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insights LIFESCIENCELEADER.COM MARCH 2014 68 PHARMA MANUFACTURING SERIALIZATION — PHARMA FACES 2015 DEADLINE By G. Dutton G R E G C A T H C A R T CEO of Excellis Health LLC than determining what data to extract and what report format to use." INCORPORATE A GLOBAL APPROACH Traceability is a global need, and "The U.S. serialization law lags behind those of other countries," says Michael Lucas, president and founder at Frequentz, a track-and-trace technology specialist. Given the global proliferation of serial- ization regulations, "This law has mar- ginal to no impact on the overall global traceability requirements and planning efforts. Serialization laws and regula- tions have already been piloted, if not fully executed abroad." Serialization requirements are in vari- ous stages of development in the EU and in its member nations, as well as in Turkey, India, China, Brazil, Argentina, and Korea. The most recent change occurred in Brazil, which in December published RDC 54/2013, specifying track- and-trace requirements. According to that document, manufacturers must provide serialization and tracking data for three batches of products by Dec. 10, 2015. All pharmaceuticals must be serialized and tracked by Dec. 10, 2016. "For a growing market, that's a critical milestone," Young says. The first public hearing discussing implementation was held Jan. 23, 2014. With so many different reporting requirements throughout the world, one- size-fits-all responses are inadequate. "You have to take a harmonized approach to compliance," Young says. "Think from a global perspective, and then break the program down for specific countries." As implementation deadlines approach, "There's no more breathing room," Mooraj adds. "Manufacturers need to get this right." L the FDA must provide additional guid- ance regarding identification and dispo- sition of suspect and illegitimate product by May 2014. That leaves manufacturers only a few months to implement compli- ance strategies, she points out. Another challenge, according to Young, is that the FDA now has oversight of processes and operations in which it may not have deep experience. "Therefore, companies may be forced to spend extra resources to make their processes more straightforward and consistent (both in-house and with the industry). For example, in the logistics and supply chain space, many organizations — especially the smaller ones — haven't thoroughly documented their processes. So, when FDA regulators ask for details of a partic- ular process, like they do for manufactur- ing, many companies may not be ready to reply. Therefore, life sciences companies must become more vigilant [about docu- menting their supply chain processes]." USE SERIALIZATION TO INCREASE VISIBILITY Mooraj encourages companies to look beyond the deadline and focus upon the opportunities serialization offers. "The companies that will succeed are those with concurrent strategies to meet the requirements and to extract value by increasing visibility into the global sup- ply chain," he says. "Don't lose sight of longer-term efforts. Think about ways to extract value from these investments." The data required for serialization should be in demand throughout the sup- ply chain. The level of tracking enabled by serialization enables forward-thinking companies to use that data to gain more comprehensive understanding of the entire supply chain and, for example, min- imize distribution bottlenecks and more tightly target recalls. Additional uses may be identified once the FDA guidelines are developed. The immediate challenge, Kovary says, is determining how best to collect and move this data while meeting the yet-to-be- established FDA requirements. "While we can't predict the exact FDA requirements, in today's sophisticated electronic world, this hopefully would be nothing more "To meet lot-level pedigree compliance, companies have 13 data elements that must be incorporated," Cathcart points out. "These elements include the name of the authorized reseller, product quantity, lot number, and container size. The infor- mation must be stored and made avail- able to the FDA within 24 hours." That means a database of authorized trading partners must be developed, he adds. "Additionally," Cathcart says, "wholesal- ers must be able to receive the data, make it available for FDA audits, and send it with their sales information downstream to their customers. However, the FDA guidance interpreting these requirements isn't due until Nov. 27, 2014," one month before mandatory implementation. "A wait-and-see approach will not leave us much time to implement a proper solution," Kovary says. Daiichi is assess- ing the requirement and identifying options now. Hussain Mooraj, global managing director, life sciences supply chain and ERP (enterprise resource planning) for Accenture, cautions, "We expect this lot- based regulation to potentially disrupt the industry by forcing manufacturers to divide their resources between this requirement and maintaining momen- tum for unit-level serialization." THIRD-PARTY ISSUES INVOLVED The federal mandate also includes a pro- vision to deal with suspicious and ille- gitimate products. It calls for quarantine, an investigation with trading partners, FDA notification with 24 hours, and, by November 2017, the ability to verify the product at the package level with a stan- dardized numerical identifier. For some, that's a backburner issue that will be addressed in concert with their third- party distributors. Pfizer is engaging with the FDA and industry to better understand the requirements regarding suspect and ille- gitimate product. "To some degree, we have a system in place," Staver says. "For example, today if a pharmacy sees a sus- pect product, it phones us to check the lot number, discuss any recent packaging changes, and determine appropriate next steps." To implement the new approach, To meet lot-level pedigree compliance, companies have 13 data elements that must be incorporated. 0 3 1 4 _ P h a r m a _ M a n u f a c t u r i n g 3 . i n d d 2 0314_Pharma_Manufacturing3.indd 2 2 / 1 9 / 2 0 1 4 2 : 4 6 : 4 2 P M 2/19/2014 2:46:42 PM