Rexam Healthcare extends its quality certification panel by obtaining standard ISO 15378 for a third European site

Rexam's Le Treport site, already certified according to ISO 9001 (Management of the quality system) and ISO 13485 (for medical devices) is now certified according to ISO 15378.

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It is the third European site of the Healthcare division to obtain this standard, the guarantee of an ongoing quality strategy.

Rexam's Le Tréport site is specialised in state-of-the-art drug delivery systems. It is now one of the biggest industrial sites in France for injection moulding machines (more than 100). It has just celebrated its fiftieth anniversary and recently received the support of the European Union for the development of a new pump reference for nasal sprays.

WorldPressOnline First Call - After the certification of two of its European sites, Rexam Healthcare, which is engaged in a global approach resolutely committed to 'patient safety', was awarded ISO 15378:2006 certification for a third production site based at Le Tréport in France.

The ISO 15378 standard is specifically developed for manufacturers of primary packaging for pharmaceutical products. It attests to an integrated quality management system which for the first time combines standard ISO 9001:2000 and compliance with good manufacturing practices (GMP) in order to meet the strictest requirements of the pharmaceutical industry.

'It is an important step for Rexam Le Tréport, complementing the list of Healthcare sites which have already obtained a similar level of certification. It represents confirmation of this site's rigorous implementation of GMPs. It ratifies Rexam Healthcare's commitment to patients and rewards the teams' dedication to quality', says Marc Haemel, Managing Director of Rexam Healthcare.

This certification process is ongoing for all the sites. Whatever the geographic location, the most demanding international regulatory and legal standards are carried out at every stage of the process, from design to manufacturing and delivery.
'Our teams throughout the world are trained in the same way in complying with regulatory standards, processes and controlling risk management', adds Christian Meusinger, Global Quality Director Rexam Healthcare.
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