Falsification-proof and reliable processes with Track & Trace Pharma

摘要

IN THE pharmaceutical industry, this topic is still generating a great deal of attention: the European Falsified Medicines Directive (2011/62/ EU), which entered into force on 9 February 2019, requires all prescription medicines to be clearly labeled in a way that allows the entire production and transport process to be traced. These serial numbers are registered with a central European database and verified by pharmacies, before they hand over the medicine, by scanning a data matrix code. This procedure aims to protect consumers against falsified medicinal products. For pharmaceutical manufacturers, this directive implies major overhauls in production, since new structures and systems need to be established to perform this labeling. What is needed in this context are Track & Trace systems such as the TQS (Traceable Quality System) from WIPOTEC-OCS. Another useful component that provides additional process security for Track & Trace systems during format changes is the position indicator AP05 from SIKO GmbH, a specialist for industrial measuring and drive technology.