A unique and practical solution for meeting the November 2018 DSCSA mandate.
As trends in counterfeiting and product diversion spiral, Ropack Pharma Solutions provides an industry-leading serialization system that serializes beyond the unit level to the bundle, case and pallet levels, compliant with the USA FDA Drug Supply Chain Security Act (DSCSA).
International Serialization Hub
Ropack Pharma Solutions provides serialization, using TraceLink technology, through an innovative option: an International Serialization Hub. The hub allows pharmaceutical organizations – or their contract packagers – to outsource serialization to RPS without the added costs and complexities of setting up their own system. Organizations send packaged products to the RPS hub for serialization and distribution, allowing the organizations to maintain their primary contract partners.
Your packaged pharmaceutical products are sent to our hub in Montreal, Canada – or we can package and serialize your products.
We serialize to your specifications, compliant with DSCSA.
Your newly serialized products are shipped to your distribution network around the globe or to your warehouse.
• Maintain your core manufacturing and packaging suppliers
• Generate significant labor and capital cost savings
• Meet the DSCSA mandate deadline of November 2018
• Product/package serialization to the unit, bundle, case and pallet levels
• Product/package aggregation into bundles, cases and pallets
• Custom product/package design including artwork customization and barcode design
• 35 Class 100000 clean rooms within facilities totaling 241,000 sq. ft.
• cGMP cold storage capabilities up to 400 pallets
When you outsource your serialization to Ropack Pharma Solutions, you can be assured of a serialized supply chain that is proficient, verified and ready to safeguard your pharmaceutical product – and the prescribers and patients who depend on it.
What is Serialization and why do we need it?
SERIALIZATION is the association of a product/package (single saleable unit) with a unique, traceable serial number identifier.
AGGREGATION is physically combining a product/package from the unit level into bundles, cases and pallets for distribution. As the product/package is combined, the serial number of the aggregated unit (parent) is associated with the multiple serial numbers of the child units contained within it.
TRACK AND TRACE – Tracking a product is the ability for a pharmaceutical business to locate products within the pharmaceutical distribution supply chain. Tracing a product is the ability to identify each location the product is being moved from and to within the supply chain, including ‘Transaction Information’ — information about the product’s movement.
The U.S. FDA Drug Supply Chain Security Act (DSCSA) mandates that all manufacturers of drug products mark products/packages with a ‘Product Identifier’ by November 2018. For drugs destined for the U.S. market, the ‘Product Identifier’ includes a standardized barcode, serial number, lot number and expiration date. Serialization for the European Union is required for February 2019.