Highest Quality in Product Testing

Experimental product testing is a core task of the Paul-Ehrlich-Institut. It serves as an important instrument to ensure the quality, safety, and availability of vaccines and biomedicines in Germany and Europe. The batches of vaccines and biomedicines are tested before they are available on the market. The rules for product testing in Europe are laid down by a network of Official Medicine Control Laboratories (OMCLs). The Paul-Ehrlich-Institut is an OMCL for a number of medicines.

Both the testing laboratories and the test methods used for product testing are audited and accredited on a regular basis, because they must fulfil high quality standards. The previous accreditation of the Paul-Ehrlich-Institut fulfilled the requirements of the 2005 version of the standard DIN EN ISO 17025, which loses its validity in late 2020. For this reason, like other testing laboratories, the Paul-Ehrlich-Institut was required to change over to the 2018 standard in order to maintain its status as accredited laboratory. The valid accreditation ensures that the Paul-Ehrlich-Institut maintains and extends its strong position in the European OMCL network of the European Directorate for the Quality of Medicines, EDQM.

Two years of extensive preliminary work for upgrading to the new standard

In early 2018, the German version of the standard was available with a stronger focus on personnel monitoring and the IT processes as well as risk management. Based on a detailed change-over plan (gap analysis), the Paul-Ehrlich-Institut succeeded in revising the standard operating procedures (SOPs) of the QM in their entirety, and in performing the required adaptations in the testing laboratories of the Paul-Ehrlich-Institut by May 2020. The DAkkS audited the optimised working processes and confirmed the successful audit by issuing the appropriate accreditation certificate.