生物制品实验室间检测结果对比分析在批签发管理中的应用

Application of data comparison analysis in lot release

生物制品实验室间检测结果的对比分析是指应用统计学的方法对国家质量控制实验室(NCL)与企业质量控制实验室检测的制品的重要质量控制数据进行比较。该分析可以有效地保证产品质量的一致性,比较检测过程是否有效运行,确定影响合格/不合格判定的潜在因素,在批签发管理中具有重要的作用。WHO明确要求NCL应对产品的关键质量参数进行实验室间检测结果的对比分析,对于系统差异应记录,对于不符合和趋势偏差较大的应进行分析调查,查找引起偏差的原因,制订纠正和预防措施。

Data comparison analysis means comparing results of the quality control test between the NCLs and manufactures,which is very important in lot release. The aims of data comparison analysis between the NCL and manufacturers are to confirm the consistency of the vaccine quality,to compare the method performance,and to determine the potential risk of different justification on pass /fail. In the Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities from WHO point out that NCL should apply the data comparison analysis in lot release. The deference must be recorded and the CAPA must be drawn up.