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| 实施百白破疫苗同步批签发监管的回顾性研究 |
| A retrospective study on the implementation of the synchronous lot release of DTaP vaccine |
| 投稿时间：2020-05-09 修订日期：2021-01-14 |
| DOI： |
| 中文关键词: 疫苗，百白破，批签发，回顾 |
| 英文关键词: Vaccine DTaP, Lot release Retrospect |
| 基金项目:国家科技重大专项重大新药创制(2018ZX09738005) |
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| 中文摘要: |
| 为保障一类疫苗的市场供应,于2019年年初开通了疫苗同步批签发通道。目前为止,已有3家企业生产的吸附无细胞百白破联合疫苗产品实施同步批签发。本文主要以百日咳疫苗为例,回顾性分析该产品在实施同步批签发以后产品质量的一致性、稳定性；中检院在抽样检验时的主要考量依据；以及企业关键自检数据与中检院抽检数据的对比。为同步批签发的应用提供数据积累。 |
| 英文摘要: |
| In order to ensure the market supply of Class I vaccines, a synchronous vaccine lot release started in early 2019. So far, absorbed Diphtheria,Tetanus and acellular Pertussis Combined Vaccine products produced by three manufacturers have been implemented synchronous lot release. This article mainly takes pertussis vaccine as an example to retrospectively analyze the consistency and stability of the product quality after the synchronous lot release; the main considerations of NIFDC during sampling inspection; and the comparison between the company"s key self-testing data and NIFDC’s testing data. This will provide data accumulation for applications of the synchronous lot release. |
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