The GMP expectations for an exhibit batch for an ANDA submission are likely to be the same those of the commercially manufactured API. By the time you are filing the NDA, you would have a better idea of what your critical process parameters were, for example, than you would in the early phases of development. Again, think of that increasing scale, and by the time are ready to start putting your NDA together, you’re starting Phase III, and so you should have more data than early on.
