Drug Safety: A Major Worldwide Issue in Patient Protection

Abstract

ICH (International Conference on Harmonization) guidelines set the standards for stability, uniformity, and safety of pharmaceutical drug products. The German Central Institute for Drug Research is a service laboratory of the DiapharmGroup and ensures quality control of its products according to Good Manufacturing Practice (GMP) standards. To test for ICH stability standards for drug products, the institute uses BINDER KBF climate testing chambers to test for the best climatic conditions in accordance with guideline ICH-Q1A. Between 5 and 15 product batches can be stored concurrently in each KFB test chamber, where they are exposed to specific conditions for specific periods of time.

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