We will review your existing facility against regulatory requirements such as USP and FDA guidance documents and provide our professionally suggested next steps to meet the required standards.
An on-site inspection of existing compounding facilities will be performed to evaluate the parameters.
We will review the fit and finish of the facility, the layout of the facility for gowning and process flow, and the certification report will be reviewed and compared to site observations to ensure the primary and secondary engineering controls are appropriate and operating within acceptable parameters.
Facility GAP Reporting
Upon completion of your facility review, we will provide a detailed report of our findings.
This will include recommendations to address any areas that do not meet regulatory expectations.