FDA drafts guidance on veterinary drug ingredients manufacturing
GFI #286 VICH GL60 is now seeking public comments
The FDA recently announced that a draft guidance for industry (GFI) #286 (VICH GL0) titled “Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products” is now available. The draft was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
According to the release, VICH is a trilateral program that launched in April 1996 and aims to harmonize technical requirements for approval of veterinary medical products within the European Union, Japan, and the United States with input from both regulatory and industry representatives included.1 GFI #286 VICH aims to create the opportunity for international compatibility of regulatory requirements, and they will be available for other countries to use.
Like ICH Q7: Good Manufacturing Practices for Active Pharmaceutical Ingredients, which is intended to cover human drugs from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), GF1 #286 guides recommendations regarding good manufacturing practices (GMPs) for manufacturing active pharmaceutical ingredients (APIs) for veterinary medicinal products.1
It facilitates the harmonization of a single set of international standards for GMP inspections of facility manufacturing APIs and starting materials to be used in these products. GFI #286 VICH GL60 will also allow manufacturers and regulators a framework to ensure that the APIs meet the quality and purity characteristics that it is intended to possess.1
The FDA has previously participated in efforts to increase harmonization internationally and committed to seeking scientifically based technical procedures for pharmaceutical development.1 The FDA’s goal of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies across the globe.
Through its work with VICH, the FDA aims to help guarantee regulatory certainty for veterinary products such as predictable and uniform requirements across the European Union, Japan, and the US. The collective efforts also help reduce animal testing, facilitate trade, and ensure product safety and consumer confidence with regulated products.
The FDA is encouraging the public to submit any comments on the draft guidance within 60 days to make sure the FDA considers comments before starting the final version of the guidance document, but the FDA also wants the public to know it will accept comments at any time.1 Comments can be submitted electronically on https://www.regulations.gov and use docket number FDA-2023-D-4761 in the search bar. Comments may also be submitted via mailing them to this address:
Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.
Reference
FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products. News release. January 24, 2024. Accessed January 25, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-draft-guidance-good-manufacturing-practice-active-pharmaceutical-ingredients-used?utm_medium=email&utm_source=govdelivery
