Quality Assurance

cGMP Manufacturing Protocols and Quality Assurance

IriSys’ Quality Assurance Unit is responsible for regulatory compliance as directed by the Federal Food and Drug Administration (FDA) according to Title 21 of the Code of Federal Regulations. The QA Unit regularly provides cGMP (Current Good Manufacturing Practices) training and conducts internal audits to ensure day-to-day cGMP compliance of the Quality Systems. The QA Unit provides final review and approval of the following documents.

• Protocols
• Standard Operating Procedures
• cGMP manufacturing batch records
• Specifications
• Final product release and Certificates of Analysis
• Stability study testing data
• Compliance audits
• Formal reports