cGMP and USP 797/800 facilities
In 2017, ASE began working with Wells Pharmacy Network, a privately held compounding pharmacy with facilities in Florida and Tennessee. Wells Pharmacy has both 503A and 503B compounding facilities which are required to comply with both USP 797/800 and cGMP requirements. They reached out to us because they were experiencing deficiencies in their buildings and were not meeting the proper temperature and humidity requirements. Below is a short summary of the projects we have already completed as well as the project currently in progress.
Well Pharmacy 503A Facility – Ocala, FL
ASE provided a full system audit at the 503A facility in the winter of 2017. We provided report and recommendations, along with a cost budget to bring the facility up to USP 797 requirements. The owners approved the design and installation of a custom built Pharma Dry Air Unit, which was installed in the summer of 2017.
Wells Pharmacy Compounding Facility – Tennessee, FL
ASE performed an assessment of Wells’ Compounding facility in Dyersburg, Tennessee, in the spring of 2017. The facility was not meeting the desired and required temperature and humidity levels, including in the sterile processing and pellet processing areas. We studied the building, determined the reasons for deficiency and provided a report and recommendations to the owner to correct those deficiencies.
Well Pharmacy 503B Facility – Ocala, FL
ASE is currently providing architectural, HVAC, and fire protection design for the Florida 503B facility that must meet USP 797/800 and cGMP requirements. The pharmacy and laboratory rooms are being redesigned in order to meet the temperature and humidity requirements for a compounding facility.
13555 Automobile Boulevard, Suite 330
Clearwater, FL 33762
Advanced Systems Engineering, Inc. Copyright 2019. FL COA #8468. P.E. #51871