Recipharm, a leading contract development and manufacturing organisation (CDMO) has equipped its sixth facility with serialisation capabilities ahead of the US and European regulation enforcement deadlines.
The facility in Lisbon is the latest of Recipharm’s facilities to be prepared to start supplying serialised products to the US and Europe, following a EUR 40 million investment into its company-wide implementation programme in 2016.
Recipharm has already delivered over 1.3 million serialised and aggregated packs to markets such as, China, South Korea, Saudi Arabia and Turkey where serialisation regulations are currently in place. The Lisbon site is the sixth to become serialisation-ready for the US and European markets and adds an additional four packaging lines to the company’s current serialisation capabilities. This will be followed by a further seven lines at the facility by Q2 in 2018.
Staffan Widengren, Director of Corporate Projects at Recipharm and head of the global steering committee for Recipharm’s serialisation project said: “Recipharm recognised the complexity of implementing serialisation at a very early stage and so we’ve been preparing for the new regulations in the US and Europe for a long time now. The Lisbon facility brings us to over a third of the way through our implementation project and is an important milestone in our journey.”
“We introduced our serialisation programme to ensure a consistent roll-out of our standard solution, without the implementation process having a significant impact on production activities. It’s important our solution works at a local level, as well as company-wide, and the central team that heads up the programme is tasked with making this happen.”
“Effective serialisation capabilities can eventually help companies to improve their overall equipment effectiveness (OEE) and streamline their operations. The programme also helps us to ensure that serialisation data integrates with our enterprise resource planning (ERP) activity and our manufacturing execution systems (MES) so that we can achieve wider business benefits beyond compliance.”
The central team is responsible for identifying, ordering, installing and qualifying serialisation systems in line with customer requirements. The next site to be equipped will be the company’s facility in Brescia, which will supply serialised product to the US.
Recipharm’s serialisation programme was recently recognised in the TRACKTS Awards 2017 as an example of best practice for its execution of a track and trace system at the Lisbon facility following a detailed assessment of the project’s methodology, use of technology and innovation.
Director Corporate Projects,
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Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing around 5,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 5.3 billion and the company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden.
Serialisation is a means to trace and track pharmaceuticals from manufacture through to prescription, using bar codes to record information about product origin, shelf life and batch. This will help the fight against counterfeit products entering the supply chain and ultimately improve patient safety.