Concerning the distinction that you made between ICH versus VICH for APIs for veterinary products, which standards do the FDA inspectors use in the plants producing APIs for US vet products? Are there any differences seen during a PAI, and which standards should a plant follow?

Since the VICH at this point has not adopted Q7A, FDA investigators may use Q7A in inspecting
manufacturers of APIs for veterinary drug use. Any issues or deficiency findings will be brought to
the attention of their office of compliance, the Center for Veterinary Medicine. They will then apply
what is commonly referred to as regulatory discretion with respect to those APIs for vet use. To
summarize, since we lack GMP guidance specifically for APIs for vet use, the best guidance
investigators could use is Q7A.