Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.
During the pandemic, most regulatory authorities restricted their inspections of pharmaceutical manufacturing facilities. Now that inspections have started up again, sites may find themselves more vulnerable due to undetected issues that have built up in the lengthy gap between inspections. This can be a particular problem when it comes to manufacturing sites that are in a different jurisdiction from corporate headquarters as, during the pandemic, these sites may have experienced reduced oversight, coupled with the loss of experienced staff and other resources.
Regulatory agencies have acknowledged that delays in inspections caused by the pandemic have created backlogs with regard to the approval of regulatory submissions. As a consequence, life sciences companies may also face the challenges of inspections at sites that are part of pending applications.
As regulators work through the backlog, we are still seeing a number of sites that are overdue for a regulatory inspection. During this time, there is still an opportunity for these sites to prepare for their next inspection. Preparation typically involves thoroughly examining the site’s quality systems. A strong quality system serves as the core building block of good manufacturing practice (GMP) by establishing processes and procedures that guard against human error by detecting and addressing issues early — before product release. Preparation can also mean grappling with the web of regulatory challenges facing life sciences companies when it comes to maintaining resilient systems for the manufacturing of safe, quality products.
Preparing for an upcoming regulatory inspection can provide a chance to review the site’s ability to meet supply obligations and to deliver new products to market. Many life sciences companies are currently looking to invest in more reliable sourcing options, with a focus on having less-extended supply chains. This may mean that they are investing in retooling existing manufacturing facilities or in building new state-of-the-art facilities. It could also mean updating manufacturing processes through the application of new technology, such as moving toward a continuous manufacturing model. All of these updates provide an excellent and timely opportunity to implement and validate new processes.
Regulatory changes may also provide life sciences companies with opportunities to engage proactively with regulators in advance of inspections, including emphasizing the investments made to address and update GMP issues and processes. It may be advisable for companies to encourage regulatory agencies to use the newer inspection techniques employed during the pandemic, and to collaborate on this approach. We will explore these techniques in a future blog post.
Generally, as regulatory agencies move to take a number of non-COVID-related issues off the back burner, sites should prepare for a renewed focus on inspections.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.