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FDA’s annual manufacturing report card shows more quality compliance is needed.
As schools in the United States close for the summer break, student grades serve as a measure of how well teachers shared knowledge, how well students understood and retained that information, and how the school, as a whole, performed year over year.
FDA recently issued a report card of the bio/pharma industry’s manufacturing quality performance. The Report on the State of Pharmaceutical Quality (1), issued in May 2019 by the Office of Pharmaceutical Quality in FDA, Center for Drug Evaluation and Research, assessed the ability of pharmaceutical manufacturers to deliver quality pharmaceutical products to the US market during fiscal year 2018. The report analyzed product recalls, quality defect reports, drug shortages, and application state (e.g., submissions, approvals, refuse-to-file, refuse-to-receive, and complete response letters) as a basis for its analysis.
The report examined manufacturing site data by geographic region, therapeutic category, application type, and manufacturing sector. FDA issues a site inspection score-on a scale of 1 to 10 with a higher number indicating greater compliance with current good manufacturing practices-based on FDA quality inspections over the past 10 years.
Of the 4676 sites in FDA’s catalog, 42% manufacture “no application” products, such as over-the-counter products, monograph, unapproved, or homeopathic products. The remaining 58% of sites manufacture application drug products (e.g., new drug application [NDA], abbreviated new drug applications [ANDA], biologic license application [BLA], etc.) and nearly half (46%) of these sites manufacture both NDA and ANDA products.
The report noted “volatility” in the site catalog in the past year; the agency removed from the catalog “a large number” of sites in India, China, and South Korea in FY2018 because they did not make products for the US market and, therefore, did not have to be registered with FDA. This indicates “a lack of understanding of the registration and listing requirements,” FDA noted in the report. The agency also reported a 32.8% net increase in the number of packaging and labeling sites-suggesting an increase in outsourcing of these functions.
Less than 40% of the drugs for the US market are manufactured in the US. India (12%) and China (11%) are the two largest offshore suppliers. FDA also noted that a small number of sites are responsible for manufacturing a large number of listed products; the number of products manufactured at a site is a risk factor used in prioritizing the need for surveillance inspections. In the US, three sites-two of which make homeopathic products-account for 9.5% of all products listed by all US sites. The number of listed products manufactured by the top three sites in China (11.2%) and India (12%) are even higher.
In FY2018, FDA conducted 1346 drug quality inspections, covering less than one-third of sites in its catalog. More than half of the inspections were outside the US. The average inspection score of 7.5 for FY2018 was down slightly from FY2017 (7.7). Sites in the European Union (7.9) and the US (7.7) scored higher than average; sites in China (7.0), India (7.0), and the rest of the world (7.2) were lower than average. Statistical differences were also noted in application areas, with sterile non- application products as one of the lowest performing.
FDA noted “… some trends highlight opportunities for increased outreach to, surveillance of, and enforcement of certain markets,” indicating that for regulated drug manufacturing, school is never out.
1. FDA, Report on the State of Pharmaceutical Quality, May 13, 2019.
Vol. 32, No. 6
When referring to this article, please cite it as R. Peters, “Bio/Pharma Facilities Still Have a Lot to Learn," BioPharm International 32 (6) 2019.