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Abstract
As per the new Drug Quality and Security Act, pharmaceutical packaging companies are now required to implement serialization systems in their packaging lines in order to provide complete traceability of all packaged medication. Furthermore, this measure tends to combat the trade in counterfeiting medicines and also seeks the extinction of cargo thefts. The paper details the feasibility study of such a system for a local pharmaceutical company and the study of its impact on critical performance parameters such as efficiency, lead time etc. The study represents a practical application of Lean tools such as value stream mapping, failure mode effect analysis and simulation in the analytic thinking process. The new system is shown to reduce the rejection rates of the bulk thereby improving the efficiency of the system. After the requirements of the line were learnt through the study, three vendors were researched for the implementation of serialization system.
Keywords
Serialization, traceability, anti-counterfeiting, simulation
1. Introduction
The Pharmaceutical industry is one of the most profitable industries in the world, having companies with margins up to 42% in 2013 [1]. According to the World Health Organization (WHO) [2], the market of pharmaceuticals globally is worth three hundred billion dollars a year, with expectations to keep rising in the following years. This level profitability makes this business very seductive for organized crime [3].
The Pharmaceutical Security Institute (PSI) is dedicated to "protect public health by sharing information on pharmaceutical crime and initiating enforcement actions through appropriate authorities" [4]. They have defined three areas for pharmaceutical crime: counterfeit medicine, illegal diversion and pharmaceutical theft. An additional issue that depends on the geopolitical circumstance would be considered a crime is "substandard medicines" [5]. Counterfeit medicine is defined by PSI as "products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product" [4]. WHO expands the definition to include a broader set of possible cases and names the violation as a "spurious/falsely labeled/falsified/counterfeit (SFFC) medicine" [6]. According to PSI, "illegal diversion occurs when a genuine pharmaceutical product is approved and intended for sale in one country, but is then illegally intercepted and sold in another country" and pharmaceutical theft is an "illegal taking of medicines in the...