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

Issue Date: January 25, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Postmarket, Premarket, Compliance, Current Good Manufacturing Practice (CGMP), Chemistry, Manufacturing, and Controls (CMC), Generic Animal Drugs, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), VICH
Status: Draft

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

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.

Download the Guidance Document

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