Generally, guidance is enforced by linkage to the country’s laws. Also, you’re going to make it
enforceable by your purchasing power. FDA can do for cause inspections just about anywhere in
the food, drug and cosmetic chain. In light of counterfeiting issues that are going on around the
world, the bottom line is the real enforcement issue here is going to happen when the users of
these materials are going to demand compliance with Q7A.