The Fiscal Year 2023 Report on the State of Pharmaceutical Quality

The FDA publishes yearly their report on the State of Pharmaceutical Quality, focusing on events which took place within the previous fiscal year. The sixth and latest report covers the period between 1-Oct-2022 and 30-Sep-2023 and was produced by the office of Quality Surveillance which belongs to the FDA Office of Pharmaceutical Quality.

The goal of the report is to provide insights into the quality of the U.S. drug supply and pharmaceutical manufacturing, which has been a topic of ongoing political discussion, as reflected by the letter that 2 U.S. senators sent to the FDA earlier this week. The letter urges the FDA to set clear standards and develop dedicated industry guidance to promote the adoption of advanced manufacturing technologies and therefore strengthen the American domestic pharmaceutical supply chain.

The main quality topics covered within the report include:

1. Drug shortages – a major issue which was caused mostly by quality issues as well as increased demand. Based on the revision of the ICH Q9 we have provided here a good overview on how risk-based approaches can help tackle drug shortages due to quality problems and we also hosted a webinar which you can check out

2. Inspections – FDA conducted during this period ~42% more inspections compared to the same period of the previous year, with UK and Canada being the only two counties where inspections were reduced. Increasing collaboration between the agency and MHRA and Health Canada might be one of the reasons behind this. The countries were FDA increased the most its inspections were Mexico, China and South Korea

3. Recalls – went down 26% from those of 2022 and more than half of them were related to GCMP deficiencies. Interestingly 13% of recalls over the examined period were attributed to a single manufacturer that was unable to maintain CGMP requirements for distributed drugs as they went out of business whereas ~10% of recalls were attributed to a single drug manufacturing site for Data Integrity issues identified during an inspection. This latter highlights the importance of quality audits before selecting suppliers which should focus among others on the evaluation of Data Integrity topics in their systems and processes

4. Import alerts – 93 new companies were added to the FDA import alert list with most of them being related to drug quality issues and 90% of manufacturing sites being producers of OTC products

For more information regarding the published report visit: https://www.fda.gov/media/179254/download?attachment

If you need support with implementing a risk-based approach in your company to increase product quality and prevent supply chain issues, contact us: https://www.gxp-cc.com/contact/