Serialization has been a hot topic in the pharmaceutical industry and will continue to pick up speed as the DSCSA deadlines continue to rollout. Next up: November 2017 when all pharmaceutical manufacturers must serialize down to the unit level.
Consider this: A contract manufacturer of aspirin needs to produce one pallet of product for their customer. With the new FDA rules, a barcode placed on that pallet will contain data of each individual bottle and case placed on the pallet. So, if there are 24 serialized bottles of aspirin in each case, and 100 serialized cases on the pallet, then that pallet has at least 2,400 unique pieces of data that needs to be tracked and traced.
To deploy proper serialization strategies without sacrificing production efficiencies, manufacturers need to evaluate solutions that deliver automation within a flexible environment.
The good news: We’ve got you covered!
This summer, we introduced our AutoFinisher which is a significant part of Deacom’s ERP system for pharma serialization. The functions provided by the AutoFinisher automatically generate serial numbers with specifications defined in the core ERP system. It then sends the information down to production equipment to be applied to units, cases, and pallets. Throughout the entire process, the AutoFinsisher provides real-time reporting in DEACOM ERP. Should a recall occur, the detailed records kept in DEACOM helps manufacturers quickly trace it back to the individual unit, case, and pallet in question.
While right now the FDA requires serialization at only three levels, DEACOM can add an unlimited amount of levels if customers require something different. No matter how many there are, Advanced Shipment Notices (ASN) can be automatically generated upon completion with data from all serialized levels. Shared with the FDA and customers, this document is critical to enhancing recall reporting.
A big concern of pharmaceutical companies as they look to implement these new procedures is how to be compliant with 21 CFR Part 11. By taking extra steps, like tracking and storing commissioned and decommissioned serialized numbers for FDA audits, Deacom customers can maintain this validation confidently.
For more information about how Deacom handles serialization for pharmaceutical companies, click here.