歐盟藥品流通法規(guī)詳述-在線瀏覽
2024-11-04 01:53本頁面
【正文】 s 記錄 Made when each operation is taking place 每次操作時均應(yīng)記錄 Activities and events are traceable 活動/事件均可追蹤 Readily available 方便查閱 Retained for 5 years at least 至少保存(bǎocnji224。,Records Cont’d 記錄(續(xù)) Transactions between 以下交易的記錄： (i) Manufacturers and Wholesalers 制造企業(yè)(qǐy232。) (ii) Between Wholesalers 批發(fā)企業(yè)之間 ensure traceability of origin/destination products i.e. Batch numbers to identify suppliers and those supplied with medicinal products 能保證產(chǎn)品起點(diǎn)/終點(diǎn)的追蹤性，如用批號來識別供給商及其發(fā)的藥品,Documentation 文件(w233。n),第十頁，共四十六頁。)損壞 corresponds to the order 與定單是否相符,Premises and Equipment 庫房設(shè)施(sh232。,Storage 儲存 Medicinal products separate from other goods 藥品與其它產(chǎn)品分開 Conditions specified protect from light, moisture, below 25℃ 規(guī)定條件(ti225。n)避光,防潮,低于25℃ Temperature monitoring documented 溫度監(jiān)測有記錄 Records reviewed regularly 定期審核記錄 Temperature Mapping. Storage areas/cold rooms 溫度分布、儲存區(qū)/冷庫,Premises and Equipment 庫房設(shè)施(sh232。,Ensure all locations within specific temperature range 保證所有區(qū)域(qūy249。shī)與設(shè)備,第十三頁，共四十六頁。n)、蟲害 Free from spillage or breakage 沒有溢出或損壞 Microcontamination 微生物污染 Cross contamination 穿插污染 Stock Rotation 庫存流轉(zhuǎn) “First in First out〞 Regular checks “先進(jìn)先出〞定期檢查,Premises and Equipment 庫房(k249。ng)設(shè)施與設(shè)備,第十四頁，共四十六頁。l237。f225。,Authorised Wholesalers 批準(zhǔn)的批發(fā)商 Persons authorised to supply Medicinal Products 經(jīng)批準(zhǔn)可從事藥品流通的人員 IMB will look randomly at customer list 愛爾蘭藥品管理局將在客戶清單中隨機(jī)抽查 Supply Document 提供的文件應(yīng)有： Date 日期 Name and Pharmaceutical Form 名稱與藥品劑型(j236。ng) Quantity supplied 供給數(shù)量,Deliveries to Customers 向客戶(k232。)發(fā)貨,第十六頁，共四十六頁。zhǐ) Name and address 名稱與地址 Product Shelf Life 產(chǎn)品有效期 Product dispatched must have a minimum defined shelf life remaining 所發(fā)送的產(chǎn)品必須具有所規(guī)定最短有效期,Deliveries to Customers 向客戶(k232。)發(fā)貨,第十七頁，共四十六頁。 theft are avoided 防止損壞與偷竊 Protected from unacceptable environmental conditions 防止環(huán)境條件(ti225。n)不符合要求 Temperature is controlled during transport 在運(yùn)輸中溫度受控,Deliveries to Customers 向客戶(k232。)發(fā)貨,第十八頁，共四十六頁。xū)在以下條件下發(fā)運(yùn) Refrigerated transport 冷凍運(yùn)輸 Insulated boxes 絕熱箱 Validate worst case situation during transport 驗(yàn)證在運(yùn)輸中最壞情況狀態(tài) Ensure product does not come in contact with ice packs 保證產(chǎn)品不接觸冰袋 Responsible Person ensure adequate delivery conditions maintained 負(fù)責(zé)人保證保持足夠的交付條件,Deliveries to Customers 向客戶(k232。)發(fā)貨,第十九頁，共四十六頁。ng)單獨(dú)發(fā)送方式，方便移交 Deliver direct to pharmacist at the hospital or retail outlet 直接交到醫(yī)院或零售店的藥劑師,Deliveries to Customers 向客戶(k232。)發(fā)貨,第二十頁，共四十六頁。n)藥品 Segregation from Saleable Stock until checked 與銷售庫存相隔離，直到經(jīng)過檢查 Products in good condition original unwrapped containers 產(chǎn)品保持良好狀態(tài) 容器為原始包裝未經(jīng)開封 Products stored under proper conditions 產(chǎn)品在正確條件下儲存 Remaining shelf life acceptable 仍有可承受的有效期,Returns 退貨(tu236。),第二十一頁，共四十六頁。n)條件自從發(fā)貨起的持續(xù)時間 Maintain records of returned goods 保存退貨記錄 Return to stock operating FIFO System 退回倉庫，按先進(jìn)先出要求管理,Returns 退貨(tu236。),第二十二頁，共四十六頁。 recorded by Responsible Person 決定文件
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