De-mystifying Serialization and Track and Trace

There are countless articles available on the internet now on Serialization and Track and Trace. California has enacted laws that require compliance starting in 2015. The FDA is now working on creating national legislation that will include some form of Serialization and/or Track and Trace.

To put these programs into simple terms, Serialization is the numbering in sequence (or serial numbers) on individual units of sale of controlled substances (i.e. pharmaceuticals). This allows the manufacturer to be able to tell by the serialization code exactly when and where that unit was produced down to the individual batch. Track and Trace takes it a good bit further. Track and Trace requires the manufacturer to create a database that tracks the product from the raw materials state, through creation of consumable unit, individual packaging, aggregate packaging, shipping, warehousing, re-distribution, to final sale (to end consumer) and/or use (in hospital).

For ‘The rest of this story’, see my next blog.

The author, Marge Bonura, is the Director of Sales & Marketing for New England Machinery, Inc. (NEM). NEM is a leading packaging machinery manufacturer of bottle unscramblers, cappers, orienters, retorquers, lidders, pluggers, pump sorter/placers, scoop feeders, hopper elevators and much more. The company has been in business since 1974 selling to the food, beverage, pharmaceutical, personal care, chemical, household products, automotive and other industries. For more information on NEM, visit their website at www.neminc.com.