- Recertification according to DIN EN ISO 9001:2015 received once again
- Conformity with the guidelines on Good Distribution Practice (GDP) for medicinal products for human use (2013/C343/01) certified.
Weinheim, 29 August 2022. The logistics group trans-o-flex has once again successfully passed the audits 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 Deutschland audited all German trans-o-flex companies for almost a month. 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 compliance with the demanding Good Distribution Practice (GDP), which is important for the pharmaceutical and healthcare industry. trans-o-flex first had its quality management system certified in 1995. GDP conformity was first certified in 2010 and then raised to a new level in 2013 with the publication of the new EU-GDP. “As a specialist in the pharmaceutical and healthcare market, compliance with the GDP guidelines has been a matter of course for us for years,” says Wolfgang P. Albeck, CEO of trans-o-flex. “Our pharmaceutical customers can thus prove during official inspections that the product safety and quality of the pharmaceuticals were also guaranteed at all times during storage and transport. The GDP certification reflects the quality of trans-o-flex, which of course also benefits customers outside the healthcare industry.”
As part of BSI’s external audit, the quality management systems and the GDP conformity of trans-o-flex Express, the trans-o-flex network companies, trans-o-flex Logistik-Service and trans-o-flex ThermoMed (specialist for actively temperature-controlled shipments at 2 to 8 degrees Celsius) were audited. This involved auditing the processes of all German trans-o-flex companies in the areas of warehousing and transport at the same time. In addition, the temperature ranges particularly relevant for pharmaceuticals were checked: 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 health products that do not require refrigeration as well as the requirements for temperature-sensitive pharmaceuticals. The criteria audited include quality control, training, safety, cleanliness and internal monitoring procedures. The new certification of trans-o-flex is valid for three years. After which full recertification is due.