cGMP Core Quality Control Laboratories

Daniel Kota, PhD

Director, Office of Translational Production & Quality

Director, cGMP Core

Gerard Baham

Quality Control Chemist, Office of Translational Production & Quality

Quality Control Laboratories

Our on-site quality control laboratories provide testing and release for manufactured products with strict adherence to FDA requirements. These tests confirm the quality, identity, purity and strength of the manufactured drugs in order to ensure that we deliver a safe and effective product to our patients.

Services:

• Endotoxin Testing
• Environmental Monitoring
• ICH Stability Storage and Testing
• Inorganic Impurities Testing
• Method Development and Validation
• Organic Volatile Impurity Testing
• QC (batch release) and Raw Materials Testing
• Temperature Mapping
• Water Analysis