By Nicholas Markel, NSF Pharma Biotech
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry the past few years. While most of us might think we understand intuitively what the words mean, perhaps we don’t. To that end, let’s dispel a myth right away. The term aging facility may conjure up an image of a facility that is akin to a haunted house from a bad movie, complete with a peeling epoxy floor, pocked and pitted walls, rusting equipment, cobwebs in the upper reaches of the warehouse, strange creaks and groans when you pull water, and sallow, graying, and indifferent staff. This is not necessarily the case, and I freely admit that aging facility may not be the best term. I hear and see people reacting strongly against the aging terminology and in fact using different terms (i.e., ignored, antiquated, neglected, maturing, and outdated). A good case could be made for any of these terms, plus others that I am sure you can think of. However, rather than spending energy trying to create a new term and, given that the term aging is “out there” and being used, I will stick with it and instead use this article to try to give a little more context around the issue.
What Is An Aging Facility?
I have yet to see, or be successful coming up with, a single succinct and simple definition for aging facility. It is far easier to use descriptors and examples. Therefore, it might be useful to propose a general definition of an aging facility and move on from there. A simple (and maybe oversimplified) definition could be: “A facility that is no longer functioning at the capability needed to meet capacity at the required quality.”
Age Is Just A Number
Just because your facility is getting on in years doesn’t necessarily mean that it’s aging and, furthermore, to date, no regulatory inspection report that I am aware of has cited aging facility as an issue. I have worked in several old facilities (including some built in the 1970s) that are just gorgeous, operate at full capacity with minimal downtime (unexpected or otherwise), and can in no way, shape, or form be considered aging. Conversely, I have been in facilities built in the early 2000s that clearly could be considered aging. What’s the difference? First, let’s talk about how to diagnose an aging facility and then I’ll close with some thoughts on what causes a facility to be considered aging if not simply the passing of years.
Diagnosing An Aging Facility
Given that chronology is not the best predictor of aging, a diagnosis is best determined by indirect indicators. Ask yourself some of these questions. If the answers are overwhelmingly YES, then you may have an aging facility that needs to be addressed.
My Facility Is Aging; Now What?
There is not an easy answer to this question and there are many factors to consider. Potential solutions can run the gamut from hiring “MacGyver” and supplying him with bubble gum and paper clips, exercising creativity with procedures in order to address engineering deficiencies to investing in new equipment or even building a new facility. Each approach has its pros and cons, and in reality there is a time and a place for each of them -- except for the use of bubble gum, of course!
Therefore, the decision on which direction to take is complicated. The decision must consider factors such as process robustness, quality, cost, regulatory hurdles, and ongoing compliance. These factors inherently create a dynamic tension between maintaining the status quo vs. improvement and innovation, as well as the very real question of cost to the bottom line. Is it worth investing in new equipment to modernize the process? Many of us have older facilities running older (well established) processes, and we find ourselves compensating with creative solutions rather than taking the leap and adopting new technology or innovating. Why are we reluctant to innovate and/or adopt new and better technology? Shouldn’t innovation be encouraged and supported? Some of the uncertainty seems to be related to the perceived lack of clarity regarding expectations from regulatory authorities as well as pressure from management or shareholders to keep costs down.
Credit should be given to the regulatory authorities, as progress is being made, as evidenced by small changes such as the decision that water for injection made via distillation or vapor compression is now considered acceptable by both U.S. and EU regulators. Even more exciting is the concept of the pre-operational visit (POV) via the Emerging Technologies Team at FDA.
And of course, it is just good business to consider the impact to the bottom line. That said, we should all strive to balance the “holy trinity” of budget, quality, and schedule and hopefully not find ourselves living this adage shared with me by a former mentor: “There are always three factors to consider: budget, quality, and schedule -- pick two.”
Why Is My Facility Considered Aging?
If not due simply to the passing of time, what other factors are related to my facility being considered aging? In a few words: vision, commitment, and management. There are several factors that can contribute to this issue and it is important to realize that your facility didn’t become aging overnight. Allow me to use a metaphor to describe what I mean. Using myself as an example, I used to be athletic, fit, healthy, and active. Fast forward 20 years and I have put on weight, no longer participate in athletics, have health issues, and have become much more sedentary. Clearly there are reasons behind this particular evolution, as not everyone turning 50, as I recently did, has gained weight or needs to spend Sunday recuperating from a day of yard work they did on Saturday! Many 50-year-olds are active and healthy and can run circles around those who are younger. Why is this? People who age gracefully have:
It is quite easy to extend this metaphor to aging facilities once you recognize and accept that facilities (just like us) need more care and feeding as they age than they did when they were young.
If, after considering the questions above, you feel you do indeed have an aging facility and are perhaps suffering from a bit of paralysis by analysis, consider developing a plan to include both immediate (e.g. document rationale and risk assessment for atypical layouts) and long-term fixes (e.g. strategic planning and discussions with regulators).
About The Author:
Nicholas Markel has 25 years of experience in the biopharmaceutical field and 15 years of experience providing general and strategic consultation to domestic and foreign clients in the biotech, biologic, and pharmaceutical industries, assisting with manufacturing issues and development of quality systems and regulatory strategies. Markel’s areas of expertise include techniques used in biopharmaceutical production for human use, review and development of quality systems, conducting cGMP compliance audits, deviation investigation, CAPA generation and implementation, oversight of manufacturing contractors and manufacturing activities, overall project management, commissioning of new and revised facilities, process validation, man-in-the-plant services to oversee operations, and compliance.