Is my ICH the same as your ICH?

Our US east-coast-based stability program just got audited by an internal inspector from our European headquarters. We typically have several FDA inspectors come through our stability area each year but have never received any comments, much less a 483. Still, this inspector who manages a large European stability group was very concerned about our compliance with ICH, insisting that we are in danger of receiving even a warning letter if we don’t remedy some of their observations.

We believe that their ICH interpretation is biased by risk intolerance but are stumped as to how we can respond without bringing European QA management down on us. Some examples of things they were concerned about are: 1) Our procedures do not specifically reference ICH Q1 documents from which the various requirements were derived. 2) We use Zone IVb conditions to satisfy less stringent zone requirements (thus avoiding multiple studies). 3) We don’t pull duplicate samples and keep one aside in case the lab needs more for testing. These are just three among several others.

How are ICH requirements viewed differently and implemented differently in different parts of the world, and is it necessary for a company to implement the strictest practice worldwide?

It sounds like you do need to harmonize your global stability programs, especially since the boss is the boss, but not just for that reason. It is important for a global company to implement ICH requirements consistently. The few differences you described are perfect examples of highly visible practices (high risk of detection) that should be globalized, while some other minor practices can be built into lesser more localized procedures.