Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Pharmaceutical Excipients – Regulatory and GMP Requirements ***

Dr. Sabine Schmitz (Abschlußjahr: 2007)

Language: English

Excipients are essential components of virtually every pharmaceutical product, although they do not have the therapeutic benefit of active pharmaceutical ingredients. They generally range from basic food ingredients to specialized functional chemicals. Many excipients are supplied by the basic food ingredient and chemical industry and others even come from remote primary sources, i.e. for most excipient suppliers the pharmaceutical industry is just a fraction of their total business. Many excipients come through extended distribution chains.

Considering the diversity of excipients, the different origins, sources and applications, it becomes obvious that excipients cannot just be treated as active substances, i.e. by applying the same regulations and restrictions, but at the same time, as with every substance administered to man, excipients need to be regulated and well-controlled. This dilemma calls for regulations specifically designed for pharmaceutical excipients.

In the present thesis, the current regulatory and GMP requirements for pharmaceutical excipients are discussed. The general information on excipients, the technical documentation and quality data that need to be submitted with a view to applying for or amending a related marketing authorisation for a medicinal product in the EU are summarised. Attention is paid to special excipients, like antimicrobial preservatives, antioxidants, solubilisers and permeation/ penetration enhancers and colouring agents for which additional requirements need to be considered. In addition the increasing regulatory demands for excipients from human or animal origin and for novel excipients, which have not yet been introduced to the market, are addressed.

Main focus is also on the upcoming changes in European regulations of excipients. Attention is paid to the impact of recent EC Directives for human medicines on the regulatory process, from licensing and GMP perspectives.

Pages: 44