Process Validation
We offer a scalable process in order to help you prepare the clinical supply needed for commercial approval.
For customers preparing for commercial approval and post-commercial approval, Process Validation is a critical and significant set of activities. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you with a targeted path through late-phase Process Validation. Our systems are based on the FDA’s Approved Guidance for Industry and ICH guidelines, using a risk-based lifecycle approach, and consist of three basic stages with supporting validation activities.
Stage I
Process Design
- Identification of Critical Quality Attributes and Critical Process Parameters
- Risk assessments
- Process Control Strategy design
- Bench-scale model qualification
- Bench-scale process characterization / DOE studies
Stage 2
Process Performance Qualification (PPQ)
- At-scale PPQ campaign
Stage 3
Continuous Process Validation Program
Stage 4
Supporting Validation Activities
- Mixing and Hold Time Validation
- Extractables & Leachables
- Impurity Clearance
- API Freeze / Thaw Studies
- Resin/Membrane Lifetime Validation
- Virus Clearance Validation
- Raw Material Qualification
- Analytical Method Validation
- Cell Line Qualification
- Facility / Utility / Equipment Qualification
- API Shipping Validation