ICH Stability Testing and Storage
PharmSky can perform stability studies according to ICH guidelines to monitor the physical, chemical, biological, and microbiological attributes of products stored under accelerated and real time conditions over a defined period. This data is used to make decisions on material storage conditions, shelf life and labelling requirements and forms a critical component of regulatory submission documentation both before and after registration.
Stability studies are required at various stages throughout a products life cycle, including:
- Stability of drug substance before, during and after registration.
- Formulation screening during formulation and process development.
- Stability to support the life cycle of a clinical trial.
- Stability of exhibit and registration batches to support product registration.
- Surveillance monitoring of the product during its commercial life cycle.
PharmSky can support and manage the GMP stability testing of your product. We offer a wide range of TGA certified and ICH compliant stability storage and testing services, including:
- Stability protocol preparation, sample storage and program management.
- Stability testing of drug substances, excipients, and drug products for clinical, registration and surveillance purposes.
- Stability-indicating method development and validation.
- Photostability and stress testing.
- Extractables and leachables testing.
Our storage chambers have been qualified in alignment with regulatory requirements and are continuously monitored to ensure they stay within required limits. Stability programs can be undertaken under the following storage conditions.
- -20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60 ± 5% RH
- 40°C ± 2°C / 75 ± 5% RH
Contact Us Today
Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
