Quality Control
Quality Control at Bionova
Bionova’s Quality Control group provides analytical support to all client GMP manufacturing programs and maintains a functioning, compliant facility.
Routine support includes:
- Method qualification and validation
- Standalone product quality assessment
- Upstream and downstream process support
- Raw material testing for GMP manufacturing
- Stability studies (accelerated and real time)
- Environmental Monitoring of GMP facilities and utilities
- Bridging studies and filing support
- Investigation testing support
Capability
Bionova’s Quality Control team maintains the same capabilities as our Analytical Sciences team’s broad assay repertoire, suitable for process effect screening studies, process optimization, comparability studies, defining Critical Quality Attributes for in-process and release testing, and final product stability evaluation. We then add raw material control, microbiology, and environmental monitoring capabilities for successful cGMP compliance.
Technology
Our Quality Control lab is equipped with an array of advanced instruments and equipment to support the diversity of testing our client’s demand. Our in-house Analytical Sciences team can work with our Validation team to accelerate identification, acquisition, and qualification of any new tools to get the job done.
Culture
We pride ourselves on our open culture. Bionova teams are client-focused: ready to collaborate with our client/partners and cross-functionally within Bionova to determine how best to achieve the program goals. We can perform risk-based method transfer and co-qualification with the Analytical Sciences team to accelerate program speed.
Stability
Bionova Scientific Quality Control team’s close coordination with the GMP manufacturing operations team allows for easy set-up for DS stability studies. DP stability studies are similarly supported through the deep project management capabilities at Bionova. Quality Control maintains continuously monitored, cGMP qualified stability chambers with the flexibility to adapt to various stability conditions. We manage stability studies electronically to ensure proper set-up, timely sample testing, and reliable data reporting.
