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Pharmaceutical manufacturers will be-and are already&mdashfacing enormous challenges to implement the serialization regulations within the given timeframe.
Packaging machinery suppliers describe how changes in regulations have driven developments in packaging and look ahead to coming challenges.
Serialisation is among the major trends and future challenges for the pharmaceutical industry. Growing internet sales, outsourcing of production and more complex supply chains require at least national, if not international, legislation to secure pharmaceutical products and, most importantly, to protect patients from counterfeited medicines. Currently, new guidance and legislation are being developed and implemented by numerous countries, such as Argentina, China and Brazil, whose health surveillance agency, ANVISA, adopted a new resolution at the end of 2013.
The United States Food and Drug Administration (FDA) requires pharmaceutical producers to apply a standard numerical identification (SNI) to the packaging of all prescription drugs in a step-by-step approach beginning in 2017. The European Union’s Falsified Medicines Directive (2011/62/EU) also stipulates uniquely coded, serialised packs for almost all prescription drugs. Moreover, the EU has defined a second layer of security to be provided by tamper-proof closures that indicate whether a package has been previously opened or tampered with.
Pharmaceutical Technology Europe25th Anniversary Issue
Pharmaceutical manufacturers will be—and are already—facing enormous challenges to implement the respective regulations within the given timeframe. And this implementation is not going to be an easy task. Most companies must develop and apply a global strategy for the consistent serial-number assignment, management and storage on all levels—from devices, line processes and line management to production and enterprise control. Such solutions must be compatible with in-house processes, such as manufacturing execution systems, which in turn require the adaptation of highly demanding packaging processes.
These solutions must be compatible with existing line concepts, and they must be extendable to all possible aggregation levels, including bundling, shipping cartons and pallets. The safest approach undoubtedly consists in a multilayer machine and software concept, which should take all requirements into account and combine all necessary processes in one modular, yet complete system that complies with the industry’s demand for consistent and high-quality operations and with patients’ demands for higher safety.
About the Author
Johannes Rauschnabel, PhD, is chief pharma expert at Bosch Packaging Technology.