FDA Announces Draft Guidance on GMPs for Pharmaceutical Ingredients in Veterinary Drug Products

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The U.S. Food and Drug Administration has announced the availability of a draft guidance for industry (GFI) #286 (VICH GL60) entitled, “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

VICH is a trilateral program officially launched in April 1996. The program aims to harmonize technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. In support of wider international harmonization of regulatory requirements, VICH guidelines are also available for use by other countries.

This draft guideline has been developed based on a similar guideline (ICH Q7: Good Manufacturing Practices for Active Pharmaceutical Ingredients) intended to cover human drugs from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The objective of this draft guidance is to provide recommendations regarding good manufacturing practices (GMPs) for the manufacturing of active pharmaceutical ingredients (APIs) for use in veterinary medicinal products. It facilitates harmonization of a single set of international standards for GMP inspections of facilities that manufacture APIs and starting materials for use in such products. It also allows manufacturers and regulators a framework to ensure that APIs meet the quality and purity characteristics that they are intended to possess.

The FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. The FDA’s work with VICH aims to ensure regulatory certainty for veterinary products, including predictable and uniform requirements across the E.U., Japan and the U.S. The collective work also helps to reduce animal testing, facilitate trade, and ensure veterinary product safety and consumer confidence in the regulated products.

Although the public may submit comments on any FDA guidance document at any time, the agency is encouraging the public to submit comment(s) on the draft guidance within 60 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance document. The public may be submit comments electronically and type the following docket number into the search box: FDA-2023-D-4761.

The public may also submit comments by mail using the address below:

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.