The service laboratory Diapharm Analytics, a Tentamus company, assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.
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 authorisation. 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.
Medicinal products and medical devices in multidose containers face a higher risk of contamination or degradation due to repeated opening, which is why a shelf life after first opening is given for these products. This shelf life is determined as part of in-use stability testing. Testing entails simulating actual use, such as everyday usage of the package, tube, spray can, applicator etc., as closely as possible. The product is inspected at specific intervals with regard to microbial, chemical and physical attributes.
Proof of the opened product’s quality is part of the marketing authorisation documents. In the process, it is necessary to prove in-use stability both at the beginning and at the end of the specified shelf life. Testing must therefore be devised at the same time as ICH long-term stability testing in order to prevent any loss of time.
The requirements of in-use stability testing are described in the CPMP Guideline CPMP/QWP/2934/99 from the European Medicines Agency (EMA). The guideline does not prescribe a specific test design. The design depends on the product’s use and packaging. Diapharm Analytics can help you create a needs-based testing plans and is happy to advise you on batch selection.