National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Republic of Korea; School of Pharmacy, Chungbuk National University, Cheongju, Republic of Korea.
National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Republic of Korea.
Biologicals. 2022 Jun;77:24-27. doi: 10.1016/j.biologicals.2022.05.002. Epub 2022 Jun 2.
Independent quality testing of samples from vaccine lots is part of quality assurance, especially to ensure the consistency of production lot by lot. Effective national lot release system that ensures the quality of each lot of vaccine before it is on the market is important because vaccines are intended to healthy people. In order to respond more quickly to public health crises such as the COVID-19 pandemic, the MFDS implements accelerated national lot release for rapid vaccination in Republic of Korea. For the accelerated system, improvement has been made in terms of timing of application for lot release and required documents. In addition, the processing period has been shortened and sampling method and test items have been streamlined. A thorough preparation for accelerated lot release has been developed by establishing test methods for a new platform in advance. As a result, a total of 43.88 million doses have been released within eight days on average. The accelerated lot release system has contributed significantly to rapid COVID-19 vaccination in Korea.
疫苗批次的独立质量检测是质量保证的一部分，特别是为了确保每批生产的一致性。建立有效的国家批放行体系，确保每批疫苗在上市前的质量，这一点很重要，因为疫苗是为健康人群设计的。为了更迅速地应对 COVID-19 大流行等公共卫生危机，韩国食品医药品安全处（MFDS）在韩国实施了加速国家批放行，以实现快速接种。对于加速系统，在批放行申请时间和所需文件方面进行了改进。此外，处理周期已经缩短，抽样方法和测试项目也得到了简化。通过预先建立新平台的测试方法，为加速批放行做了充分准备。结果，平均在 8 天内总共放行 4388 万剂疫苗。加速批放行系统为韩国 COVID-19 的快速疫苗接种做出了重大贡献。
