VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products - Scientific guideline

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.

Keywords: manufacturing, good manufacturing practice (GMP), active pharmaceutical ingredient (API), quality system, VICH, veterinary medicinal product.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

Current version

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

Consultation dates: 06/10/2023 to 25/03/2024Draft: consultation openReference Number: EMA/CVMP/196216/2021Summary:

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.

Keywords: manufacturing, good manufacturing practice (GMP), active pharmaceutical ingredient (API), quality system, VICH, veterinary medicinal product.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]