NIH Suspends Research in Sterile Production Facilities

Updated April 21, 2016

The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.

In its statement, NIH said it has hired Work Buildings and Clinical IQ, companies specializing in quality assurance for manufacturing and compounding, to review quality procedures in its Clinical Center Pharmaceutical Development Section (PDS) facilities. Preliminary findings by the companies determined that NIH’s PDS facilities are not in compliance with quality standards for the production or sterile or infused products. In response, NIH has suspended production in a national Institute of Mental Health facility producing positron emission tomography materials and a National Cancer Institute laboratory producing cell therapies.

This comes after an FDA inspection in May 2015 citing several safety concerns with the facilities’ aseptic processes. In June 2015, NIH responded to FDA’s observations, saying it planned to hire a contracting firm and organize an outside group of advisors experienced in CGMP regulations in order to evaluate PDS operations and recommend potential improvements. NIH also submitted a corrective action plan to FDA, in response to an inspection of NIH facilities completed by the agency in late May 2015.

In its interim corrective action plan, NIH responded to 17 of FDA’s investigational observations. Some of these observations include an inadequately designed air system in aseptic processing areas, a deficient system for monitoring environmental conditions in aseptic processing areas, and an improper system for cleaning and disinfecting the equipment to produce aseptic conditions.

As a result of the shutdown, several companies had to pause clinical trials being conducted in NIH laboratories. Kite Pharma issued a statement saying that their trials were among those suspended.

No patients have been harmed as a result of the quality issues, NIH said in its statement. NIH said it plans to undergo a “rigorous review” of the facilities and no new patients will be enrolled until all issues are resolved.

Source: NIH