Mandates that pharmaceutical products be serialized, tracked, and traced are being implemented throughout the world. In preparation, the pharmaceutical industry is revamping packaging lines and distributors are developing strategies to track every unit, from the pallet down to the vial, as it moves from the manufacturer all the way to the patient.
Implementation already is starting in Latin America countries. U.S. mandates take effect in 2015 for manufacturers, 2016 for distributors and 2017 for pharmacies. China’s requirements take effect June 1, 2013 with a three year phase-in. India’s requirements also take effect this year, and EU regulations take effect in 2014.
Serialization is a watershed event that dramatically expands the data being monitored. A Veteran’s Administration pilot project even added track-and-trace information to patients’ charts, allowing complete traceability all the way to the specific processing line.
When data from temperature monitors is added to that information, pharmaceutical manufacturers, suppliers and healthcare providers will be able to access a drug’s complete handling history, enabling tightly targeted recalls and improving pharmaceutical safety.
Temperature monitors’ unique serial numbers add to the security. They can’t be replaced surreptitiously during shipments, thus assuring recipients that the monitoring data is trustworthy. The presence of serialized temperature monitors also makes it more difficult for counterfeiters to divert product because, if serial numbers change or temperature excursions occur, receivers know something is amiss and will examine the contents closely.
To learn more about how ShockWatch can help secure your supply chain, contact us.