International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability

The Animal Health Institute (AHI) would like to thank FDA for their continued leadership in VICH. AHI supports the proposed guideline. The guideline will harmonize expectations during GMP inspections of facilities that manufacture APIs. Additionally, it allows manufacturers and regulators a framework to ensure that APIs meet the quality and purity characteristics they intend to possess. AHI received two comments from the animal health community. We are respectfully submitting them for consideration.