FDA Makes Clarifications About Making Inspection Results More Visible to Public
September 16th, 2018 // 3:55 pm @ jmpickett
In early September 2018, FDA published new information about how it chooses and schedules drug manufacturing plant inspections all over the world, and the process that it uses to release the findings of those actions. FDA states that the more international nature of the pharmaceutical supply chain is making the agency revise how it does its inspections. It also is trying to harmonize US standards and those for foreign regulatory bodies to ensure drug quality.
FDA Commission Scott Gottlieb on Sept. 5 outlined several actions the agency is taking to ensure better drug quality for all manufacturers. He stated that the agency is making serious efforts to update its field inspection program by reorganizing its Office of Regional Affairs to make a better alignment with the expertise of its staff with key inspection priorities. It also is trying to expand the oversight of drug manufacturers overseas.
Experts in the industry note that it is not surprising that FDA is stressing more scrutiny of foreign drug manufacturers. In recent years, there was the case of the uncovering of dangerous impurities in a common API that was made in China. There also was a huge recall of valsartan, which is a common drug to treat hypertension. Several drug manufacturers detected a chemical that could cause cancer – NDMA – in the API made in China. FDA testing of these pharmaceuticals also showed another impurity – NDEA or N-Nitrosodiethylamine.
FDA noted that in addition to doing more risk based inspections for companies that are more problematic, the FDA is also making efforts to make audit results more visible to everyone in the public. The purpose is for the agency to be more transparent about its inspection outcomes and compliance problems. This is especially the case when FDA finds violations of the FD&C Act that could require more FDA action. For example, FDA has updated the inspections classifications database to give more recent data about the results of GMP inspections. this is in support of the EU MRA by adding audit reports from regulatory authorities in Europe and other parts of the world. Access to current audit reports will allow FDA and other drug regulators to more effectively issue FDA warning letters, import alerts, and drug recalls to avoid repeated FDA violations.
The agency also is trying to improve the process to communicate FDA audit findings to facility owners to ensure there is faster resolution of any GMP failings. FDA officials are trying to provide audit classification information to drug companies within three months of closing the inspection. This is much faster than previously done. FAD also wants to alert firms that are trying to get new drugs approved when problems are identified during premarket drug inspections that could complicate approval of the application.
