trans-o-flex: Recertification according to ISO standards and GDP guidelines

The logistics group trans-o-flex has successfully completed the reviews according to DIN EN ISO 9001:2015 (Quality Management System) as well as the Good Distribution Practice (GDP 2013/C343/01) for pharmaceuticals. For this purpose, the certification company BSI Group Germany examined all German trans-o-flex companies for almost a month.

(Weinheim) On the one hand, compliance with the current quality standard DIN EN ISO 9001:2015 was certified. On the other hand, the auditors confirmed trans-o-flex’s adherence to the demanding Good Distribution Practice (GDP), which is important for the pharmaceutical and healthcare sectors. Trans-o-flex first had its quality management system certified in 1995. The GDP compliance was first certified in 2010 and then elevated to a new level in 2013 with the publication of the new EU GDP. “Compliance with GDP guidelines has been a matter of course for us as a specialist in the pharmaceutical and healthcare market for years,” says Wolfgang P. Albeck, CEO of trans-o-flex. “Our pharmaceutical customers can thus demonstrate during regulatory inspections that the safety and quality of the medicines were ensured at all times during storage and transport. The GDP certification reflects the quality of trans-o-flex, which naturally also benefits customers outside the healthcare sector.”

As part of the external audit by BSI, the quality management systems and GDP compliance of trans-o-flex Express, the trans-o-flex network companies, trans-o-flex Logistics Service, and trans-o-flex ThermoMed (specialist for actively temperature-controlled transport at 2 to 8 degrees Celsius) were examined. This simultaneously reviewed the processes of all German trans-o-flex companies in the areas of storage and transport. In addition, the temperature ranges particularly relevant for pharmaceuticals were investigated: active temperature control at 15 to 25 degrees Celsius and at 2 to 8 degrees Celsius. The certificate confirms that trans-o-flex meets the European guidelines for the storage and transport of non-refrigerated health products as well as the requirements for temperature-sensitive medicines. The criteria examined include quality control, training, safety, cleanliness, and internal monitoring procedures. The new certification of trans-o-flex is valid for three years. After that, a complete recertification is due.

Photo: © trans-o-flex