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Serialisation of small batches

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Driving pharmaceutical innovation

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 US Drug Supply Chain Security Act (DSCSA) and the EU Directive on Falsified Medicines, has been created to enforce this. Under the DSCSA, for example, companies will have to introduce serialisation 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 serialisation 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 and uphold brand integrity, plus it can also standardise their global operations to maximise efficiency, reduce bottom-line costs and protect profit margins.

About Mettler-Toledo Product Inspection

Mettler-Toledo PCE is a leading supplier of track & trace solutions. Together with Mettler-Toledo Safeline, Highspeed Checkweighing and CI-Vision, PCE forms the Product Inspection division of Mettler-Toledo.

Mettler-Toledo develops, produces and markets precision instruments worldwide. The company is one of the largest suppliers of weighing and quality control systems in the world, whose products are used in laboratories as well as industrial processing and food retailing applications. Renowned producers of all conceivable everyday products rely on Mettler-Toledo’s technology as an important aid to delivering consistent product quality and innovative developments. These producers reap the benefits of the company’s global presence, and sales and service network.

Mettler-Toledo’s corporate philosophy centres around high-quality standard and tailored solutions. The company forms a true partnership with its customers, providing support during the selection of appropriate systems and working together to develop unique solutions that increase process efficiency, reduce overall manufacturing costs and improve competitiveness.

For general information on Mettler-Toledo Product Inspection, visit: http://www.mt.com/pi.

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Serialisation of small batches