Quality Management
Ensuring quality, risk mitigation, and seamless project execution
To enable our scientists to focus fully on delivering exceptional project results for our clients, they are backed up by the Quality Management & Process Transfer team, which ensures regulatory requirements are met and consistent quality is maintained.
A comprehensive set of Standard Operating Procedures (SOPs) provides the foundation for achieving project objectives and ensures reproducible and comparable results. In addition, the Quality Management & Process Transfer team ensures that all documentation requirements are met, enabling the success of innovative projects and process transfer.
Quality Management & Process Transfer
- At the start of each project, we conduct a risk analysis and pre-mortem with a team of experts, proactively identifying and eliminating potential obstacles from the outset.
- During project execution, we support the qualification of suppliers and the selection of raw materials, considering both their suitability and availability at production scale within the relevant regulatory framework.
- Project-specific methods and processes are documented and made available for technology transfer to customers, external CDMOs or within the BRAIN Biotech Group.