The FDA is now saying, in essence, set up a process for risk assessment and worry about the things worth worrying about. That's according to the JETT Consortium's presentation in New York City at Interphex. JETT, the Joint Equipment Transition Team, was established to improve communications between users and suppliers to more effectively meet validation requirements. JETT is an ISPE special interest group of GAMP Americas.
Risk management can help prioritize resources, implement a new process or system, right-size the validation of a system, remediate existing systems, and conduct process improvement. Risk assessment may go beyond FDA issues and tackle EPA or OSHA problems as well, according to the presenters, Terry Petro of Bosch Packaging Technology and Eli Lilly and Co.'s Gary Lynch.
While risk assessment can focus on other areas such as operator safety, financial viability, and data integrity, the JETT Risk Management Model concentrates on product safety, quality, and efficacy. The model provides a context for making proactive decisions by examining and evaluating risk; controlling risk by avoidance, reduction, or automation; and finally, understanding that some residual risk will always remain. [HCP]
By Jim Chrzan, Publisher