FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

            On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards[1]. Currently, there are over 5,000 pharmaceutical sites worldwide. Of these sites, over 3000 are based outside of the United States. This large number of ex-U.S. sites requires a regulatory scheme that ensures both Current Good Manufacturing Practice (CGMP) and transparency regarding drug manufacturing.

             As part of its push for transparency, the FDA released a manual of internal policies and procedures describing how manufacturing facilities are prioritized and scheduled for surveillance inspections[2]. In the September 5, 2018 press release, the FDA stated, “Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.”

            Apart from the actions reported in the September 5, 2018 press release, the FDA has taken steps to increase cooperation with foreign regulatory authorities to focus on facilities posing the greatest risk. Through the Mutual Recognition Agreement with the European Union, the FDA will recognize foreign regulatory authority drug inspections that meet U.S. requirements[3]. Additionally, the FDA has adopted a new organizational structure focusing resources based on specialization rather than geographic areas. 

             As part of the process described above, the FDA has updated its inspections classifications database and improved communications regarding inspections to facility owners[4].  As set forth in a Concept of Operations Agreement instituted last year, the FDA is able to disclose inspection classification information to facility owners within 90 days of the close of a surveillance inspection[5].    

            Additionally, the FDA states that it participates “in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which focuses on harmonizing how inspections are conducted.  We also participate in the International Council for Harmonization (ICH), which is a global body established to facilitate international collaboration that’s been successful in standardizing and elevating drug development practices and quality standards throughout the world”[6].

            Finally, the FDA stated that they are committed to aiding advanced manufacturing practices[7].  These practices foster “innovative, consistent and dependable manufacturing of drug and biological products.”