In year 2018, we’ll look back at 2015 and reminisce about the simplicity of lot controlled manufacturing. Under today’s lot control standards, when a lot of 50,000 is produced and released to inventory, one massive inventory record is created which contains all of the information on the lot, inventory status, and lot quantity.
In 2018, manufacturing will focus on creating and managing data just as much as making the actual products themselves. The data I am referring to is of course the serialization data. When the same lot is released to inventory with serial control, 50,000 serialization records are created, each of which contains a unique serial number and its own unique inventory status. Moving forward into the future, the data attributes of a product will be just as important as the physical attributes of a product. The very nature of serialization is to use the serial numbers as the authentication measure, verifying the legitimacy of drug products and removing counterfeits from circulation. If the serial number of a unit is verified as correct, it is authentic. Otherwise, it is a suspect, illegitimate, or counterfeit product.
Products with good quality but bad data simply cannot be introduced to commerce. If drug products without proper serialization data are released into commerce, they must be recalled when the mistake is discovered. Because of the absolutely crucial nature of data quality, I highly recommend companies invest in master data management and serialization data management to ensure data integrity and accuracy. One adverse event is one too many. Don’t let poor data quality be the culprit of your next recall.