一、Quality- Traceability
    LTO驗廠品質(zhì)-可跟蹤性
1.Traceability - Raw Material Identification
  可跟蹤性-原材料確認
2.Raw Material shall be traceable
  原材料應當是能夠跟蹤的
3.Traceability - Traceability of Processing Stages
  可跟蹤性-加工階段的可跟蹤性
4.Process steps shall be traceable
  加工步驟應當是可以跟蹤的
5.Traceability - Traceability of Finished Product
  可跟蹤性-成品可跟蹤性
6.Units of Sale and Outer Cases shall have a Lot Code
  銷售單元和外箱上應有批號代碼
7.Outer Pack shall have a code
  外包裝上應有代碼
8.Coding on outer packs shall be legible
  外包裝代碼應清晰可辨
9.Goods shall be traceable to first paying customer
  貨物應當可以跟蹤到最初付款的客戶
10.Traceability - Despatch & Distribution
   可跟蹤性-發(fā)貨與配送
11.Traceability system shall be regularly tested & records kept
   可跟蹤性系統(tǒng)應定期得到檢測并保留記錄
12.Records shall be kept
   應保留記錄
13.The traceability management system shall be developed using a consistent & rigorous methodology
   可跟蹤性管理系統(tǒng)應以一致、嚴格的方式建立

二、Quality- Laboratory Management
    LTO驗廠品質(zhì)-實驗室管理
1.Laboratory Management
  實驗室管理
2.The laboratory shall operate a System of Good Laboratory Practice
  實驗室系統(tǒng)的運作應符合良好實驗室規(guī)范