Quality assurance

GXP – quality assurance according to international standards

Fraunhofer ITEM is striving to meet high quality standards with the services and products offered and to ensure maximum safety for trial subjects in clinical studies performed at the institute. Not only are the relevant legal regulations strictly complied with, but state of the art regulatory requirements are invariably taken into consideration.

To guarantee that the work performed at Fraunhofer ITEM satisfies internationally accepted quality standards, Fraunhofer ITEM has implemented the GXP quality assurance systems. These include Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). With their respective scopes of application, these quality assurance systems cover the translational approach in the institute’s spectrum of activities. The central service unit “Quality Assurance” is responsible for putting into practice the relevant quality assurance programs.

 

GLP conformity of non-clinical safety studies

 

To ensure reliability and traceability of the data generated in non-clinical health and environmental safety studies, the GLP principles include, among others, the following requirements:

  • Clear assignment of responsibilities within the test facility
  • Meticulous planning and qualified performance of every study
  • Complete documentation of all procedures and preparation of comprehensive reports

By means of study-based and facility-based inspections, the service unit “Quality Assurance” continuously monitors compliance with these principles in the institute’s departments of toxicology, safety pharmacology, and analytics. During the past two decades, the competent authorities have performed regular inspections and certified the institute’s GLP conformity for a broad range of studies. On the occasion of a reinspection in September 2018, the authorities furthermore confirmed GLP conformity of the test facility including the Department of Biomarker Analysis and Development. The established quality assurance system thus guarantees to all sponsors an internationally recognized quality standard in the institute’s departments performing non-clinical studies.

Fraunhofer ITEM GMP facilities

 

All manufacturing and quality control steps for investigational medicinal products to be used in clinical trials – including challenge agents – are subject to stringent GMP requirements.

© Fraunhofer ITEM
Fraunhofer ITEM Hannover
© Fraunhofer ITEM, Ralf Mohr
Fraunhofer ITEM Braunschweig

GMP facilities at the institute’s Hannover site

To enable patient-specific dilution and aseptic fill and finish of investigational medicinal products (liquid dosage forms) in spatial proximity to the clinical departments, an appropriate GMP facility was successfully established at Fraunhofer ITEM in Hannover a few years ago. Furthermore, the possibility to manufacture ozone according to GMP for use as a challenge substance in clinical inhalation trials has been established and confirmed by the competent authorities. A corresponding GMP manufacturing authorization was granted by the competent authorities, but is dormant for the time being. The service unit “Quality Assurance” ensures that the regulatory conditions for resuming manufacturing operations, whenever needed, are met.

 

GMP facilities at the institute’s Braunschweig site

The Division of Pharmaceutical Biotechnology in Braunschweig has comprehensive expertise and a long track record in the development of GMP manufacturing processes for biopharmaceuticals. For this purpose, the division has established a GMP quality assurance system to ensure compliance with the German Drug Act, the German Ordinance on the Manufacturing of Medicinal Products and Active Ingredients (AMWHV), and the European Union GMP Guidelines. Other guidelines are also taken into account, e.g. those of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).

The division operates clean rooms of grades D to B according to Annex 1 of the EU GMP Guide, subdivided into different zones satisfying the respective hygiene and pressure requirements. Steam and water quality meets the requirements of the European Pharmacopoeia. All critical equipment for the manufacture of medicinal products has been qualified in compliance with Annex 15 of the EU GMP Guidelines. An automated filling machine enclosed in a restricted-access barrier system (RABS) of clean-room grade A in a clean-room grade B environment is available for manufacturing of small batches of sterile investigational medicinal products (IMPs) for use, for example, in clinical trials or stability testing.

The division has been repeatedly inspected by local and national authorities – the most recent inspection was successfully completed in March 2018 – and holds a manufacturing and importation license for microbial or animal cell culture biopharmaceutical APIs and for IMPs.

Biopharmaceutical products can thus be developed in collaboration with industrial and academic partners and can consistently be manufactured to the required quality – from initial cell line development and manufacturing of master cell banks to the optimization of production steps and the released IMP

 

GMP manufacturing authorization Fraunhofer ITEM, Braunschweig site

GMP certificate Fraunhofer ITEM, Braunschweig site

 

Contact

Jens Gerdelmann

Contact Press / Media

Dr. Jens Gerdelmann

Head of Quality Assurance at the Hannover site

Phone +49 511 5350-349

Neophytos Papamichael

Contact Press / Media

Dr. Neophytos Papamichael

Head of Quality Assurance at the Braunschweig site

Phone +49 531 6181-6200

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