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Stability studies

Storage of active substances and drug samples for ongoing stability studies as well as stress tests of narcotic products according to ICH guidelines

We offer storage of test samples to monitor quality and shelf life of your active ingredients, intermediates and finished products over the study duration. This offered service is compliant with temperature guidelines according to ICH Guidelines among conditions of the Narcotic Drugs Act (BtMG) in the strong rooms.

The implementation of ongoing stability studies has been compulsory since the addition to Chapter 6 of the EU GMP Guidelines of 1 June 2006: Each year, one batch of each pharmaceutical product in each marketed primary packaging material must be stored and analyzed at fixed timepoints under controlled conditions (ICH, respectively CPMP/QWP/122/02).
The storage is carried out in modern climatic chambers under climatic conditions at 25 °C ± 2 °C / 60% ± 5% RH and/or under stress conditions at 40 °C ± 2 °C / 75% ± 5% RH.

Naturally, climatic conditions are continuously documented over the entire period of time by EDP.

We will be pleased to submit an offer.

Your contact partners are Mrs. Dr. Sylvia Gerke and Mr. Dr. Helge Pesel.