The CGI facility and operations are managed and documented under our cGMP quality policy. Our quality group oversees all aspects of our operations that could potentially impact product quality. Procedures are fully documented and all manufacturing and analytical data require a final review and approval by our quality group.
CGI conducts internal audits on a semi-annual basis and external service provider audits on a bi-annual basis. GMP training is provided on an annual basis for current employees and at the time of hire for new employees.
CGI is a FDA registered food manufacturing facility:
FDA Regulated and Inspected. Inspection Date: 08/09/16
CGI is currently applying for ICH Q7A active pharmaceutical ingredient manufacturing approval.