ICH Stability Testing
Products & Services
Information
With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of ich stability zones including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability storage 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 conducted according to ICH stability guidelines such as ICH Q1A (R2). We are experienced across all dosage forms product types such as 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
ICH stability 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 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
