42% of FDA Drug Quality Inspections Done in U.S.
A new FDA drug quality annual report says that FDA in 2019 performed 1,258 drug quality surveillance inspections, with 42% of these conducted in the U.S. Inspections in the European Union were next on the list with 17% conducted there, followed by India (15%), China (9%) and the rest of the world (17%). FDA’s surveillance benefited from its Mutual Recognition Agreement (MRA) with the European Union (EU) that allows regulators to recognize reports from their counterparts’ drug quality surveillance inspections conducted within their own borders. “In addition to the inspections performed by FDA inspectors, there were 109 drug quality inspections performed by EU investigators that were reviewed and classified by the FDA under the MRA,” the report says. “The collective inspections by FDA investigators and EU investigators under the MRA provided coverage of 32% of the total global site catalog in FY2019. The growing ability to rely on the MRA enables the FDA to allocate its resources elsewhere by conducting an increasing percentage of inspections in other parts of the world.”
The report says that most inspection observations (58%) were related to records and reports, laboratory controls, and equipment. “The most cited sections were related to 211.192 (Production Record Review, 8%), 211.22 (Responsibilities of the Quality Unit, 8%), and 211.160 (General Requirements / Scientifically Sound Laboratory Controls, 5%),” the report says. “These sections represent some of the key elements of an effective pharmaceutical quality system. These are potential areas of focus for manufacturing facility management to improve overall pharmaceutical quality and inspectional outcomes.”
FDA also says that immunological products continue to be significantly overrepresented in product quality defect reports. “Though these products represent only 2.1% of all approved applications, they account for 19% of all product quality defects reports,” the agency says. “Two popular immunological products, considered combination products, account for most of the product quality defects reported for this class. “Many of these issues relate to the device constituent part. Notably, both immunological products showed a decrease in the number of reports submitted beginning in early FY2018 and continuing into FY2019. This trend could be due to several FDA-approved changes to the devices, labeling, and assembly sites.”
Additionally, the report touches on FDA’s Emerging Technology Program that promotes the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, industry reps can discuss with FDA potential technical and regulatory issues prior to filing a regulatory submission. Continuous manufacturing, according to the agency, is an important emerging technology that eliminates breaks between steps during drug manufacturing to reduce errors related to stopping and starting of a process. “In FY2019 significant work went into the eventual approvals of three applications as part of the Emerging Technology Program, including a continuous manufacturing process for the active ingredient used in an inhaler,” the report says. “This continuous manufacturing process was the first ever approved for making an active ingredient.”