In response to several high-profile industry incidents that have had significant implications for consumer safety, the FDA is investing greater time and resources in its review and oversight of the pharma industry as a whole. The evidence thus far points to the agency taking a more active role in smart and systemic regulation to avoid product safety issues.
One of the ways we can expect the FDA to tighten its oversight of the industry is to increase the frequency of unannounced audits at pharma companies, to make certain that manufacturers’ operations are in compliance with all associated regulatory requirements. Although the unforeseen audit is nothing new to many in the industry, the anticipated uptick in these audits will likely catch many companies off guard, as the agency seeks out new and more efficient ways (e.g., remotely) to perform them.
To properly prepare for these changes, it is now more important than ever that companies proactively implement an effective quality management system to ensure compliance across the enterprise. Using an enterprise-wide approach to quality management will help companies store, manage and centralize data, while reacting to this data in real-time to ensure the health of the quality system. Ultimately this will make it easier to comply when the FDA does perform an unannounced audit, while companies that fail to take this approach run the risk of accruing hefty fines or, more severely, being ordered to halt production of new products altogether.
Implementing an enterprise-wide quality and compliance system can have additional benefits beyond simply preparing companies for an audit. And while deploying such a system can at first seem like an overwhelming and daunting task, the benefits far outweigh the tasks associated. Such an implementation can help pharma companies streamline quality processes, consolidate redundant systems and reduce manual operations.
Signs now point to the pharma industry experiencing significantly greater scrutiny from the FDA in the coming months, but the increased frequency of unannounced audits does not have to stop a company in its tracks. Companies can prepare for the impending uptick in audits by proactively leveraging a quality and compliance management system for centralization and reconciliation of required audit data. Implementing such a system will not only help to ensure compliance with unforeseen audits – it will also maintain and protect brand integrity by helping to minimize risk, streamline quality processes and reduce safety issues, ultimately resulting in the production of higher quality products.
Tim Mohn is an industry principal in Sparta Systems’ product management group, helping implement enterprise quality management software, TrackWise. Check him out at Tim.Mohn@spartasystems.com
