ICH Pharmaceutical Stability Testing and Storage

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, covering all ICH stability conditions. These are fully controlled and monitored with back up chambers at each site. All ICH stability testing 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) ICH stability studies 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 stability storage outsourcing and stability contingency storage services to help you mitigate risks associated with costly stability trials.

GMP Stability Services:

• cGMP registration stability programs
• Protocol design and program management
• Development and validation of stability indicating methods
• Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, clinical trial materials, formulated products
• Tailored reporting (timepoint and final reports)
• Temperature cycling, freeze-thaw study and shipping studies
• Stability contingency and disaster recovery storage
• Stability storage outsourcing
• Forced degradation testing
• Real time stability testing
• Long term stability testing
• Intermediate stability testing
• Accelerated stability testing
• In use stability testing
• Follow-up stability trials
• Formulation stability testing
• Biologics stability studies
• Specialist expertise for OINDP stability programs
• Extractables / leachables