In order to strengthen the bio-safety management of veterinary vaccine production, standardize the bio-safety level three-level inspection and acceptance of veterinary vaccine production enterprises, according to the “three-level protection standard for bio-safety of veterinary vaccine production enterprises” (Ministry of Agriculture Announcement 2573) No.), the Ministry of Agriculture and Rural Organizations has formulated the “Evaluation Standard for Biosafety Level 3 Protection Inspection and Acceptance for Veterinary Vaccine Production Enterprises” (hereinafter referred to as “Assessment Standards”).
1. The provincial veterinary administrative department is responsible for organizing the three-level protective inspection and acceptance of biosafety for veterinary vaccine manufacturers. The inspection and acceptance experts are selected in the veterinary GMP inspector library (veterinary biological products group) of the Ministry of Agriculture and Rural Areas. If necessary, experts from relevant fields such as biosafety may be invited to participate in the inspection and acceptance work.
2. The veterinary vaccine production enterprise bio-safety three-level protective inspection and acceptance and veterinary drug GMP inspection and acceptance can be carried out at the same time, can also be carried out after veterinary drug GMP inspection and acceptance, and its inspection and acceptance procedures are carried out in accordance with the veterinary drug GMP inspection and acceptance procedures.
3. The veterinary vaccine production enterprise bio-safety level three inspection inspection and acceptance and veterinary drug GMP inspection acceptance results assessment, should be assessed according to the corresponding standards, but not cumulative calculation and assessment, respectively, the project defect table and on-site inspection acceptance report.
4. The production line that needs to pass the biosafety level 3 protection inspection and acceptance of veterinary vaccine production enterprises in accordance with the regulations of the Ministry of China shall not be included in the production scope of the enterprise “Veterinary Drug GMP Certificate” and “Veterinary Drug Production License”. The production line that has been included in the production scope before the implementation of the regulations will not pass the inspection and acceptance until the deadline for the relevant regulations. The provincial veterinary administrative department shall cancel the corresponding production scope of the enterprise veterinary drug GMP certificate and veterinary drug production license.