EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products

After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and planned mitigation is prudent, if not a virtue, but to over anticipate and have no ‘plan B’ can be inspection suicide. Factor in the endless myths and legends that prevail as folklore in the industry, particularly for the FDA, and it is frankly not surprising that I have seen so many ‘rabbits in the headlights’ during inspections – sadly, often more through being caught off guard, than through lack of subject matter expertise. In my own considerable, yet still by no means infinite, experience, the area where inconsistency is most consistent a factor, is human tissue-based products’ regulatory inspections – but more in the context of the inspections of the regulations, rather than the regulations themselves.