FDA-registered sites declined in 2020: OPQ drug quality report

Regulatory NewsRegulatory News
| 17 August 2021 | By Kari Oakes 

A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) shows a small drop overall in drug manufacturing sites and a shift toward pandemic-related priorities in FY 2020.
The OPQ report on the state of pharmaceutical quality for FY 2020 notes that drug manufacturing sites included in FDA’s site catalog declined by just over 1% in FY 2020 to 4,221. Medical gas manufacturers are excluded from this figure, as are the crop of hand sanitizer manufacturers that sprang up in the COVID-19 pandemic’s early days.
FDA issued a guidance outlining its temporary policy for preparation of hand sanitizers as part of its pandemic response; the number of new hand sanitizer manufacturing registrants increased from 740 in 2019 to 6,743 in 2020, according to the report. However, 3,688 firms de-registered when FDA attempted to confirm registrants and the products they were producing.
The report details the efforts FDA took to address quality issues resulting from the large number of inexperienced hand sanitizer manufacturers, noting that Mexico was the subject of FDA’s first-ever country-wide import alert related to a human drug. (RELATED: FDA puts all Mexican hand sanitizers on import alert, Regulatory Focus 27 January 2021)
The pandemic also deeply affected OPQ’s ability to track manufacturing site compliance, though inspections deemed mission-critical continued. Mutual recognition agreements extended the reach of the agency, allowing assessment of 183 sites. In all, FDA inspected 745 sites in FY 2020, compared with 1,367 in FY 2019.
Warning letters rolled out despite the pandemic
Firms with non-application products garnered the largest proportion of warning letters associated with current good manufacturing practice (CGMP) violations issued in FY 2020, continuing a longstanding trend. Non-application products that are non-sterile and in finished dosage form accounted for 41% of the overall volume of letters.
As in FY 2019, the US had the largest number of sites logged in the site catalog maintained by the Center for Drug Evaluation and Research (CDER), followed by India, China, Germany and Canada. All countries lost more sites than they added in FY 2020. Among other top countries, Mesico lost the most sites (13%), while South Korea saw both large gains (32%) and losses (34%) of sites, “indicating its status as an emerging source of pharmaceutical products.”
The OPQ report notes that more sites (1,093) are manufacturing both innovative and generic products than manufacturing innovator (494) or generic (609) products alone; though the numbers differed slightly, this was also seen in FY 2019.
Machine learning predicts low site inspection scores
“A site inspection score (SIS), on a scale of 1 to 10, is used as a proxy for compliance with CGMP regulations,” explains OPQ in the report; a firm’s SIS is compiled with data from FDA’s drug quality assurance inspections over the past 10 years. The mean SIS decreased slightly in FY 2020 to 7.3, with highest mean scores seen in the US, the EU and Canada. China, India and Latin American all had mean scores below the global average “though the scores indicate an acceptable level of compliance to CGMP on average.” Homeopathic establishments brought up the rear for mean SIS scores in FY 2020.
In FY 2020, FDA employed machine learning techniques to see which features were predictive of higher or lower SIS. Profile class codes associated with test laboratories, lower product defect rates, higher numbers of new drug application (NDA) products, and being US-based were all attributes associated with higher SIS.
By contrast, India-based firms, those making analgesics but in low quantities, those manufacturing many different kinds of drugs, and those with no NDA listings were all more likely to have lower SIS according to the machine learning outcomes. Homeopathic sites and US- and India-based sites with a high number of physical product issues were also likely to have lower SIS.
Editor’s note: We will return tomorrow with analysis of drug quality issues and trends identified in the OPQ report.
OPQ Pharmaceutical Quality report


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