中国科技术语 ›› 2020, Vol. 22 ›› Issue (4): 53-58.doi: 10.3969/j.issn.1673-8578.2020.04.010
李嫣然(
), 甘珏()
LI Yanran(), GAN Jue()
摘要：
针对当前药品质量管理中validation、verification和qualification容易混淆和误译的现象,借助语料库软件AntConc,并经ABBYY Aligner处理,结合搭配理论,探讨这三个术语的语义区别以及如何规范化。建议在药品质量管理中,validation译为“验证”,verification译为“确证”,当探讨杂质问题时,qualification译为“界定”,涉及设备或辅助系统时,qualification译为“确认”。
Abstract:To identify the subtle semantic differences between validation,verification and qualification in the pharmaceutical quality management and correct translation chaos. Guided by the Collocation Theory, this paper tries to probe into this field from the perspective of semantics with the aid of the software AntConc, ABBYY Aligner. It is suggested that validation, verification should be translated as “yanzheng(验证)”and“quezheng(确证)”. And qualification should be translated into “jieding(界定)”when it is related to impurity issues, whereas “queren(确认)”in equipment or ancillary systems settings.
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