Stability testing of medicinal products

Authority representatives and pharmaceuticals experts from Europe, the USA and Canada recently discussed current experiences with the stability testing of medicinal products in Vienna, Austria. The conference, titled Stability Testing for Pharmaceuticals, focused both on questions of interpretation of the guidelines on which the testing is based, and on specific proposals for the implementation of testing.

Jurgen Mahlitz of the Upper Bavaria medicines authority gave a presentation on the expectations and experiences of a Good Manufacturing Practices inspector in respect of ongoing stability testing. Sven Oliver Kruse of the German pharmaceutical service provider Diapharm explained how these requirements can be put into practice in a focused and economical way. Since June 2006, pharmaceutical companies in Europe have been required to monitor the stability of their medicinal products during the marketing phase in a continuous program. The initial findings from this experience were discussed at the conference.

Globalization too is having an ever greater effect on the stability testing of medicinal products: "If products are manufactured and sold in different countries, the laboratory work must be planned so much more precisely - in particular in the definition of the climate zones which have to be taken into account," reported Dr Kruse. Some 50 employees from authorities, laboratories and research and registration departments of pharmaceutical companies took part in the conference.