Quality Control

cGMP Manufacturing Quality Control Unit

IriSys maintains a cGMP compliant Quality Control Laboratory. The Quality Control Unit is responsible for the following activities:

• Analytical methods transfer
• Release testing of bulk materials
• Release testing of API
• In-process testing
• Release testing of drug product
• Certificate of Analysis
• cGMP formal stability study program protocols and testing according to ICH Guidelines
• Analytical methods qualification
• Analytical methods validation
• Dose verification analysis of animal study materials
• Dose verification analysis of clinical trial materials
• Photostability study testing
• Dissolution study testing