Pharmaceutical Industry: FDA Data on the Level of Quality

FDA's CDER Office of Pharmaceutical Quality (OPQ) has published a report on the state of pharmaceutical quality - and the results are mixed. However, if one takes a closer look, many of the problems stem from the increased production and distribution of hand sanitizers and products contaminated with nitrosamines.

This fourth annual report presents key data characterising the quality of drugs and FDA-registered drug manufacturers. It is based on data and results obtained by OPQ that provide insights into pharmaceutical manufacturers, their products and compliance with manufacturing standards.

The good news is that sites manufacturing essential medicines (EM), including COVID-19 related mediciens, score well on GMP compliance. They achieve high scores: on average 7.45 out of 10 (for comparison: manufacturers of non-essential medicines achieve an average score of 7.0). "This observation indicates that sites manufacturing EM products have a higher level of adherence to manufacturing compliance standards than sites that do not manufacture EM products", the report says.

But there are also critical figures:

High number of "Import Alerts"

In the past fiscal year 2021, the FDA issued 49 sites an "Import Alert" for refusing inspections, refusing to submit requested documents, non-compliant laboratory tests or non-compliant inspection results. Most sites concerned are located in China and Latin America. Hand sanitiser manufacturers were responsible for all Import Alerts issued for non-compliant laboratory tests.

Growing number of recalls

The number of recalls has increased. Since fiscal year 2019, recalls increased dramatically, from approximately 300 recalls in fiscal year 2019 to more than 700 in fiscal year 2020 and nearly 800 in fiscal year 2021.
It should be noted, however, that the increase in Class I recalls is mainly due to recalls of hand sanitisers containing methanol or, for example, sunscreens contaminated with benzene.

Rate of non-compliant samples increased

CDER samples and tests medicines as part of surveillance and targeted sampling (e. g. hand sanitisers, nitrosamines, opioids and heparin). As many inspections were postponed, this made these tests all the more important.
During 2017-FY2021, a total of 3,861 samples were collected, tested and classified. In fiscal year 2021, the proportion of non-compliant samples was 35%, compared to 16% in the previous year.
The increase is due, among other things, to hand sanitisers and products with nitrosamine contamination, but also blood products and imported products with undeclared ingredients for erectile dysfunction.

Data will be collected in more detail in the future

In addition, the report highlights two initiatives that will enable new approaches to inspection, characterisation and quality improvement: New Inspection Protocol Project (NIPP) and Quality Management Maturity (QMM). These initiatives provide the framework for a future in which inspections and assessments provide data that enable a broader and deeper understanding of site quality. NIPP and QMM will enable the FDA to make better, more informed and faster decisions.
For example, NIPP aims to increase the efficiency of inspections through a more targeted and data-driven approach.

Source: Report on the State of Pharmaceutical Quality: Fiscal Year 2021

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