Rebuilding Trust
One consistent roadblock I encounter with assisting in the development and rollout of data/process governance systems, regardless of the geographical region, is the possibility for receiving a regulatory citation (e.g., FDA Form 483) if the investigator disagrees with the implemented “risk-based approach”… This concern is warranted to some degree, based on serious disharmony both across and within regulatory agencies, and statements made by inspectors during site visits. We have a number of regulators roaming around writing (in my opinion) unfair citations, as they do not fully grasp the concept of risk acceptance, and therefore default to the expectation that risk always be lowered wherever feasible, regardless of criticality/context. This is unwise, as this expectation results in a breakdown of the quality system as it collapses under its own weight – patient harm is the result.
We see a number of these unfair citations lately in the world of aseptic filling via isolator technology, which has created great fear in our industry and hesitation to accept any risk across the product lifecycle. Industry shares half the blame, however, as the tools being used to defend a risk-based approach are more often than not inappropriate. In this blog you have heard me write countless times regarding the tragedy of FMEA in GMP, which has caused the regulator to lose confidence in our ability to objectively assess and control risk. This misalignment, with both sides sharing blame, has set our industry back years, preventing implementation of advanced quality systems described in ICH Q10.
So what’s the answer? Adjust your 1) tools, and 2), mindset; and move forward. Understand that regulatory citations are inevitable, but regulatory action (OAI) is highly, highly unlikely to the point of an impossibility. Any expectation of “zero 483s” is an unrealistic goal, and why would any leader set unrealistic goals for employees? Not cool. Regulators will take some time to adjust to the paradigm shift currently underway, as we shift from reactive to proactive quality/business strategies. It will also take time to rebuild trust in our ability to objectively assess and control risk. In the meantime, do not let the fear of an individual unwarranted citation prevent you from achieving your mission as a company.
It pains me to write this post, but regulatory harmonization (even within an individual agency) in the world of a QRM future has proven more difficult than I had anticipated. Spend as much time as you can studying the principles of risk, and be ready to vigorously defend your objective QRM approach during inspection. Stagnation is your only other option; so check out the new draft EU GMP Chapter 4 and get started, have fun with it and realize your full potential as a critical thinker and business leader!
