The US Food and Drug Administration (FDA) on Wednesday released an internal Manual of Policies and Procedures (MAPP) on how pharmaceutical manufacturing sites are prioritized and selected for surveillance inspections.
The release of the 7-page MAPP comes as FDA’s inspections program in Fiscal Year 2017 had to decide what sites to inspect from about 5,063 human pharmaceutical sites worldwide, 3,025 of which are outside the US. In 2017, FDA conducted 1,453 inspections, including 762 on foreign soil, to ensure manufacturers were following Current Good Manufacturing Practice (CGMP) requirements.
“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,” FDA Commissioner Scott Gottlieb explained
According to the MAPP, the Office of Surveillance, within the Office of Pharmaceutical Quality, is responsible for producing CDER’s Site Surveillance Inspection List (SSIL) that prioritizes sites for surveillance inspections.
The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act
The SSM will use risk factors consistent with section 510 of the FD&C Act, which identifies specific risk factors and allows FDA to determine additional ones, including: “a) The compliance history of the establishment. b) The record, history, and nature of recalls linked to the establishment. c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.”
The agency also uses its Mutual Recognition Agreement
to coordinate with the EU on which drug inspections need to be conducted. “In doing so, we’re able to dedicate more of our investigators’ time to those sites that pose the greatest risk,” Gottlieb noted.