We are able to design, manage and conduct stability testing in order to support regulatory submission.
- Develop methods to test active substance stability
- Analytical testing of active substance
- Observe effects of environmental factors: Light, temperature and humidity
- Statistical analysis of results
- Evaluate storage solutions for active substance
Project validation is assessed using Quality Risk Assessment strategies in order to determine critical stages in the process and analysis. Equipment used within a critical stage is qualified before validations are undertaken. The scope and level of process validation will depend upon the number of batches of materials to be manufactured.