辨析GLP体系中的变更与偏离

Discrimination on the Amendment and Deviation in GLP Systems

目的:辨析不同GLP体系中变更与偏离的定义、区别与联系,使研究人员对不同GLP体系中变更与偏离的理解更加深刻,运用更为准确。方法:依据国家药品监督管理局(NMPA)、经济合作与发展组织(OECD)、美国食品药品监督管理局(FDA)颁布的GLP规范,从变更与偏离的定义入手,分析两者之间的关系和异同。结果与结论:变更和偏离是GLP体系中常用的两个定义,二者之间有较为明显的区别,但有时也会出现联动,较常见的是由偏离引发的变更。

Objective: To discriminate the definitions, differences and associations of amendment and deviation in different GLP quality systems, to help the GLP relevant personnel have a deeper understanding of the amendment and deviation and use them properly. Methods: According to the definitions of amendment and deviation in the GLP principles issued by NMPA, OECD and FDA, the relationship and differences between amendment and deviation were analyzed. Results and Conclusion: Amendment and deviation are two common terms in the GLP system, and there are obvious differences between them. Sometimes there are linkages and the amendment which is commonly caused by deviation.