Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.
The FDA prioritizes inspections of sites regardless of their location. For manufacturing facilities in other countries, inspections may be conducted by staff in foreign offices, those on temporary duty assignments, or staff that travel internationally to conduct the inspection. In addition, to maximize resources and efficiency, we’ve also pursued opportunities to collaborate with other countries.
The FDA’s inspections program is a large-scale endeavor. As of Fiscal Year 2017, there were about 5,063 human pharmaceutical sites worldwide subject to routine surveillance inspection – 3,025 of those were foreign-based. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 on foreign soil, to ensure manufacturers were following Current Good Manufacturing Practice (CGMP) requirements and maintaining high quality standards.
In addition to identifying the facilities of greatest risk and prioritizing those inspections, the FDA has also made efforts to ensure our resources are effectively deployed to address inspection demands.
Following each inspection, the FDA assesses the significance of the findings leading to a final classification into one of three categories – no action indicated, which means the agency found no objectionable conditions during the inspection; voluntary action indicated, which means the agency found objectionable conditions, but we are not recommending regulatory action at this time; or official action indicated, which means the agency found objectionable conditions and may pursue regulatory action.
FDA carried out these updates well ahead of our scheduled commitment under the reauthorized Generic Drug User Fee Amendments (GDUFA II) to perform the updates by 2019.
In addition to these efforts, cooperation and harmonization with other foreign regulators are critical to ensuring that the drug supply produced outside the U.S. meets our safety and efficacy standards. To advance these goals, we participate in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which focuses on harmonizing how inspections are conducted.
