FDA Watch : Commissioning - A Risk-based Approach

An excerpt from Institute of Validation Technology.

The Institute of Validation Technology indicates that the Commissioning of systems and equipment within the pharmaceutical industry is quickly becoming a stable endeavor. While the intent of the practice was to cut the cost associated with validation, it has quickly become entangled in the web of Risk Assessment and Management.

Every system and piece of equipment utilized in the pharmaceutical and medical device industries is subject to a commissioning exercise. Commissioning using a risk assessment approach is best applied to new equipment and system installations.

Commissioning is now being viewed as an active part of the qualification process. It is imperative that it be performed in a structured, analytical and compliant way. Current FDA regulations do not mandate that commissioning or risk assessments be performed, but it is the trend and the latter may be the justification for the prior.

Many questions arise when one considers the application of risk assessment when conducting Commissioning. Among these are:

• When do we apply risk assessment?
• What thinking and planning are involved?
• What tools might be available to conduct this activity?
• Will the FDA care?
• What does it do for me or my project?
• How are risk assessment and commissioning related?
• What is the current thinking of the FDA regarding Commissioning and Risk Assessment?
• Where do we start with risk assessment?
• How do these concepts affect the final outcome of qualification and validation?