Changes for the Pharmaceutical Industry – Part II

What is required of setting up a Serialization/Track and Trace system? For the serialization portion the pharmaceutical manufacturer will need to determine how they want to set up the Serial ID numbers based partly on required formats and standards and incorporating their own customization. They will then need to acquire the software capable of generating and tracking the serial codes. The software will need to interface with printers, vision systems and other equipment.

The next step will include creating and tracking the parent-child aggregation of the packaging. For example, when a single bottle of pills is boxed and placed in a carton with other single bottles of pills. Those individual serial codes must be included as the ‘children’ of the case/carton which will have a ‘parent’ code. The cases/cartons will then need to be included under the pallet’s ‘parent’ code.

As the product is fully coded and ready to leave the manufacturing plant, the product codes will need to be registered as to the date and time they left the facility and where and when they are delivered to their next stop. As the product travels through the supply chain, it must be ‘received’ at each stop and the data sent back to the originating facility. When it finally reaches the end user, (a consumer or hospital dispensary), the individual who is to consume or dispense the individual dose, should be able to scan the serial code and verify that this dose is traceable back to its inception at the original production plant.

What is the value of Serialization/Track and Trace? Read my next blog to find out.

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.