FDA Publishes Site-Selection Model for Inspecting Foreign Mfg Facilities

The US Food and Drug Administration (FDA) has published an internal policy that outlines the agency’s risk-based, site-selection model for inspecting foreign drug-manufacturing facilities and has highlighted other ways in which the agency is overseeing product quality at drug-manufacturing facilities.

“…[T]o add greater transparency around our site-selection model, we’re publishing our internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections,” FDA Commissioner Scott Gottlieb said in a September 5, 2018 agency statement. “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.”

Gottlieb says the FDA prioritizes inspections of sites regardless of their location, by using a risk-based site-selection model. 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, the FDA pursues opportunities to collaborate with other countries. Gottlieb noted in his comments that as of fiscal year 2017, there were about 5,063 human pharmaceutical sites worldwide subject to routine surveillance inspection with 3,025 of those foreign-based. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 of foreign sites.

Gottlieb highlighted other ways in which FDA oversees foreign drug-manufacturing facilities. In 2017, the FDA formed a mutual recognition agreement for manufacturing inspections with the European Union (EU) to enable the FDA to recognize drug inspections conducted by foreign regulatory authorities that meet US requirements.

Gottlieb says the agency has also taken steps to improve transparency through its public inspections database. “The agency recently updated its inspections classifications database, which provides the most recent classifications of inspections of manufacturing facilities conducted for routine CGMP surveillance purposes or inspections of sites conducting bioequivalence/bioavailability studies,” Gottlieb said in the statement. “The database provides transparency to the industry, the general public, and other regulators into the outcomes of recent observations. The database has also been updated to build on our progress implementing the Mutual Recognition Agreement with the European Union, and now supports inclusion of facility status based on classification of inspection reports from recognized foreign regulatory authorities.”

Gottlieb says the FDA has also enhanced its communications about inspections to facility owners to enable quicker resolution of situations where quality standards are not being met. For example, efficiencies from a Concept of Operations agreement the FDA implemented in 2017 have enabled the agency to communicate inspection classification information to facility owners within 90 days of the close of a surveillance inspection, says the agency. The FDA has also established procedures to notify applicants when it identifies issues during its premarket inspections that could impact approvability of a new drug application by communicating through an information request, discipline review letter. or complete response letter.

Gottlieb also noted that the agency’s practice of issuing guidance documents to help ensure product quality. For example, it provides guidance documents on a range of quality issues, from pharmaceutical development through commercial manufacturing and quality control, on original application submissions and on making changes after approval, addressing active ingredients and finished product. It also obtains drug samples and test drugs from various sources each year to evaluate aspects of quality that can be analytically measured and verified.

Source: FDA (statement) and FDA (published policy)

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