Packaging

REXAM PHARMA ACHIEVES ISO 15378 CERTIFICATION

Rexam Pharma is successfully certified in accordance with ISO 15378 :2006 for two of its production sites located in Neuenburg, Germany and La Verpillière, France.

Monday 29. June 2009 - Rexam Pharma is successfully certified in accordance with ISO 15378 :2006 for two of its production sites located in Neuenburg, Germany and La Verpillière, France.

This new ISO 15378 norm was published in August 2006 and aims at the pharmaceutical primary packaging manufacturers. ISO 15378 is a complete quality system which combines ISO 9001 and the requirements of the Good Manufacturing Practices (GMP) for the first time.

“We are proud to achieve this certification which guarantees to our customers that we meet the most stringent regulated market requirements. This is a further step we crossed successfully” says Marc Haemel, Rexam Pharma Managing Director.

Rexam Pharma is engaged in a global initiative focused on patient safety. “On each location all around the globe, our team are trained the same way in the respect of regulatory standards, clean room imperative, traceability, validation, change control and respect for processes and in risk-management.” Adds Christian Meusinger, Global Quality Director Rexam Pharma.
Whatever the geographical presence of the industrial site, each step of the entire process, from design to manufacturing and delivery will obey to the most demanding international statutory and legal standards.
The certification ISO 15378 rewards the investment of the teams and allows Rexam Pharma to position as a quality guiding with its customers.