Shaun Noorian, founder and CEO of Empower Pharmacy, told us the company spent more than two years planning, designing, and constructing the new facility to meet current Good Manufacturing Practice (cGMP) requirements.
“We established a system to report adverse events and provided the FDA with a list of all the drugs we compound as part of our voluntary registration as a 503B Outsourcing Facility,” he added.
The new facility includes a 24-square-foot GMP lyophilizer (freeze dryer) with CIP/SIP (clean in place/sterilization in place) system, a 200-square-foot ISO-5 suite, and a 300-square-foot USP 800-compliant hazardous drug cleanroom.
It also features an environmental monitoring system and a fully automated sterile processing line capable of cleaning, sterilizing, filling, stoppering, and capping vials at a rate of 60 vials per minute
The new facility currently employs 65 – a number which is expected to reach 110 by September 2018.
Noorian said one driver of the company’s growth has been its reputation, and the shrinking market of sterile compounders.
“Numerous compounding facilities have either been shut down by the FDA or state boards of pharmacy, while others have decided to cease sterile drug operations due to the additional cost associated with new state and federal regulations,” explained Noorian, who expects this pattern to continue.
As Outsroucing-Pharma.com previously reported in February 2015, the FDA proposed new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.
“So, I believe that investing in quality systems is the best strategy for long-term viability in this market,” explained Noorian.
“When it comes to compounded medications that get injected into the body, there is no such thing as ‘good enough,’” he added. “Quality must be assured in every single dose.”