A contrarian’s approach for enhancing GXP compliance


Almost every day, a new approach for enhancing GXP compliance is proposed, espoused, or encouraged. Yet, our industry continues to experience problems with non-compliance. Some of these result only in adverse publicity for the recipient, though some result in potentially serious safety issues for consumers.

Is there anything truly new that can help us assess potential GXP concerns and, thus, drive compliance enhancement? Perhaps not. Nonetheless, I would like to pose a new way of looking at compliance that can possibly stimulate a new way of looking at these issues. I call this the contrarian’s approach to enhancing GXP compliance. You may have heard of contrarian investors… individuals that invest in companies experience bad news. A contrarian is someone that opposes or rejects popular opinion. In the world of compliance, a contrarian is not apt to automatically believe all the good audit reports they receive or the good inspection history of the site. The contrarian’s approach to compliance involves looking for bad news, not merely looking for what is going well. The contrarian asks the truly hard questions of compliance.

Let’s look at a few questions that can stimulate the contrarian’s approach. Ask these example questions of your team to generate alternative viewpoints of your own current compliance position.

  1. If we have a recall next week, what will be the issue that caused it? Could we prevent it today, if we knew it?
  2. If two individuals in your lab wanted to dry lab results, how could they do it given your current systems and protection of data? What would we have to do to prevent it?
  3. What will be the primary concern noted on the next Warning Letter your firm receives? Do we have to accept that this will happen or change we change the future if we act today?
  4. If your only job was preventing the next batch failure, what actions would you take today? What would you do if your job was literally in the balance?
  5. If an angry employee wanted to sabotage a batch of product by mislabeling a few units, how would they do it? Is it possible that one angry individual could destroy your reputation as a company?
  6. If someone wanted to hide your next stability (or sterility or environmental) failure, how would they do it? What systems have to be defeated for an individual to hide an undesired result?
  7. If an operator needed to make unauthorized and undetected changes to a manufacturing process, how would they do it? Can you devise systems to prevent it?

These are only example questions. You could develop your own depending upon your operations. However, the concept is simple… if you wanted to foil your systems, could you do it and, if so, how? Or, if something bad was going to happen, what would it be and could you prevent it now, if you knew it?

GXP compliance is much more than following a checklist. It involves thinking beyond the regulations and seeking deeper, more complex answers. When you actually believe all the good audit reports you get each month, you are failing to recognize the underlying potential for disaster that could await. Think about using the contrarian’s approach to identifying possibilities that until today have not been adequately considered.

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