The serialization mandate has had widespread effects across the industry. Congress passed the Drug Quality and Security Act (DQSA) on November 27, 2013, and with it Title II of the DSQA or the Drug Supply Chain Security Act (DSCSA). The DSCSA provides an outline for the track and trace of all pharmaceuticals throughout the supply chain, ensuring that quality and security are present as the drug passes from one supplier to another.1
The DSCSA includes special requirements for manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners),2 mandating that all parties who deal with a drug product are equally responsible for it and that quality is not compromised and information is not lost at any point in the many phases of the supply chain. The overall goal of the DQSA is to repel counterfeits and bolster the reliability and quality of all drugs that are sold and distributed within the United States.
Interpreting Serialization, Firm by Firm
The pharmaceutical industry was given an extension to meet the serialization deadline, as the process of fully bringing the supply chain up to date has been extensive. Certain requirements began in 2014 and will not be completed until 2023.2 The FDA has released a shorthand step-by-step guidance for all companies to confirm that they are ready for the DSCSA, in checklist form. The main tenets to ensure compliance are: “Become familiar with the law; Work with your trading partners to ensure they are familiar with the law; Provide product tracing information (manufacturers, repackagers, wholesale distributors, and dispensers); Know how to handle suspect and illegitimate product (manufacturers, repackagers, wholesale distributors, and dispensers); Confirm authorized trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers); and Report licensure (third-party logistics providers and wholesale distributors).”2 It is apparent that this is a multi-tiered process involving many layered components, especially as one supplier relates to another. The act essentially requires the unification of the supply chain on a basic level, as various companies must work together to confirm that all standards are met are on both sides.
Operation Integration
Fitting a production line with a serialization solution is no longer just an option — it is a requirement. When dealing with track and trace, a firm should not consider just the equipment but also the software that is powering the controller. Information technology is a huge part of the equipment needed for serialization, and all equipment must be compliant.3 A serialization process requires that all machinery undergo several steps, including printing and verification, aggregation of serialization information and allowing for traceability through an integrated technology system that communicates information about the product throughout the supply chain.3
When transforming a production line, a CDMO should look for machines that are device-independent and can be integrated with the control system. The control system should be able to handle the large volume of data flow needed to be processed — internal IT infrastructure must be considered in addition to the surface machinery.3
The Cost Challenge
The challenge of serialization mainly centers on cost. Of course, though the DSCSA guidelines have been established, there is no restrictive process in place. This has allowed companies to interpret and enact serialization as they see fit for their organizations. It is a fairly opened-ended process, and the method of track and trace does not necessarily have to look the same as long as all overarching goals are met –– the “how” is far less important than the outcome.
Track-and-trace requirements can mean anything for the industry, as contract manufacturing and development organizations (CDMOs), as well as packaging suppliers, have done everything from totally revamping operations, to making the minimum effort possible in order to comply with the act — there is no right or wrong approach as long as all drug product is accounted for and traceable within the supply chain. However, perhaps the main deciding factor in how an organization conforms to the serialization guidelines depends on the company budget and the equipment resources available.
The Used Equipment Solution
In order to recover costs associated with implementing track and trace, an organization will benefit from purchasing used equipment. Working with a trusted partner and highly experienced used equipment dealer, such as Federal Equipment Company, is critical when trying to initiate cost recovery while pursuing serialization. At Federal Equipment Company, we offer a wide range of reliable used machinery for purchase at a fraction of the cost of new machinery. The equipment we offer is housed in clean, climate-controlled warehouses. Given the constrained timeline for meeting the DSCSA guidelines, used equipment is a great option, as there is no lead time and it can be shipped immediately.
Serialization also demonstrates the necessity for pharmaceutical companies and CDMOs to consider their existing equipment and strategize its deployment. Federal Equipment Company makes purchasing equipment simple — all available inventory can be browsed through our website, including machinery coming from liquidation or auctions. Equipment can be searched for by keyword or browsed by category. In addition to this, our sales team is available to assist, helping you find whatever you are looking for.
Likewise, if you are ready to sell any of your equipment, Federal Equipment Company is a trusted partner you can rely on. Our inventory is constantly updated and replenished, as we have partnerships with major organizations like Pfizer, that supply us with surplus assets through the asset management programs we run on their behalf. This means you are guaranteed to be in trustworthy hands whether buying or selling equipment.
The Right Equipment
We stand out from other equipment suppliers because our broad range of reliable equipment are from reputable sources and have been manufactured by industry-leading OEMs. Our inventory is available on-site, ready for inspection and sold by experts who possess a wide-ranging knowledge of both the equipment and industry. In the case of solid-dose pharmaceutical equipment, we are partnered with the experienced manufacturing training and troubleshooting experts at Techceuticals.
Ultimately, from serialization to the next great manufacturing shift, Federal Equipment Company is here to support our customers with the right equipment.
References
- ”Drug Supply Chain Security Act (DSCSA).” U.S. Food and Drug Administration. 27 Nov. 2013. Web.
- “Are you ready for the Drug Supply Chain Security Act?” U.S. Food and Drug Administration. 30 Jun. 2017. Web.
- Whyte, Joe. “Seven Steps for Serialization-Ready Machines.” Industry Week. 8 Jul. 2014. Web.