EMA - Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products

18th April 2024

EMA

Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products. Reference Number: EMA/CVMP/196216/2021.

This document provides guidance on good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) used in veterinary medicinal products. It provides an appropriate system for managing quality and, as such, is intended to help ensure that APIs meet quality and purity standards. It applies to APIs manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these.

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