Verbesserung der Bewertbarkeit von Transportabweichungen bei Arzneimitteln durch Transportsimulation
Dr. Malte Klemt und Dr. Guido Radtke
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
Korrespondenz: Dr. Malte Klemt, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein (Germany), e-mail: Malte.Klemt@boehringer-ingelheim.com
Improvement in the Evaluation of Drug Transport Deviations by means of Transport Simulations
Drug transport is subjected to very variable climatic and mechanical loads. This is why laboratory stress tests, qualification of the transport systems used and conduction of verification transports has limited suitability for reliably predicting the influence of all negative effects that can be realistically expected. In accordance with regulatory requirements, a negative effect on the quality of the drugs must be excluded even under unfavourable transport conditions. To provide proof, the present study simulated in contrast to conventional transport validation handling errors, vibrations and climatic loads that could be realistically expected in the identified distribution chain of the drug in a largely standardised manner. This allowed information to be obtained with particular emphasis on drug transport stability beyond the scope of laboratory stress tests, stability studies and transport validation.
Key words AMWHV • Arzneimitteltransporte • Transportabweichungen • Transportsimulation • Transportvalidierung
pharmind 2011, Nr. 6, Seite 1129