1 回答
No. Analytical methods should be accurate and precise.16 For most lab analyses, reprocessing data should not be regularly needed. If chromatography is reprocessed, written procedures must be established and followed and each result retained for review (see §§ 211.160, 211.165(c), 211.194(a)(4), and 212.60(a)). FDA requires complete data in laboratory records, which includes but is not limited to notebooks, worksheets, graphs, charts, spectra, and other types of data from laboratory instruments (§§ 211.194(a) and 212.60(g)(3)).
不可以。分析方法应准确且精确16。对于多数实验室分析，应该无需经常对数据进行再处理。如果对色谱进行了再处理，则必须建立和遵循书面程序，并保留每一结果供审核(见第211.160、211.165(C)、211.194(A)(4)和212.60(A)节)。FDA要求实验室记录中有完整的数据，包括但不限于笔记本、工作表、图表、光谱和其他类型的实验室仪器数据(§211.194(A)和212.60(G)(3)。
