Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New developments regarding regulatory requirements for stability testing in the European area

Dr. Lars Möllmann (Abschlußjahr: 2013)

Summary

Stability studies are one of the most important tools for the pharmaceutical development and the quality control during the life-cycle in order to ensure and to verify the quality and the consistency of active substances and the related finished medicinal products for human use. Because of the importance of the stability data a huge number of regulatory guidance/requirements were published in form of ICH and European guidelines, which deal with the planning, execution and analysis of the stability studies. This guidance is supplemented by a variety of different documents of the regulatory agencies/working parties. The outcome of stability testing should demonstrate that the quality characteristics (e.g.: assay etc.) of the observed products remain constant in relation to the release specification over a definite timeframe respectively should demonstrate, which environmental elements may have an impact on the quality of the product. Stability testing is not only a key point for a lot of regulatory activities as it is mentioned above, but also causes high costs. Due to the constant increase of economic pressure pharmaceutical companies are forced saving costs. Therefore, stability studies should be planned carefully and sensible. The analysis and the planning which studies have to be carried out is one important task for regulatory departments and should be based on the current and the prospective regulatory framework.

The objective of this master thesis was to give an overview about the latest developments regarding the regulatory requirements for stability testing of finished medicinal products for human use and their related active substances in the European area. New or updated regulatory guidance of the years 2010 until 2013 for stability testing have been presented and evaluated. The focus was in particularly on chemical-defined and herbal medicinal products. All innovations and revisions of the previously mentioned regulatory requirements have been highlighted and discussed. For all news the impacts and some upcoming potential problems have been presented for the daily regulatory work and suggestions for the respective solutions have been mentioned in the discussion to each subchapter. In the discussion the main benefits and disadvantages have been highlighted and notes are given, especially for the life-cycle management of authorized medicinal products and their related active substances.

Pages: 27
Annexes: 0