今日药学

2021, v.31(12) 935-937

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GLP实验室QA对Provantis系统检查要点的探讨
Discussion on Key Points of Provantis System Inspection by QA in GLP Laboratory

潘秋兰;孙昊;吴紫君;王思铭;郭健敏;雷夏凌;杨威;
PAN Qiulan;SUN Hao;WU Zijun;WANG Siming;GUO Jianmin;LEI Xialing;YANG Wei;Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.,Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research,Guangdong Engineering Research Center for Innovative Drug Evaluation and Research,TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine;

摘要(Abstract):

为提高药物非临床研究数据的准确性、可靠性、安全性以及可追溯性,如今,Provantis系统在药物非临床安全性评价领域应用愈发广泛,Provantis系统在给遵循药物非临床研究质量管理规范(good laboratory practice, GLP)法规的试验带来的便捷、准确、可靠的支撑的同时,也给试验和管理的流程以及质量保证(quality assurance, QA)的检查带来了新的挑战。本文结合本机构质量保证部门(quality assurance unit, QAU)对Provantis系统的检查情况,对Provantis系统的验证、使用过程的检查要点进行探讨,同时对保证QA对系统进行充分的质量保证提出一些建议,以期通过研究者不断学习以及交流,规范Provantis系统检查的质量保证流程,维护良好的GLP试验状态。
In order to improve the accuracy, reliability, safety, and traceability of non-clinical drug studies, Provantis system is widely used in the field of drug non clinical safety evaluation.Provantis provides convenient, accurate, and reliable support for good laboratory practice(GLP) compliance.It also brings new challenges to the test and management process and quality assurance(QA) inspection.Based on the inspection of Provantis system by quality assurance unit(QAU),this paper discusses the verification and inspection points of Provantis system, and puts forward some suggestions to ensure that QA can fully guarantee the quality of the system.To standardize the quality assurance process of Provantis system inspection and maintain good GLP test status through researchist continuous learning and communication.

关键词(KeyWords): Provantis系统;药物非临床研究质量管理规范;质量保证
Provantis system;good laboratory practice;quality assurance

Abstract:

Keywords:

基金项目(Foundation): 广东省省级科技计划项目(2018B030323024);; 广东省重点领域研发计划项目(2019B020202001)

作者(Authors): 潘秋兰;孙昊;吴紫君;王思铭;郭健敏;雷夏凌;杨威;
PAN Qiulan;SUN Hao;WU Zijun;WANG Siming;GUO Jianmin;LEI Xialing;YANG Wei;Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.,Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research,Guangdong Engineering Research Center for Innovative Drug Evaluation and Research,TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine;

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