Innovative technology will ensure manufacturers conform with impending legislation

Reinhold van Ackeren, Mettler-Toledo Pharmacontrol Electronic (PCE), discusses driving innovation in the pharmaceutical sector.

Whether talking about the development of supply chain traceability or the implementation of stringent regulations, the pharmaceutical industry has long been at the leading edge.

Companies are increasingly seeking innovative ways to standardise both their own production processes internationally and those of their contract manufacturers to uphold quality while at the same time optimising line efficiency. Advanced data monitoring technologies are increasingly being used to achieve this in combination with enterprise resource planning (ERP) software. These technologies are helping to boost transparency in the value and supply chain, ensuring consistent product quality and limiting unofficial “grey market” activities, while also cutting operating costs to keep up with competitors.

At the same time, there has been growing concern among lawmakers and manufacturers alike about product counterfeiting and its effect on consumer safety and brand reputation. This has led to calls for improved product traceability throughout the pharmaceutical supply chain to prevent false or counterfeit medicines reaching end consumers and to minimise the risk of product recalls or mix-ups.

New legislation, such as the European Union (EU) Falsified Medicines Directive or the US’ newly introduced Drug Supply Chain Security Act (DSCSA), has been created to enforce this. Under the DSCSA, for example, companies will have to introduce serialization at package level by 2017, as well as ensure comprehensive reporting of the history of the batch both from their own lines and those of their contract manufacturers.

There are innovative technology solutions available now to help pharmaceutical manufacturers to meet these trends. Manufacturers can make use of cutting-edge serialization systems, that not only provide comprehensive product traceability, but also offer advanced network connectivity to enable both track-and-trace data and production status information from all global operations to be stored in a single location. Such technology will help manufacturers comply with the strictest regulatory requirements, uphold brand integrity, plus it can also standardise their global operations to maximise efficiency, reduce bottom-line costs and protect profit margins.