment.
Other than EU-GMP Annex 15, the latest version of Annex 1 also emphasizes the importance of a cleaning program. The FDA guideline on Process Validation lifecycle approach is applied also to cleaning validation.
This webinar will sum-up the key steps of the lifecycle approach with the intention to help a compliant and successful cleaning validation process.