FDA Office of Pharmaceutical Quality publishes Annual Report 2021

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7/8 May 2024

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The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?

In the beginning the report describes the "mission" of the Office of Pharmaceutical Quality (OPQ). The OPQ's mission is to ensure that quality medicines are available to the American population. Access to quality medicines was also the focus of the White House 100 Day Report. The White House report recommended strategies for supply chain transparency and resilience. Among other things, however, the White House report also recommended introducing an evaluation system to assess the robustness of quality management systems in pharmaceutical production facilities. The OPQ is currently working on this. The goal is to show the companies that quality management systems do not only include simple compliance with GMP rules, but go beyond that. Currently, a pilot programme is still underway with foreign companies to assess their Quality Management Maturity (QMM) ratings.

However, inspections, among other things, are seen as the core competence of the QPQ. Pre-Approval inspections (PAI) are needed to show that a manufacturing site named in an approval can also produce in accordance with GMP. The PAI also includes the verification that the data in the marketing authorisation application are correct and complete. The PAI covers 20% of the time to ensure this.

Despite the Covid-19 pandemic, the OPQ conducted 47 PAIs in 16 different countries in 2021. However, also 52% fewer on-site inspections were conducted, due to the use of alternative procedures. Alternative procedures will continue to be used in the future - but inspections remain an irreplaceable standard, the report says.

The OPQ's market surveillance in 2021 focused on hand sanitizers and nitrosamines. In the regulatory area, one of the OPQ's main tasks in 2021 was the publication of the ICH Q12 guideline and its implementation in the USA. In addition to the above activities, meetings with FDA experts are also offered through CDER to discuss new manufacturing technologies with industry prior to approval. 

Please see the FDA website for the full OPQ Annual Report for 2021.