Quality Update Peggy Yena | Vice President of Quality
I thought I’d start with a big thank you to everyone for your ongoing efforts to put excellence in everything you do and for partnering with the Quality team to continue to improve our processes. Putting quality first is a market differentiator and so important to BioCare’s Family of Brands. As part of putting quality first, we’re able to confidently state to customers and business partners that we are a current Good Manufacturing Practice (cGMP) facility. To maintain this designation, we must follow cGMP regulations that are enforced by the FDA. This takes effort on everyone’s part to maintain this status; we must follow our Standard Operating Procedures (SOPs) 100% of the time, we must have transparent reporting of SOP deviations or lack of SOPs to the Quality team, and we must partner with the Quality team to look for opportunities to continually improve our processes. In addition to our cGMP facility status, we have our Drug Distributor Accreditation (DDA) (fka VAWD) through NABP. A new addition to our DDA this year will be to complete a successful Supply Chain Inspection. The Supply Chain Inspection is unannounced which means the inspector will show up at our front door with no prior notification sometime in the next eight weeks. Lastly, we had five successful inspections in 2021 with no major deficiencies (Arizona State Board of Pharmacy, Vitalant Internal Audits, Alexion). As part of these audits, we showcased our Quality Management System (QMS) capabilities including a full audit of MasterControl. Preserving our cGMP status, maintaining our DDA and Supply Chain Accreditation, having successful audits, and working towards other future accreditations (e.g., ISO 9001), will continue to set us apart from our competitors. The Rees temperature monitoring system was successfully launched on February 2, 2022, replacing the legacy Plexxium system. I can confidently say that the Rees system is a huge improvement over the Plexxium system both in system capabilities and service. The SOPs and training are complete and Quality is currently partnering with BioCare and Vitalant IT to properly shut down the Plexxium system and store the historical data.
We continue to log CAPAs, Events, and Customer Complaints in the newly launched deviation management system within MasterControl. As we mature this module as part of our QMS, it will help us better track and trend deviations such as product recalls, withdrawals, cGMP variations, and other system events. We welcomed Jordyn Maher to the Quality team last month and will be expanding the team over the next several months to help accelerate BioCare’s key initiatives. Opening a 55,000 square foot Warehouse in Olive Branch Mississippi is just one of the key initiatives and we’ll be looking to hire an on -site Quality Ma nager for that facility. In addition, we’ll be looking to expand the team in Arizona. As BioCare continues to expand and grow in 2022, Quality will continue to be your partner to help in that growth to maintain a step ahead of our competitors by putting quality first!
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