LTO驗(yàn)廠品質(zhì)科跟蹤性及實(shí)驗(yàn)室管理
一、Quality- Traceability
LTO驗(yàn)廠品質(zhì)-可跟蹤性
1.Traceability - Raw Material Identification
可跟蹤性-原材料確認(rèn)
2.Raw Material shall be traceable
原材料應(yīng)當(dāng)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(yīng)當(dāng)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(yīng)有批號(hào)代碼
7.Outer Pack shall have a code
外包裝上應(yīng)有代碼
8.Coding on outer packs shall be legible
外包裝代碼應(yīng)清晰可辨
9.Goods shall be traceable to first paying customer
貨物應(yīng)當(dāng)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(yīng)定期得到檢測并保留記錄
12.Records shall be kept
應(yīng)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(yīng)以一致、嚴(yán)格的方式建立
二、Quality- Laboratory Management
LTO驗(yàn)廠品質(zhì)-實(shí)驗(yàn)室管理
1.Laboratory Management
實(shí)驗(yàn)室管理
2.The laboratory shall operate a System of Good Laboratory Practice
實(shí)驗(yàn)室系統(tǒng)的運(yùn)作應(yīng)符合良好實(shí)驗(yàn)室規(guī)范