Cleaning Validation

It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.

What is cleaning validation and where does it fall in the life cycle validation scheme? How can an automated washing system be validated? This article provides insights that may help answer these questions.

This article presents the standards and guidelines typically used by manufacturers to design and build GMP washers and sterilizers. It describes the characteristics that differentiate GMP from regular laboratory equipment.