LTO验厂品质科跟踪性及实验室管理
2018-03-02
一、Quality- Traceability
LTO验厂品质-可跟踪性
1.Traceability - Raw Material Identification
可跟踪性-原材料确认
2.Raw Material shall be traceable
原材料应当是能够跟踪的
3.Traceability - Traceability of Processing Stages
可跟踪性-加工阶段的可跟踪性
4.Process steps shall be traceable
加工步骤应当是可以跟踪的
5.Traceability - Traceability of Finished Product
可跟踪性-成品可跟踪性
6.Units of Sale and Outer Cases shall have a Lot Code
销售单元和外箱上应有批号代码
7.Outer Pack shall have a code
外包装上应有代码
8.Coding on outer packs shall be legible
外包装代码应清晰可辨
9.Goods shall be traceable to first paying customer
货物应当可以跟踪到最初付款的客户
10.Traceability - Despatch & Distribution
可跟踪性-发货与配送
11.Traceability system shall be regularly tested & records kept
可跟踪性系统应定期得到检测并保留记录
12.Records shall be kept
应保留记录
13.The traceability management system shall be developed using a consistent & rigorous methodology
可跟踪性管理系统应以一致、严格的方式建立
二、Quality- Laboratory Management
LTO验厂品质-实验室管理
1.Laboratory Management
实验室管理
2.The laboratory shall operate a System of Good Laboratory Practice
实验室系统的运作应符合良好实验室规范
