疫苗派驻检查员派驻期间的关注点浅析

A Brief Analysis of the Concerns of Vaccine Resident Inspectors

目的根据笔者作为疫苗派驻检查员在疫苗生产企业开展派驻检查的工作实践和经验,对疫苗派驻检查员在日常派驻检查过程中的关注点进行分析,为今后疫苗派驻检查员的日常工作提供一些思路和借鉴。方法对日常GMP督查、批间一致性控制、全过程无菌控制、生物安全防控、上市后变更等关键项目逐项开展派驻检查的关注点分析。结果识别日常派驻检查关注点并进行了简要分析。结论本文提出的派驻检查关注点可为今后疫苗派驻检查管理制度的制定和完善及其他派驻检查员的日常工作提供可参考和借鉴的思路。

OBJECTIVE According to the practice and experience of the author as a vaccine resident inspector in a vaccine manufacturer,to analyze the concerns of vaccine resident inspectors in the daily resident inspection,and to provide some ideas and reference for the daily inspection in the future.METHODS The concerns such as routine GMP supervision,batch-to-batch consistency,whole-process aseptic control,bio-safety prevention,and post-approved changes were analyzed one by one.RESULTS Daily resident inspection concerns were identified and briefly analyzed.CONCLUSION The concerns of resident inspection proposed in this paper can provide some reference and ideas for the preparation and improvement of the management system of resident inspection of vaccines in the future and the daily work of other resident inspectors.