IriSys’ Quality Assurance Unit is responsible for regulatory
compliance as directed by the Federal Food and Drug Administration
(FDA). The QA Unit regularly provides cGMP training and internal
audits are conducted 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
