Veterinary Disinfectant Test Report Templates published by China’s IVDC

Veterinary disinfectant test report templates were published on June 24, 2024, by China’s Institute of Veterinary Drug Control (IVDC). The 16 newly introduced veterinary disinfectant test report templates represent a significant regulatory change to enhance the quality of veterinary disinfectant registration in China, providing manufacturers with standardized guidelines for testing and reporting. These templates are designed to ensure thorough evaluation and documentation of disinfectants’ efficacy and safety, aligning with Chinese regulatory requirements. 

Overview of the New Test Report Templates 

The 16 new templates cover a wide range of tests, each focusing on different aspects of disinfectant performance and impact. Here is a comprehensive list of the templates issued: 

1. Quantitative Killing Effect on Bacterial (Propagules/Spore) Suspension 
2. Quantitative Killing Effect on Bacterial (Propagules/Spore) Carriers 
3. Qualitative Killing Effect on Bacterial (Propagules/Spore) Carriers 
4. Qualitative Killing Effect on Bacterial (Propagules/Spore) Suspension 
5. Factors Affecting the Efficacy of Veterinary Disinfectants 
6. Damage to Metals by Veterinary Disinfectants 
7. Air Spray Disinfection by Veterinary Disinfectants (Specific Bacteria) 
8. Disinfection of Drinking Water for Livestock and Poultry (Specific Bacteria) 
9. Carrier Disinfection by Veterinary Disinfectants (Specific Bacteria) 
10. Field Disinfection of Surfaces in Livestock and Poultry Pens (Specific Bacteria) 
11. Field Disinfection of Surfaces in Livestock and Poultry Pens 
12. Field Disinfection of Natural Bacterial Air Pollution in Livestock and Poultry Pens 
13. Field Disinfection of Drinking Water for Livestock and Poultry 
14. Quantitative Killing Effect on Viruses (Chicken Embryo Method) 
15. Quantitative Killing Effect on Viruses (Cell Method) 
16. Identification of Neutralizers in Disinfectants 

Key Components of the Templates

Each template is meticulously structured to provide a comprehensive evaluation of disinfectants. The key components include: 

1. Purpose of the Test: Briefly describe the purpose of the test 

2. Basis of Test: Conducted per: 

• “Technical Specifications for the Identification of Veterinary Disinfectants” (Agricultural and Animal Husbandry Medicine [1992] No. 101) 
• “Quality Management Standards for Clinical Trials of Veterinary Drugs” (Announcement [2015] No. 2337 of the Ministry of Agriculture) 
• and other relevant laws and regulations 

3. Test Duration ：Describe the start and end of the experiment and when each step was performed 

4. Test Location: Description of the place where the test was carried out and its address. 

5. Experimenters: List of participants and their roles. 

6. Test Materials: 

• Investigational Drugs: Details of the disinfectant under test and the control disinfectant, including product name, active ingredient, specifications, batch number, production unit, dates, storage conditions, and usage methods. 
• Test Strains: Name and source of the test strain. 
• Reagents, Instruments, and Consumables: Formulations and preparation methods of neutralizers and buffers, along with details of media, reagents, consumables, instruments, and equipment used. 

7. Test Methods: Detailed description of the methodology of the test 

8. Test Results and Analysis: Results are presented in tabular form, analyzing the disinfection effect. 

9. Conclusions: Summary of trial conclusions. 

10. Test Quality Control: 

• Training of Test Personnel: Training content for testers. 
• Implementation of the Pilot Programme: Description of any protocol deviations and their impacts. 
• Test Monitoring and Co-Investigation: Details of monitoring and co-inspection during the trial. 
• Data Logging and Archiving: Recorded content and archive address. 

11. Laboratory Biosafety: Details of any biosafety issues and resolutions. 

12. References: List of references involved in the trial. 

13. Schedule: Original test results are attached. 

Implications for Veterinary Drug Manufacturers 

For regulatory affairs managers in veterinary drug manufacturing, these templates are essential tools to ensure compliance with Chinese regulatory standards. They provide a standardized approach to testing and documentation, facilitating smoother registration processes and enhancing the credibility of efficacy claims. 

Manufacturers are encouraged to integrate these templates into their testing protocols immediately. By adhering to these standardized guidelines, they can ensure that their disinfectants meet the rigorous standards set by Chinese regulators, thereby streamlining the approval process and reducing the risk of non-compliance. 

For additional information or guidance on implementing these templates, manufacturers can contact Cisema experts or refer to the original announcement and related regulatory documentation. 

Further information 

Read the original announcement on 16 Veterinary Disinfectant Test Report Templates.  

Read our previous article on China Veterinary Drug Comparative Test Requirements – No.787. 

By staying informed and adapting to these regulatory changes, veterinary drug manufacturers can continue to ensure the safety and efficacy of their products, contributing to improved animal health and public safety. 

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