Quality management at the PEI
The Paul-Ehrlich-Institut maintains a quality assurance system for the marketing authorisation and batch control testing of immunobiological products, which is part of the European network of regulatory authorities. This quality assurance system meets the requirements of the German standard DIN EN ISO/IEC 17025 (ISO 17025). Setting up a quality management system has a direct connection with the claim that test methods and their results are comparable, both between Official Testing Laboratories in Europe on the one hand and between regulatory authorities and pharmaceutical companies on the other.
The ISO 17025 standard contains all requirements for the competent use of test methods that lead to valid results of tests on medicines. At the same time, it also covers the requirements of the ISO 9000 series which concern the way in which an organisation is managed.
The setting up of the quality management system at the Paul-Ehrlich-Institut also guarantees a basis of quality assurance for standardised processes, including processes of marketing authorisations at the institute.
The lab areas of the Paul-Ehrlich-Institut were inspected by DACH (Deutsche Akkreditierungsstelle Chemie GmbH, the German accreditation body for the chemical industry) and are now monitored regularly. Up to now, two thirds of all methods used in the testing of biologicals and veterinary medicines have been accredited.
Pursuant to Article 4 (1) of Regulation (EC) No. 765/2008, each Member State must now appoint a single national accreditation body. To meet this requirement, Germany had to establish the appropriate body which fulfils Regulation (EC) No. 765/2008 by 1 January 2010. With the coming into force of the German law "AkkStelleG" (Gesetz über die Akkreditierungsstelle, Act on the Accreditation Body) on 7 August 2009, the legal framework for establishing the national accreditation body in Germany was created. The latter accreditation body now has the function of performing all accreditations pursuant to EU Regulation No. 765/2008.
The DAkkS (Deutsche Akkreditierungsstelle) acting as a contract accreditation body (in behalf of the BMWi) has been established since late 2009 and now fulfills the requirements pursuant to Section 8 of EU Regulation 765/2008, ISO/IEC 17011, and AkkStelleG.
The BMWi (Bundesministerium für Wirtschaft und Energie), Federal Ministry for Economic Affairs and Energy) bears the overall responsibility for establishing this national accreditation body in Germany, and started transposing this regulation into German law immediately after AkkStelleG came into force in August 2009.
Based on the change in the laws and the situation of change in the national accreditation bodies, the Paul-Ehrlich-Institut has applied for a supervision of the system and an extension of the accreditation at the private law based predecessor organisations and the DAkks (Deutsche Akkreditierungsstelle, German Accreditation Body). The first assessment took place in January 2010. Ever since then, several accreditations have been performed.
With effect of 13 September 2016, the DAkkS has again granted an accreditation pursuant to ISO17025 to the Paul-Ehrlich-Institut.
The exact types of tests and test methods are listed in the annex of the accreditation certificate and accreditation notice D-PL-13085-02-00, of which an online version is available on the PEI website. Our aim is to achieve a constant extension of the accreditation for our test methods by the DAkkS.
With regard to marketing authorisation related processes, the Paul-Ehrlich-Institut is taking part in benchmarking. This is established within the EU network of regulatory authorities. The aim of benchmarking is to contribute to a development which leads to an internationally competitive regulatory network of authorities which practice the best standards in the field of regulatory affairs.