Quality Control
For customers preparing for commercial approval, process validation is a critical and significant activity. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you a straightforward path through process validation. Our system is based on the FDA’s 2007 Draft Guidance for Industry and consists of these basic stages and supporting studies.
Key Process Validation components- Identification of Critical Quality Attributes
- Risk assessments
- Identification of Critical Process Parameters
- Process Control Strategy
- Bench-scale model qualification
- Bench scale characterization/DOE studies
- At-scale conformance campaign
- Continuous Process Validation Plan
- Supporting Validation Studies
- Raw material qualification
- Assay validation
- Cell line qualification
- Hold studies
- Resin/membrane lifetime
- Mixing validation
- Facility/utility/equipment qualification
- Extractables/leachables
- Impurity clearance
- API freeze/thaw studies
- API shipping validation
