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Quality Policy of the Paul-Ehrlich-Institut

The Guiding Principles of the Paul-Ehrlich-Institut (PEI) are laid down in writing. They are communicated both in-house and externally. These principles have been supplemented in 2013 by the Guidelines on leadership and cooperation. Since 2005, as part of the Guiding Principles, the PEI has also formulated Strategic Objectives in internal and external fields of action as well as Vision, Mission and Strategy of the institute.

The quality policy of the PEI primarily serves to fulfil the institute’s mission, in other words the further development of quality, safety, and efficacy of vaccines and biomedicines. In this context, the PEI is entitled to set international targets in these areas, which shall also be achieved through a consistent interaction between marketing authorisation and research.

  • The quality management of the PEI shall be conducted in conformity with EN ISO/IEC 17025, taking into account the standards EN ISO9000 ff. in a manner appropriate for guaranteeing Good Professional Practice and quality. The test procedures performed and the areas where tests are performed are publicly accessible and are listed in the Annex to the Accreditation Certificate (Only available in German) (pdf, 3.8 MB, File does not meet accessibility standards.).
  • Quality is a primary objective at the PEI. Commercial, financial, or other factors must not affect the quality of the work. This requirement is not in contradiction with the principles of cost-effectiveness and efficiency to which the PEI is obliged to adhere. Resources needed to perform quality management and the workload and costs involved must be in keeping with the quality objectives.
  • The aspect of continued improvement is a basic concept. It must be fulfilled at all times by the quality management of the PEI. This includes both the exchange of constructive criticism and open and subject oriented handling of errors.
  • In future, management by objectives and quality management shall be more strongly interwoven at the PEI than was the case previously. The institute has already established a method of deducing objectives from quality requirements and the annual observation and evaluation of these objectives by the management of the institute. A closer link between quality, professional, and management objectives can provide additional positive synergies in this context.
  • Quality management can only be conducted in an efficient and effective manner if conveyed adequately and to those concerned. For this reason, it is imperative to conduct continued training in quality documentation and constant tuition to further professional skills and social competence.
  • The opportunities given to the PEI by the flexible accreditation from DAkkS (Deutsche Akkreditierungsstelle, German Accreditation Body) shall be used in a responsible manner. This means that newly validated methods in flexibly accredited areas shall not be considered as accredited before a successful internal audit has been conducted on the new method involved and no further deviations have been established, i.e. any possible deviations have been eliminated.
  • Collaborative trials are performed for methods in the area of accreditation to guarantee continued quality. For this purpose, a 5-year plan is prepared. For areas where no collaborative trials are put in place, strategies are developed within the management assessment (which is regularly prepared) to maintain the professional competence in the accredited areas.
  • International policies are used to determine the content and procedure of testing activities of the PEI. At the same time, the PEI takes an active part in the further development of these international policies. This directly relates to the claim of comparability between harmonized test methods of European Official Test Laboratories and regulatory authorities with pharmaceutical manufacturers.

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