The laboratory QSI GmbH, assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through in-use stability studies and stability monitoring of post-marketing batches (on-going stability testing).
QSI GmbH services:
• Storage according to ICH conditions
• Licence acc. to section 3 of the German Narcotic Drugs Act
• Coordination, analysis, evaluation and reporting
• Efficient planning and implementation of on-going stability studies
• Interpretation of OOx results (OOS, OOT, OOE)
Stability testing is required in order to determine and validate the chemical and physical shelf-life under specific storage conditions (humidity, temperature). In the run-up to clinical studies, stability testing is used to ensure that the shelf life of a study drug is sufficient to last for the duration of the study. Long-term studies involving the finished product are required for marketing authorization. Following this, manufacturers are legally obliged to undertake on-going stability studies on a regular basis, so that they are able to prove that the medicinal product in question can be used safely over the entire period of its shelf life.
ICH climatic zones for stability testing
No lifecycle without stability testing! The “expiry date” of a medicinal product not only supports the safe use of this product, but it can also open up new markets, for example, creating overseas opportunities.
• Climatic zone II, 25°C/60% RH
• Intermediate conditions, 30°C/65% RH
• Accelerated testing, 40°C/75% RH
• 2°C to 8°C