包裝批記錄的簽發(fā)與流轉(zhuǎn)-文庫吧資料
2025-08-09 01:25本頁面
【正文】 d to packaging. 詳細(xì)步驟 Detailed stepsID操作步驟（什么）Action (What)誰(職責(zé))Who(func.)控制,指標(biāo),規(guī)則（QA, EHS, Fi…）Controls, KPIs, Rules (QA,EHS,Fi…)1包裝批記錄交給QAsubmit BR to QA價值流協(xié)調(diào)VSCN/A2批準(zhǔn)包裝批記錄approve BRQA216。 單盒打印激光機選用固定模板,單盒批號效期打印區(qū)域右側(cè)打印大寫字母”E”,樣張參見附件2—該字樣表示為”滲透產(chǎn)品”.單盒批號效期打印區(qū)域右側(cè)打印大寫字母”S”,樣張參見附件2—該字樣表示為”贈送產(chǎn)品”. chose the dedicated template in the Carton Laser Jet machine, print the letter “E”(penetration product)/ letter ”S”(Present product) on the carton at the right side of printing area , refer to appendix 2 for the examples216。 包裝批記錄簽發(fā)之時,根據(jù)該批的批量進(jìn)行下載相應(yīng)藥品監(jiān)管碼,并拷貝到存儲卡中,交給線長.When issuing BR, copy the correlative downloaded product ID code to CF card , hand it to the line leader.注:在發(fā)放藥監(jiān)碼時,發(fā)放人員需要進(jìn)行對藥監(jiān)碼進(jìn)行確認(rèn)該文件的屬性,判斷是否為當(dāng)前新下載文件,杜絕重復(fù)使用.Note: when delivering the ID datum, VSC must check the folder’s properties, whether is new create date or not, in order to avoid using repeated datum. 3.特殊產(chǎn)品需求包裝Package requirement for FG價值流協(xié)調(diào)VSC216。 the NICPBP FIFO, except for special cases216。 取樣批量按抽樣量發(fā)放Sampling batch qty as per NICPBP sampling qty批記錄簽發(fā)時應(yīng)注意:Note during issue BR:216。 半成品批量基本根據(jù)訂單需求制定，PFS裝疫苗按整盒發(fā)放,VIAL裝疫苗可拆零發(fā)放，每盒Akilux最多只能拆一次零頭The rule for SFG allocation is mainly as per sales order, the vaccines with PFS presentation must be sent to PK with full box, for vial presentation, the partial quantity is allowed but only for once. 216。The new pack sequence numbers are used for EPI package ,rework ,unpack , NICPBP sampling and visual inspection.216。The pack sequence number is Arabic number with seven digits .The first four digits stand for Year, . 2009 stand for the year of 2009. The last three digits stand for the sequent number which begins from number 001.216。 包裝流水號由七位阿拉伯?dāng)?shù)字組成，前四位阿拉伯?dāng)?shù)字代表年份，如: 2009代表2009年度。VSC is responsible for preparing the batch record.QA is responsible for approving the batch record.Packaging is responsible for archiving the approved batch record until submitted to QA
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