Process Validation

Quality Control

For customers preparing for commercial approval, process validation is a critical and significant activity. CMC 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 Our system is based on the FDA’s 2007 Draft Guidance for Industry and consists of these basic stages and supporting studies.

  • QC_Lab_General_085_crop.jpgKey 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