What’s black and white, read all over, with lots of gray areas in the middle? That would be Stability regulations, guidances, the best of practices and the rest of practices. The gray areas are the stability program situations that arise every day that aren’t governed by anything other than those “rest of practices”, which are nothing more than our best judgement in no-win situations. StabilityHub’s latest Situation Room scenario paints just such a pickle. A calendar puts days where people aren’t available, a pandemic makes a room full of chambers into a ghost town, and data has gaps and asterisks. What do Stabilitarians do with these predicaments? The default option is to hope these situations won’t draw notice during inspections and audits, but we can do so much better with the tools available to us. Let’s explore a few of these.
Quality Investigations and CAPAs
These can provide a thorough analysis of the original situation, fuel improvements that will prevent recurrence and diminish the delight of authorities who unearth an observable deviation. We may be reluctant to air our dirty laundry to the scrutiny of our quality peers, but this option will help us develop the best path forward and reduce the number of stress-inducing scenarios that come our way.
Presentations that present the challenge and your chosen solution in the best possible light. Away from auditors raising question after question, our team has time to imagine the questions and all their nuances in advance, formulate rational responses with sound justifications and present them in orderly fashion. A decades-old piece of advice from a Senior Manager was “take the club out of their hand” by addressing a messy issue before it comes up.
Providing an acceptable reason for your chosen course of action. What constitutes “acceptable?” At minimum, we can choose from 4 levels with varying degrees of appeal, the best being scientific rationale. Providing data to justify your point tends to turn aside a great deal of skepticism. Citing the fulfillment of regulations and guidances is also a solid justification, just ahead of industry best practices, which are more difficult to round up, though not impossible. Presentations, publications, and forums can be helpful in this regard. Live polls have an impact as well. There was one instance during an FDA inspection when a company was challenged regarding an industry best practice claim, and they succeeded within hours in obtaining a significant response from industry stabilitarians to a poll on the question. The least reliable justification is that “we’ve always done that way and we’ve never had a problem.” If you find your self resorting to this defense, at least dress it up with some numbers and positively phrased results, such as “Our procedure has yielded positive results for 5 years and has yet to be challenged.”
Creative Solutions Becoming Best Practices
It’s very worthwhile to actively monitor industry news, seminars, publications, forums, and websites to see what could be emerging as best practices. Not every new trend is appropriate for your application, but you may discover your alter-ego dealing with a challenge similar to yours. In many cases, direct conversations can be had to discuss details and achieve a still more effective outcome.
We find ourselves in a gray area more often than we’d expect. If you’ve just muddled through a gray situation, it won’t be long before the next one arises. Use all the tools you have at hand to get to the best outcome. Find your way through the gray; you are not alone, either in-house or across our industry.