Stability studies by Intertek



Following studies are carried by Intertek

Stability studies for stability chamber are an essential component of pharmaceutical development, allowing evaluation of active pharmaceutical ingredient (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.


It is important that you select an experienced stability study outsourcing partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real time, accelerated or forced-degradation study requirements. Stability testing can present significant analytical hurdles, with specialised knowledge required to develop and validate stability indicating methods and perform analysis of leachable substances which migrate from pharmaceutical packaging into the product.

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk in chambers, cabinets and refrigerated as well as freezer storage which are fully controlled and monitored with back up chambers at each site. All sites have 24 hour alarm systems with dedicated on call teams to react to the excursions from storage conditions. Our stability teams provide professionally managed Good Manufacturing Practice (cGMP) stability programs for even the most complex of dosage forms, APIs or product types including orally inhaled and nasal drug products (OINDP), biopharmaceuticals, consumer healthcare, medical devices or vaccines. We also offer a responsive and bespoke stability contingency and disaster recovery storage service to help you mitigate the risks associated with costly stability trials.

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