Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

Key point summary:

In the June 2023 FDA Report, “Fiscal Year 2022 Report on the State of Pharmaceutical Quality,” from a GMP inspection and compliance perspective, of particular interest are that FDA conducted three times as many surveillance inspections in 2022 as compared to the 115 conducted in 2021, which included 129 inspection classifications under Mutual Recognition Agreements (MRAs) and 49 assessments based on FD&C Act section 704(a)(4) information requests.

Regarding compliance activities, FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites in FY2022, but nearly half were issued to hand sanitizer manufacturers. As in the past, the most cited CGMP issues related to the quality control unit. Of the 28 import alerts issued, 82% of them related to drug quality were for sites manufacturing hand sanitizer. The largest number of alerts were for sites that refused to respond to 704(a)(4) records requests or for GMP issues found during records reviews.

More detailed summary:

The June 2023 FDA Report, “Fiscal Year 2022 Report on the State of Pharmaceutical Quality,” summarizes the agency’s activities for FY 2022 in 18 pages, with sections on: manufacturing site and drug product demographics; import alerts, recalls, and warning letters; sampling and testing; and agency programs including the New Inspection Protocol Project (NIPP), Quality Management Maturing (QMM), and drug and biological reporting under the CARES Act.

From a GMP inspection and compliance perspective, of particular interest are:

• FDA conducted three times as many surveillance inspections in 2022 as compared to the 115 conducted in 2021, which included 129 inspection classifications under Mutual Recognition Agreements (MRAs) and 49 assessments based on FD&C Act section 704(a)(4) information requests.
• FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites in FY2022. Nearly half were issued to hand sanitizer manufacturers. The most cited FY2022 CGMP issues by FDA across all warning letters were related to the quality control unit, production record review/investigations, written procedures/deviations, equipment cleaning and maintenance, and testing/release.
• The number of manufacturing sites worldwide under the agency’s purview showed a net increase of 12% in FY 2022, with the top increases in India (17%), Spain (15%), the United States (13%), Switzerland (13%), and France (11%). The number of sites in China increased by 8%.
• Although 28 import alerts were issued, 82% of them related to drug quality were for sites manufacturing hand sanitizer. The largest number of alerts were for sites that refused to respond to 704(a)(4) records requests or for GMP issues found during records reviews.
• In FY 2022, 166 sites generated 912 recalls, which the agency notes is the highest number in five years. 230 of those were related to temperature issues.
• Regarding the supply of essential medicines, the report notes that the U.S. still has a high reliance on foreign manufacturing sites, with 82% of active pharmaceutical ingredient (API) manufacturing sites and 57% of finished dosage form (FDF) sites for those medicines located overseas.