| 摘要: |
| 就疫苗中污染外源病毒的 情况、外源病毒传统检测技术及新型分子检测技术等进行了综述，并提出通过严格按照GMP规范组织生产，加强对菌(种)毒和细胞库的质量控制，严格控制生产检验原材料质量，进一步完善标准方法、提高检验水平，开展外源因子风险评估研究等措施以降低污染风险。 |
| 关键词: 疫苗 外源病毒 检测方法 控制措施 |
| DOI： |
| 投稿时间：2014-07-08修订日期：2014-11-02 |
| 基金项目:948项目-兽药监察关键技术引进［(2011)-G(3)］ |
|
| Contamination of Extraneous Virus in Viral Vaccine and Detection Methods, Purification Control Strategies |
|
| (China Institute of Veterinery Drug Control,Beijing,100081) |
| Abstract: |
| The history and present situation, convetional detection assays and new molecular assays about were reviewed in this paper. Purification control strategies including operation strictly according GMP specification, enhancing management of virus seeds, strict quality control of raw material, improving and constituting standard assays, improving test level, and carrying out some risk analysis on extraneous pathogens were suggested in order to ensure purity of vaccine. |
| Key words: vaccine extraneous pathogens detection methods control strategies |
