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发表于 2019-8-23 18:28:55
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通篇翻译比较流畅。但是有严重翻译错误:
Sec. 211.105 Equipment identification.
211∙105设备鉴别
(a) All compounding and storage containers, processing lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch.
(a) 在整个生产周期内,同批药品生产使用的全部混合和贮存容器、生产线和主要设备应严格识别,标示出药品的成份,需要时,不须标出所处的加工阶段。
properly译为“严格”不恰当。
when necessary, the phase of processing of the batch。应译为“需要时,应当标出所处的加工阶段。
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