Keeping track of items is one of the highest priorities for not only manufacturers, but essentially every organization involved in the supply chain. Traceability is a focus for multiple industries, including agriculture and pharmaceuticals, and there are numerous government regulations that aim to ensure companies are complying with these rules. However, some sectors are calling for even more action on the part of regulators. According to a recent article posted on the PharmExec.com blog, those involved with manufacturing and distributing prescription medication will be required to collect and transmit information pertaining to its movement under the Drug Supply Chain Security Act. In fact, Jan. 1, 2015 is the deadline established by the U.S. Food and Drug Administration to have a data collection system in place that will allow plant operators, packagers and all enterprises involved in distribution to provide the government agency with accurate records.
Making Medications More Secure
As the primary part of the Drug Quality and Security Act, the DSCSA targets the U.S. drug supply chain, hoping to prevent pharmaceuticals from getting lost as they're transported between various locations and protect consumers from falling victim to counterfeiting. Janet Woodcock, director of the Center for Drug Evaluation and Research, explained an electronic tracking system would help the pharmaceutical industry prevent shortages and limit the damage done by product recalls.
Food Industry Sets the Precedent
This move is comparable to the steps taken by the FDA to help protect the food supply chain. According to the RFgen white paper "The Food Traceability Survival Guide," the government established the 2001 Bioterrorism Act and the 2011 Food Modernization and Safety Act. The former requires all food processors to record the origin of all food items, as well as their ingredients. If a business isn't able to provide the FDA with concrete proof of this information within 24 hours of the request, they may face civil and criminal actions. With regard to the FMSA, the FDA began creating a food product tracing systems and reinforced the regulatory body's ability to order recalls.
Data Automation at the Core of Traceability
According to the white paper, automated data collection software solutions combined with a robust ERP system can help give manufacturers and distributors better visibility into their supply chains. Additionally, recalls can be handled with greater dexterity, and it's far easier for these organizations to comply with government regulations. For instance, automated data collection software helps businesses excel at keeping track of batch and serial numbers, which are critical to retain in the event of a recall.
The pharmaceutical industry will likely be put in a similar situation as the DSCSA takes full effect next year. According to PharmExec.com, the FDA is still consulting with stakeholders involved with the prescription drug supply chain to get a better understanding of any unique challenges manufacturers and distributors may face. Currently, the focus will be on three items, which are transaction information, history and statements. These records must be kept for six years, either in paper or electronic formats. However, given the fact that all parties will have to submit requested information to the FDA quickly, it makes more sense to invest in an electronic, automated system.