包裝批記錄的簽發(fā)與流轉(zhuǎn)(已修改)
2025-08-15 01:25 本頁(yè)面
【正文】 總頁(yè)數(shù):11頁(yè)(9頁(yè)＋2個(gè)附件:2頁(yè))Total pages: 11pages (9pages + 2appendicx : 2pages)目錄 TABLE OF CONTENTS:1. 目的 OBJECTIVE 22. 范圍 SCOPE 23. 職責(zé) RESPONSIBILITIES 24. 步驟 PROCEDURE 3 流程圖 Flowchart 3 包裝批記錄的簽發(fā)Batch Record issuing 4 包裝批記錄的流轉(zhuǎn)Batch Record circulation 6 定期數(shù)據(jù)回顧 Periodic Process Review 85. 術(shù)語(yǔ) GLOSSARY 96. 參考文件 REFERENCES 97. 附件 APPENDIX 98. 其他相關(guān)信息 RELATED FORMS AND TRAINING MATERIAL 9 表格 Forms 9 培訓(xùn)資料Training Material 913 / 131. 目的 OBJECTIVE描述開始生產(chǎn)操作前，包裝批記錄簽發(fā)給生產(chǎn)部門的流程To describe the process to issue batch record to the Packaging Department for starting packaging operations.2. 范圍 SCOPE在上海葛蘭素史克生物制品的所有包裝操作The procedure is applicable to packaging operations in GSKBS3. 職責(zé) RESPONSIBILITIES價(jià)值流部門負(fù)責(zé)包裝批記錄的準(zhǔn)備。QA 負(fù)責(zé)包裝批記錄的批準(zhǔn)。包裝部門負(fù)責(zé)包裝批記錄的歸檔，直至批記錄完成后交給質(zhì)保部。價(jià)值流部門負(fù)責(zé)整個(gè)流程的追蹤。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 with finalized BR.VSC is accountable for all the process. 4. 步驟 PROCEDURE 流程圖 Flowchart在本SOP中In this SOP在相關(guān)SOP中Not in this SOP問(wèn)題QuestionYes定期數(shù)據(jù)回顧Periodic Process Review情況異常？Abnormality?參考QA053(風(fēng)險(xiǎn)管理)或QA028(異常事件及調(diào)查處理) Refer to QA053 (Risk Mgt) or QA028 (Incident amp。 Investigation mgt)包裝批記錄是否正確If Batch Record correct包裝批記錄的流轉(zhuǎn)Batch Record circulationNoYes包裝批記錄的簽發(fā)Batch Record issuing 包裝批記錄的簽發(fā)Batch Record issuing 介紹Introduction N/A 詳細(xì)步驟 Detailed stepsID操作步驟（什么）Action (What)誰(shuí)(職責(zé)）Who(func.)控制,指標(biāo),規(guī)則（QA, EHS, Fi…）Controls, KPIs, Rules (QA,EHS,Fi…)1.根據(jù)生產(chǎn)計(jì)劃在半個(gè)工作日前簽發(fā)包裝批記錄.Issue BR as per production planning at latest half of working day before operation 價(jià)值流協(xié)調(diào)VSC包裝流水號(hào)編號(hào)原則如下：Number principle of batch record as follow:216。 包裝流水號(hào)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。后三位阿拉伯?dāng)?shù)字為流水號(hào)，從001開始。The pack sequence number is Arabic number with seven digits .The firs
教學(xué)課件相關(guān)推薦
鄂ICP備17016276號(hào)-1