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.