The U.S. Food and Drug Administration (FDA) has released the updated Guidance for Industry #100, titled “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances, and Excipients (Revision 2), VICH GL18(R2).” This revision provides comprehensive recommendations for controlling residual solvents in veterinary medicinal products, ensuring animal safety and product quality.
Understanding Residual Solvents in Veterinary Medicines
Residual solvents are organic volatile chemicals used or produced during the manufacturing of active substances or excipients, or in the preparation of veterinary medicinal products. While they are not intended to be present in the final products, residual amounts can remain, potentially affecting the safety and efficacy of the medicines administered to animals.
Scope and Objectives of the Guidance
This guidance applies to new veterinary medicinal products, active substances, and excipients, focusing on the acceptable levels of residual solvents to ensure product safety. It aligns with the principles established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), promoting consistency across different regions.
Classification of Residual Solvents
The guidance classifies residual solvents into four categories based on their risk assessment:
- Class 1 Solvents (Solvents to be Avoided): These are solvents known to be carcinogenic, genotoxic, or environmentally hazardous. Their use in veterinary medicinal products is strongly discouraged due to their unacceptable toxicity.
- Class 2 Solvents (Solvents to be Limited): Solvents in this category are non-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity, such as neurotoxicity or teratogenicity. Their levels should be limited to protect animal health.
- Class 3 Solvents (Solvents with Low Toxic Potential): These solvents have low toxic potential to animals, and their presence is generally considered acceptable without a specific limit when used at permitted levels.
- Solvents Without Adequate Toxicological Data: For solvents lacking sufficient data, a comprehensive risk assessment is necessary to determine their acceptability and appropriate limits.
Recommendations for Manufacturers
Manufacturers are advised to implement appropriate controls to limit residual solvents in their products. This includes selecting suitable solvents during production, employing effective purification processes, and conducting rigorous testing to ensure compliance with the specified limits. Adhering to these recommendations helps maintain the safety, efficacy, and quality of veterinary medicinal products.
Conclusion
The FDA’s updated guidance on residual solvents underscores the commitment to animal health and safety in veterinary medicine. By classifying solvents based on their risk profiles and providing clear recommendations for their control, the guidance assists manufacturers in producing high-quality veterinary medicinal products. Compliance with these standards ensures that animals receive safe and effective treatments, reflecting the ongoing dedication to excellence in veterinary pharmaceutical practices.
CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
By Shudarsana Company
