ABSTRACT
The efforts for validation and qualification should be balanced against the benefits, which means the amount of work should be in line with the problems that can occur if processes and systems are not fully validated. The mechanism for this is risk assessment and the definition of the extent of validation, according to the risk, that a specific process or system can have on product quality and, ultimately, consumer safety. The risk-based approach should enhance the laboratory’s ability to focus on identifying and controlling critical functions that affect product quality, so that less or no time is spent on systems and functions that have little or no impact on product quality and consumer safety.
