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GUIDANCE DOCUMENT

CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products January 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-4761
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This document provides guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.  It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4761.

Questions?

Contact Point
Mai Huynh
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Mai.Huynh@fda.hhs.gov
240-402-0669
 
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