EM & Risk Management in Modern QC
Latest Trends in Environmental Monitoring. A Q&A with microbiologist Vanessa Vasadi-Figueroa
Environmental monitoring of cleanrooms and isolators has been the focus of a significant rise in regulatory requirements in recent years, as contaminations can spoil pharmaceutical products, slow their time to market and even result in recalls.
A good EM program is a surveillance system that provides a baseline profile of a manufacturing environment, acts as an early warning system to detect possible environmental contaminants that are out of limits and that may impact the product and promptly identifies the sites in the manufacturing environment at risk of contaminating the product. The data gathered in a well-designed and executed EM program provide critical information for tracking and trending on a routine basis.
So what key points could companies consider prior to initiation of an EM program that will help minimize risk and improve understanding of potential sources of contamination in their facility? And how should they approach the assessment of EM data in order to demonstrate a state of control in both US and global regulatory standards.
Vanessa Vasadi-Figueroa, MA, a Partner and Executive Director of Microbiology at Quality Executive Partners, addressed these questions during a recent webinar, Best Practices for Environmental Monitoring and Risk Management, hosted by Charles River. Eureka, Charles River's science blog, caught up with Vanessa last week to talk about some of the big trends in EM. Here are her edited responses
You work closely with PDA and keep up with the latest regulatory guidance. What regulatory trends do you anticipate surrounding environmental monitoring?
VF: Over the course of my career, I’ve seen a shift in the way the industry approaches environmental monitoring, and it makes me excited. It used to be that inspectors arrived at a facility and asked for recent EM trends and investigation reports. Now regulators want to see that companies demonstrate a forward-thinking EM strategy. The proposed revision of EU Annex 1 contains a section titled Viable and non-viable environmental and process monitoring, and includes additional guidance on the qualification of cleanrooms. It is always wonderful to see our international regulators clarify their expectations. To me this means more companies will get on board and provide data to inspectors that actually supports a forward-thinking approach. Understanding that cleanrooms should be requalified periodically using risk management techniques will go a long way toward helping us ensure better contamination control.
You work with clients across globe and in various industries. From your experience, what do you think is the most critical part of an EM program?
VF: Undoubtedly, understanding and interpreting the large volumes of data captured by an environmental monitoring program. I try to encourage my clients to understand the power behind this data because it is trying to tell us a story. That story may be a good one, or a complicated one, but in either case we have an obligation to collect, analyze, and interpret this data in a meaningful way. Trending is a very critical tool for evaluating how the facility is performing and affords us the opportunity to manage circumstances when the facility deviates from normal operating parameters. I also encourage my clients to analyze the data in real time. This ensures that we listen to the story, and rewrite it by improving manufacturing conditions.
What advice would you give to a current QC lab manager?
VF: Be open-minded. We are in exciting times with rapidly increasing technologies for both new products in the manufacturing area as well as new testing equipment and methods in the laboratory. Adapting to these new technologies requires us to change the way we think about our approach towards controlling quality. More importantly, we need to be thinking about how we can build quality into the process and product. Even though rapid microbiological methods (RMM) have been around for quite a long time, I see far too many companies, and specifically the QC Microbiology departments, not taking full advantage. Therefore, I would encourage managers to explore how they can implement stronger, more efficient methods and possibly acquire new equipment, thus allowing them to detect potential contamination closer to real time. Managers should also encourage their microbiologists to propose new methods or technology so they own part of the decision and implementation process.
Any hot topics you feel have lost their buzz or don’t get discussed frequently?
VF: Just like every other industry, pharma uses certain words often and then buzz is created around the globe. Some of the words stick, and some of them do not. My favorite hot topic has always been data integrity because in a global and digital world, this means the application of data integrity can be different for each company. For QC Microbiology, data integrity is even more important because there is so much variation in the way we document our results. Some results go into electronic data capture systems such as a laboratory information management system (LIMS), while others still get documented using manual forms on the benchtop. I believe the future is all electronic, but this transition phase can be somewhat challenging for analysts and having a good documentation procedure in place ensures the most success. Accuracy is key too; ensuring that our results are interpreted properly requires thoughtfulness because we have so many different methods in QC Microbiology. The regulatory expectations for data integrity haven’t changed in decades, but our understanding and application of data integrity principles must evolve to the current way in which modern laboratories function.