Can templates simplify the validation process?

MGS Machine Corp., a packaging machinery OEM with a keen interest in pharmaceutical packaging, is developing templates to help its customers with the validation process. For example, for machines that attach an outsert, MGS provides a five-page template that explains in explicit terms how the machine works, how bad product is rejected from the line, how the machine communicates, and how it verifies that the reject really did happen. Also developing templates is the JETT (Joint Equipment Transition Team) Consortium, a special interest group of the International Society for Pharmaceutical Engineering, created to help ease the cGMP process. JETT aims to improve communication between users and suppliers of automated production and process equipment to meet validation requirements more effectively.

"JETT is looking at some of the documentation, like design requirements, and developing templates based on cGMP that have a validation checklist, or something very similar," says Dave Whittenton, Rockwell Automation's business development manager, life science. "You can just pull down the template for a bottle capper, for example."

"We invest in keeping abreast of user groups working on validation standards, and working on processes for users and suppliers to interact, like the JETT Group," says Dave Schuh, VP of sales and marketing at MGS Machine. "End users and suppliers can together hash through specifics of how to interact and develop a process flow that improves efficiency in improving equipment."

"We see a lot of user requirement specifications, and the current trend is to re-evaluate how to write a User Requirement Specification and how we can improve the URS documentation," says Whittenton. "The entire industry needs to get better at writing those, to get better at writing URS's that drive the functional specifications, and to get better on the front end so the back end is just check-box qualifications."

--By Brian Pelletier, Contributing Editor
More in Regulatory