Pharmaceutics International, Inc. (Pii), a CDMO headquartered in Hunt Valley, MD, has implemented its Serialization and Aggregation process to support current as well as future commercial production operations, ahead of the deadlines outlined by the FDA and in the DSCSA. Pii has successfully serialized, aggregated and shipped multiple lots of various products. All required products will be fully serialized and aggregated prior to the November 2018 deadline for serialization.
 
The track and trace system allows for application to cartons and bottles for all dosage forms including tablets, soft and hard gelatin capsules, powders, and injectable products, and allows aggregation to the case pack, shipper and pallet levels.
 
Michael Bogda, president and chief operating officer, said, “We wanted to implement a system that is accurate, efficient, versatile, cost-effective and of the appropriate capacity and size to fit our production efforts. As a CDMO, our customers’ needs are very diverse across a wide range of product types and packaging configurations.  Being able to accommodate efficient line clearance and changeovers and still meet the various levels of customer requirements required that our team find a solution that is designed for flexibility and operational functionality. We far exceeded that expectation. Pii is now positioned to be ahead of the regulatory requirements for serialization and aggregation and we are ready to provide this key service to our customers.”