Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Qualification/validation can be defined as “establishing documented evidence which provides a high degree of assurance that specific equipment procured will ...

In the pharmaceutical and biotechnology sector, validation is a mandated practice integral to the entire drug development process, particularly in the context of computerized systems and manufacturing ...