Are You Ready For The Coming Wave Of Regulatory Compliance?

The COVID-19 pandemic has exposed significant vulnerabilities in the global supply chains for medical products, underscoring the importance of maintaining their integrity to ensure patient access to critical treatments. It also sparked a rapid acceleration in the development, testing, and production of COVID-19 tests, treatments, and vaccines. Alongside this unprecedented pace came extraordinary flexibility from regulatory authorities. While necessary to meet urgent needs, these adjustments present potential challenges for medical product manufacturing and testing facilities. Here are five key developments observed during this period.

First, many manufacturing companies implemented measures to reduce viral spread by allowing employees, including those responsible for quality oversight, to work off-site. Although these risk-based decisions were pragmatic, they may have created gaps in monitoring and quality control that could only be fully identified when on-site operations resume.

Second, the pandemic severely restricted regulatory authorities’ ability to conduct on-site inspections. For example, the U.S. Food and Drug Administration (FDA) reported a 56% decrease in domestic and foreign inspections in 2020 compared to prior years. While the FDA has resumed or is preparing to restart inspections in some regions like China and India, there is a significant backlog that may take time to clear. The agency will likely prioritize facilities using risk-based indicators as it works through these delays.

Third, to address the lack of on-site inspections, regulatory bodies adopted virtual tools for facility assessment. The FDA, for instance, utilized its authority under the Food, Drug, and Cosmetic Act to request records in place of inspections. Although virtual reviews provide insight into a facility’s compliance, they are generally not as thorough as on-site inspections. However, virtual assessments have proven useful, with many reviews yielding positive outcomes, and some even leading to approval decisions for drug applications.

Fourth, the FDA has broadened its use of Emergency Use Authorizations (EUAs) during the pandemic to expedite the production of COVID-19-related products. This has allowed manufacturers to bypass certain regulations, including Good Manufacturing Practice (GMP) waivers due to limited inspections. Despite the temporary relief, facilities granted EUA approval may face future inspections as pandemic conditions stabilize, potentially revealing compliance issues.

Lastly, the FDA is working on tools to monitor the quality management maturity (QMM) of facilities more closely. This system will help regulators decide whether to rely on virtual assessments or conduct on-site inspections, using data from multiple sources. A high QMM rating could become a key factor in regulatory decisions and provide biopharmaceutical companies or consumers with valuable insights into the quality of a facility.

In light of these developments, maintaining proactive compliance is crucial for manufacturing facilities. Those that demonstrate strong quality management and compliance during virtual or on-site inspections will likely fare better in the future. For companies struggling with compliance, investing in remediation efforts may be necessary to avoid negative regulatory consequences. Ultimately, maintaining high standards can strengthen the entire supply chain, ensuring critical medical products reach patients in need.