The Pharmaceutical Industry Confronts Approaching Deadlines
By Tom Egan, vice president, Industry Services, PMMI
Keeping up with regulatory requirements has kept the pharmaceutical industry at the forefront of track-and-trace technologies for years. Now, those regulations are set to get even more stringent on a global scale. With some key deadlines on the horizon, pharmaceutical manufacturers and their OEM suppliers are stepping up their serialization strategies.
The goal of serialization, of course, is to prevent counterfeit or adulterated drugs from entering the supply chain. It provides the potential to trace a product throughout its entire lifecycle from production, distribution, and all the way to the hands of the consumer. This requires an investment in automation as well as in technologies such as vision and inspection systems.
The Drug Quality and Security Act (H.R. 3204), and Title II of the law, the Drug Supply Chain Security Act, require that by November 2017 manufacturers put unique product identifiers on prescription drug packages. This includes a National Drug Code (NDC), a serial number, a lot number and an expiration date. If there is a suspect product in the supply chain, manufacturers will need to be able to verify the product’s standardized numerical identifier (SNI), which consists of the NDC and a serial number. Repackagers will be subject to the same requirements in 2018, and wholesale distributors and dispersers will need to follow suit in 2019 and 2020 respectively. Enhanced product tracing at the package-level will be required by 2023.
These are just the U.S. regulations. Other countries and regions have evolving track-and-trace requirements, and these efforts are not always in harmony with each other. It is no wonder serialization has been top of mind for the pharmaceutical industry. Manufacturers and their suppliers have been striving to implement hardware and software methodologies to serialize everything from saleable units, to cartons, cases, pallets and shiploads.
Aggregation without Aggravation
Some manufacturers are stepping up their serialization efforts by venturing into the world of aggregation. Aggregation adds a level of hierarchy into serialization by creating “child-parent” relationships between individual units and packaging containers. An example is a carton (child) placed within a case (parent). A receiver simply scans the bar code of the case and is able to determine information about the cartons in the case without opening it up.
While aggregation can simplify logistics and add transparency to the supply chain, adopting aggregation requires an investment in new technologies, resources and training. The “parent-child” aggregated relationships need to be managed throughout all phases of production, packaging and warehousing. Any disruptions need to be documented, for example if a product from a carton is taken off a pallet for sampling.
Although it is not mandated currently for pharmaceuticals in the U.S., other countries have already adopted elements of aggregation. In Brazil aggregation is required between transport containers and saleable units, and in Turkey between unit levels and cases.
As 2017 draws near, manufacturers are realizing they cannot afford to put off serialization efforts—let alone aggregation—any longer. It is not just drug makers who are responding to global regulatory pressures but also wholesale distributors. McKesson, for example, recently started requiring that serialized item-level products from its suppliers be aggregated to upper level packaging.
Find it at Pharma EXPO
For pharmaceutical companies that have not yet put a serialization strategy in place, now is a good time to start. A number of vendors are offering solutions to help drug makers meet serialization requirements. Collaborations between equipment and software manufacturers are becoming more common to help meet present and future serialization and aggregation requirements.
Attendees at this year’s Pharma EXPO (McCormick Place, Chicago; Nov. 6 – 9, 2016) will have an opportunity to see the latest technologies in serialization and aggregation. The event is co-produced by PMMI, The Association for Processing and Packaging Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will be co-located with PACK EXPO International 2016. Together, the shows will feature more than 2,500 exhibitors and draw 50,000 attendees.
To register for Pharma EXPO, visit www.pharmaexpo.com. Registration grants attendees access to both Pharma EXPO and PACK EXPO International 2016.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components and materials for processing and packaging. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara and ProFood Tech, launching in April 2017. PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market and industry trends to support members’ growth strategies, and actively connect the supply chain throughout the year. Learn more at PACKEXPO.com, PMMIMediaGroup.com and PMMI.org.
 Source: FDA, "Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview of Product Tracing Requirements," (powerpoint), Sept. 2015. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/UCM464907.pdf
 Source: “Aggregation 101…”, Tracelink http://www.tracelink.com/resources/aggregation-what-it-is-who-requires-it-what-it-means-for-supply-chain
 Source: Cao, R., "Wholesale Distributors Deliver Clarity Around Serialization and Aggregation Requirements," LSPediA, Feb. 17, 2016. http://lspedia.com/wholesale-distributors-deliver-clarity-around-serialization-and-aggregation-requirements