Clean Room Lessons from FDA’s Compounding Pharmacy Inspections
This article was originally published in The Gold Sheet
Reacting to last fall’s fungal meningitis crisis, FDA has inspected more than 50 compounding pharmacies this year looking for poor aseptic practices. What it found makes for a sobering training tool on sterility assurance.
You may also be interested in...
As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.
Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.
A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.