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您可以边看文字和视频，双重记忆保障、学习更牢固。 您也可以放松双眼，让给耳朵享受美妙、纯正的中英文听力。 重大缺陷 Major deficiency [Source 来源: EMA] GMP Inspection Report – Union Format, EMA A non-critical deficiency: • which has produced or may produce a product, which does not comply with its marketing authorisation; • or which indicates a major deviation from EU Good Manufacturing Practice; • or (within EU) which indicates a major deviation from the terms of the manufacturing authorisation; • or which indicates a failure to carry out satisfactory procedures for release of batches or (within EU) a failure of the Qualified Person to fulfil his legal duties; • or a combination of several "other" deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such. 一种非严重缺陷： • 生产或可能生产不符合其
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