歐盟藥品gdp及藥品冷鏈技術(shù)(1)(編輯修改稿)
2025-02-08 23:35 本頁面
【文章內(nèi)容簡介】 e delivery conditions maintained 負責人 保證保持足夠的交付條件 Deliveries to Customers 向客戶發(fā)貨 – Controlled Drugs 受控藥物 Maintain Security Chain 保持發(fā)貨各環(huán)節(jié)的安全 187。Separate control drugs in deliveries to facilitate transfer 受控藥品要采用單獨發(fā)送方式，方便移交 187。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 向客戶發(fā)貨 Non Defective Medicinal Products 無缺陷藥品 – Segregation from Saleable Stock until checked – 與銷售庫存相隔離，直到經(jīng)過檢查 187。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 187。Products stored under proper conditions 產(chǎn)品在正確條件下儲存 187。Remaining shelf life acceptable 仍有可接受的有效期 Returns 退貨 u Products examined and assessed by authorised, trained personnel 產(chǎn)品由經(jīng)過批準及培訓人員的檢測與評估 – Special storage conditions time elapsed since issue 特別儲存條件 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，按先進先出要求管理 Returns 退貨 – Product Disposal 產(chǎn)品處置 Returned, Rejected or Recalled Products 退回，拒絕或召回產(chǎn)品 187。Decision documented recorded by Responsible Person 決定文件與負責人的記錄 187。Disposal in a timely manner 以及時的方式處置 Returns 退貨 ? Conduct and Record Self Inspections to monitor the implementation of and pliance with GDP Guidelines ? 對執(zhí)行流通管理規(guī)范情況進行自檢并做好記錄： 187。Self Inspection Procedure 自檢程序 187。Inspection Reports 檢查報告 187。Follow up Actions 跟蹤 措施 187。Inspection Log 檢查日志 Self Inspection 自檢 ? Quality Management 質(zhì)量管理 – No Quality System available 沒有質(zhì)量系統(tǒng) – No System for Control of Documentation Issue/Retrieval 無系統(tǒng)控制文件的發(fā)放 /與收回 – Master copies SOPS not approved by R. Person 基準 SOP（原版）沒有經(jīng)過負責人批準 – No Policy ： 187。 Minimum acceptable product dating 最短可接受產(chǎn)品有效期 187。Return of refrigerated products 冷凍產(chǎn)品退貨 GDP Deficiencies – General 執(zhí)行流通規(guī)范常中的見缺陷 n Personnel 人員 u Company training programme not available 公司沒有培訓計劃 – No training SOP for GDP operations 沒有培訓流通管理規(guī)范的 SOP u Personnel training not documented 人員培訓沒有記錄 GDP Deficiencies – General 執(zhí)行流通規(guī)范常中的見缺陷 ? Documentation 文件 – Relevant SOPs not available in areas of operation 在操作區(qū)域沒有相關(guān)的 SOP – SOPs not available for 沒有下列 SOP： 187。Receipt and checking of deliveries 對到貨的接收與檢查 187。Warehouse cleaning/pest control 倉庫的清潔 /蟲害控制 187。Temperature monitoring 溫度監(jiān)測 187。Customer plaints 客戶投訴 GDP Deficiencies – General 執(zhí)行流通規(guī)范常中的見缺陷 u Customer plaints not closed out in a timely manner 沒有及時處理（了結(jié)）客戶的投訴 F No customer plaint log maintained 沒有保留客戶投訴記錄 u Service/calibration reports not reviewed 沒有審核校準 / 維修報告 – Pest control reports not reviewed 沒有經(jīng)過審核蟲害控制報告 u Calibration certs acceptable error limit not specified 校準證明 沒有具體規(guī)定誤差限度 GDP Deficiencies – General 執(zhí)行流通規(guī)范常中的見缺陷 ? Premises and Equipment
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