The suspension relates to two laboratories. The issue relates to the codified regulations relation to pharmaceutical medicinal products which are termed ‘Good Manufacturing Practice’ (invariably with a lower case ‘c’ applied to indicate the word current, and hence the initlaism ‘cGMP’ is commonplace.) In the U.S., GMP forms part of the Code of Federal Regulations (CFR) and it is enforced by bodies like the Food and Drug Administration.
Both laboratories form part of the NIH’s Clinical Center Pharmaceutical Development Section. One laboratory is a national Institute of Mental Health facility manufacturing positron emission tomography materials. The second facility is a National Cancer Institute laboratory producing cell therapies. Initial findings, relating to both facilities, suggested that the laboratories were not meeting the highest quality standards in relation to the production of sterile products, especially products that could be used for intravenous infusion.
These findings stemmed from an FDA inspection last year. The FDA inspectors found several areas of concern relating to aseptic processing. Aseptic processing is conducted in a cleanroom with a localised air supply. The air is passed through a High Efficiency Particulate Air (HEPA) filter at a fast speed, and the air is configured so it travels unidrectionally.
The FDA were concerned about the design of the facilities, especially with clean air control. The agency also picked up weaknesses with the microbiological monitoring program, which was not seen as sufficiently comprehensive in order to show any shifts in trends. There were also concerns about the level of cleaning (with detergents) and follow-up disinfection, using biocides.
While the suspension is underway, external companies have been engaged to review best practices and to recommend how manufacturing standards can be improved. The companies hired are consultancies called Work Buildings and Clinical IQ. The findings will help NIH to draw up a suitable corrective action plan.
The suspension has led to several clinical trials being postponed. One such company, according to Pharmaceutical Technology magazine, is Kite Pharma.
NIH stress that no patients were put at risk as a result of the findings and that no further clinical trials involving people will take place until suitable corrective actions have been taken.
