bios中英文对照表 CGMP 中英文对照.doc
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bios中英文对照表 CGMP 中英文对照
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Question 125 CFR 111.310
Laboratory facilities used are adequate for testing of components, in-process materials, and dietary supplements.
使用足够的测试组分,使用的材料与膳食补充剂的实验室设施
? a. Contract laboratories shall provide documented results including actual results, methods used, reference standards used if applicable, names and dates.
?分包实验室须提供测试结果的文件,包括实际结果,使用方法,适用时参考的标准,姓名与日期。 ? b. In house lab facilities are clean and orderly. In full operation, there should be no overlap of testing procedures occurring at the same time.
? 实验室设施是清洁与整齐的。相同时间内不能有重叠的测试程序。
? c. Equipment (instruments, water systems, etc.) have unique identification, are adequate for intended use and calibration and maintenance is up to date.
? 仪器,水系统等设备有唯一的标识,满足预期的应用,最近的校正与维护。
? d. Areas for storing reference standards, supplies and reagents are adequately controlled and segregated. In some cases, humidity, temperature, light or other environmental factors may need to be controlled.
?储存参考标准,供应品与试剂的区域应受控与隔离。有时湿度,温度,光照与其他环境因子应受控。
? e. Calibration standards, such as standard weight sets for analytical balances, are properly maintained. ? 如分析天平的标准重量设置等校正标准应正确维持。
Question 126 CFR 111.310
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