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Guidance Issuing OfficeCenter for Veterinary Medicine
This document provides guidance to registration applicants on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new veterinary drug substances not previously registered in a country, region, or member state. Alternative approaches may be used if such approaches satisfy the requirements of applicable statutes and regulations.
This guidance is complementary to the VICH GL10(R) guidance “Impurities in New Veterinary Drug Substances,” which should be consulted for basic principles. The VICH GL18 guidance, “Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients” should also be consulted, if appropriate.
This guidance addresses only those impurities in new veterinary medicinal products classified as degradation products of the new veterinary drug substance or reaction products of the new veterinary drug substance with an excipient and/or immediate container closure system (collectively referred to as “degradation products” in this guidance). Generally, impurities present in the new veterinary drug substance need not be monitored or specified in the new veterinary medicinal product unless they are also degradation products (see guidance VICH GL39 on specifications).
Impurities arising from excipients present in the new veterinary medicinal product or extracted or leached from the container closure system are not addressed in this guidance. This guidance also does not address new veterinary medicinal products used during the clinical research stages of development. The following types of products are not addressed in this guidance: biological/biotechnological products, peptides, oligonucleotides, radiopharmaceuticals, fermentation products and semi-synthetic products derived therefrom, herbal products, and crude products of animal or plant origin. Also excluded from this document are: (1) extraneous contaminants that should not occur in new veterinary medicinal products and are more appropriately addressed as good manufacturing practice (GMP) issues, (2) polymorphic forms, and (3) enantiomeric impurities.
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:
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-1999-D-0048.