The Paul-Ehrlich-Institut (PEI) is part of the European Network of Official Medicines Control Laboratories (OMCL). For two decades, the Paul-Ehrlich-Institut test laboratories have been working with a quality management system (QM system) that meets the requirements of DIN EN ISO / IEC 17025 (ISO 17025). In the field of authorisation and testing, the quality assurance of standardised processes are established for authorisation and testing of medicinal products. The quality policy of the Paul-Ehrlich-Institut aims at promoting the quality, tolerability and efficacy of vaccines and biomedical medicines. The aim of the QM system is to ensure that the Paul-Ehrlich-Institut can demonstrate the required competence at all times and in all areas of responsibility that contribute to the quality of the marketing authorisation and product testing. This competence is a prerequisite for the worldwide recognition of the test methods and results used in the Paul-Ehrlich-Institut.
In connection with the standard "General Requirements for the Competence of Testing and Calibration Laboratories" (ISO 17025), the Paul-Ehrlich-Institut complies with the requirements of the German Accreditation Body (Deutsche Akkreditierungsstelle, DAkkS) and the European Directorate for the Quality of Medicines & HealthCare (EDQM). Quality aspects are implemented in accordance with the DIN EN ISO 9000ff series. The requirements of DIN EN ISO 19011 are incorporated into the internal audit system of the Paul-Ehrlich-Institut.
The regular monitoring and accreditation of the laboratories of the Paul-Ehrlich-Institut by the DAkkS and the auditing by the EDQM ensure that the relevant standards are applied correctly and effectively. The Paul-Ehrlich-Institut has been accredited for a variety of test methods for years.
Together with other European pharmaceutical regulators, the Paul-Ehrlich-Institut is committed to health for humans and animals (One Health) within Europe. It also participates in the field of quality assurance in the benchmarking of the European Medicines Agency (BEMA), which was established within the EU Network of Authorities (HMA). In this independent evaluation of its authorisation, testing and management processes, the Paul-Ehrlich-Institut achieves excellent results in its role as a drug agency.
The Paul-Ehrlich-Institut publishes all relevant aspects of its QM system in the QM manual.
Updated: 29.04.2025
