PDA Letter | July 2018 | byVito Pirrera and John Jordon
You must serialize if you are a pharmaceutical manufacturer or packager. You have no choice.
Each saleable unit of your product (think carton, tray, and individual bottles) and homogeneous shipper (case) must be printed with a unique identifier. In a measure to curb drug counterfeiting, every product must be trackable and traceable from manufacturing to medicine cabinet. That is the rule. And, thanks to the U.S. FDA’s recent one-year extension in enforcement of the Drug Supply Chain Security Act (DSCSA), the rule takes effect November 27, 2018.
As necessary as the law is, it almost certainly will affect your productivity: adding processes to any system rarely speeds it up at the outset. For some companies, serialization will be an inconvenience; for others, it will be a nightmare. But one strategy could help companies understand serialization-driven productivity loss, reclaim their accustomed level of performance and emerge from implementing serialization with better performance that ever – overall equipment effectiveness (OEE)…read more