We’ve heard Europe has defined a fourth level of water purity called highly purified water, which seems to be aimed toward the production of APIs. What impact will this have on the other ICH regions and Q7A if any?

Q7A, like any GMP document, does not define standards. API manufacturers should establish
adequate specifications for process water, but Q7A does not define or specify the use of purified
water, highly purified water, or WFI. This is outside the scope of Q7A.