Tag Archives: E.U.

Serialization Mistake #1: Printing On Your Outsert

istock_83993805_smallerThere are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations.  One of these is to print the unique identifier on the outsert attached to their packaging.  An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug.  It contains Continue reading Serialization Mistake #1: Printing On Your Outsert

Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers

Somethings Gotta GiveEverywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time.  This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers