FDA announces GMP guideline for Veterinary APIs

The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products (CVM GFI #286 (VICH GL60)) is issued by Centre for Veterinary Medicine (CVM). This guideline is developed based on ICH Q7: Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) for human APIs. The requirements for Quality and Purity elaborated in the draft guideline is similar to ICH Q7A. The requirements for various Quality system elements like Personal Hygiene, Hygiene and Sanitation, Water, Building and Facilities, Containment, Equipment Cleaning and Maintenance, Stability, Recovered Solvents and other Quality system elements are same as ICH Q7A. Under Section 4 Containment the guidance calls for adequate quality controls and use of Quality Risk Assessment (QRM) for determining the extent to which areas can be shared and mitigate associated risk of cross contamination

Guidance Document