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
Stability study protocol preparation
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

8810 Rehco Road, Suite F, San Diego, CA 92121
Tel (858) 623-1520 Fax (858) 623-1525

IriSys' formulation development scientists and
cGMP manufacturing unit optimize the
formulation of clinical trial materials.