I attended a session this morning at Interphex 2008 and the speaker pointed out that there are clear doubts among industry about harmonization. Will all three regions–the US, Europe, and Japan–really be able to pull off this massive effort? Industry doubts about harmonization have been around since, well, the idea of harmonization was introduced, but what is interesting to consider, is, does it matter? If FDA is fully behind harmonization and QbD, specifically ICH Q 8, Q9, and Q10, it may not matter whether or not Europe and Japan are also on board.
One case in point, I recently toured a manufacturing facility overseas that’s about half-way built. They have had a few inspections already and are gearing up for more before they become fully operational. I asked the manager which inspection he was most fearing–FDA’s, the UK’s, or any of the other national inspectors that may be stopping by to take a look around. He answered, “Well, FDA’s inspection is really the only one that matters.” And this was coming from a UK company at a UK plant.
If this is the feeling among plant managers worldwide, how important is harmonization? Now I’m not trying to downplay the importance of harmonization–in fact, I fully support it. In this global industry, global collaboration is a must. But playing devil’s advocate for a minute here, what if everyone just followed FDA’s rules and took its approvals or nonapprovals as final word?