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本文论述了质量保证(QA)在长期毒性试验原始资料核查过程中的关注点和主要问题,包括方案、报告和原始记录的一致性、原始资料记录的规范性和准确性、数据核查和资料保存等。分析问题产生的原因,主要归结于GLP意识不强、GLP依从性和SOP的执行力差。对减少问题发生提出了建议和措施,包括加强GLP培训、提高对GLP和SOP的依从性、计算机化仪器系统的运用和专家对GLP单位实施“飞行检查”等。
This article discusses the focus and major issues of quality assurance (QA) in the verification of raw data for long-term toxicity testing, including the consistency of protocols, reports and original records, the normativity and accuracy of raw data records, data verification and data retention Wait. Analysis of the causes of the problem, mainly due to GLP awareness is not strong, GLP compliance and SOP poor execution. Suggestions and measures were put forward to reduce the problems, including strengthening GLP training, improving compliance with GLP and SOP, using computerized instrumentation systems and implementing “flight check” for GLP units by experts.