Quality Assurance has the scope to guarantee that medicinal products meet the requirements of authorized quality standards. To achieve this goal, Quality Assurance has the responsibility to establish a Quality System able to monitor and control any sensitive area of the process.
Quality Assurance is a critical component of our workflow, ensuring that our projects and production runs are rigorously examined to match the stringent quality standards required by various government agencies. In order to do so, our team has developed detailed protocols and practices designed to improve and streamline the process, while maintaining transparency and complying with all regulatory guidelines from major agencies.
Our Quality Management System is ready to support the programs of our clients, monitoring performance to guarantee a constant level of quality over time. It is compliant with the current GMP and regulatory guidance provided by EMA, AIFA, FDA, and other local governmental entities.
We understand the value of your project, and the importance of producing the highest quality clinical lots. Therefore, our main goal is not just to ensure that stringent quality standards are applied to any of our production runs, but to identify areas for further improvement at any stage of the process.
Our Quality Assurance unit will review and study all aspects associated with the quality of your project, providing you with a robust data package and peace of mind.
Our capabilities include:
- Supplier qualification
- Raw materials release
- Deviations and change control management
- CAPA planning and execution
- Batch record reviews
- Product quality review and trend analysis
- Risk management
- Batch release
- Labelling of IMP and release to the clinical site
- Personnel training program
- Handling of complaints, recall and returned products
- Management of validation activities
- Internal audit and self-inspection