Drug safety – a central issue around protecting patients worldwide
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In this case study, you can read all about how Zentralinstitut Arzneimittelforschung GmbH joins forces with BINDER to perform stability testing in line with ICH in constant climate chambers from the KBF series. The ICH tests are an important component of the approval and registration of a product.
As well as tests for the approval/registration of drugs, on-going stability testing is becoming ever more important: it forms part of the continuous quality monitoring of drugs carried out as per Good Manufacturing Practice (GMP). The aim of these tests is to prove that a pharmaceutical product has the necessary stability (quality) throughout the proven shelf-life.
The remit was as follows:
- Methodology development
- Quality control to approve drugs
- Stability testing to approve and register as part of drug monitoring
- Reliability across the entire service life of the climate chamber
- Compliance with standards