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1、GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Doc. No.: VS001编号：STANDARD OPERATION PROCEDURE标准操作程序Version No.: 9.0版本号包装批记录的签发与流转Batch Record issuing and circulationSuperseded Date: 30/10/2010替代版本日期Page 1 of 9 页数Effective Date: 生效日期SOP in use该流程的执行人The following person is accountable for t
2、he process implementation and output价值流经理 Value Stream Manager总页数:11页(9页2个附件:2页)Total pages: 11pages (9pages + 2appendicx : 2pages)目录 TABLE OF CONTENTS:1.目的 OBJECTIVE22.范围 SCOPE23.职责 RESPONSIBILITIES24.步骤 PROCEDURE34.0流程图 Flowchart34.1包装批记录的签发Batch Record issuing44.2包装批记录的流转Batch Record circulation6
3、4.3定期数据回顾 Periodic Process Review85.术语 GLOSSARY96.参考文件 REFERENCES97.附件 APPENDIX98.其他相关信息 RELATED FORMS AND TRAINING MATERIAL98.1表格 Forms98.2培训资料Training Material9Any printed copy of this document is non-controlled unless it has the blue QA Controlled stampLast saved保存时间11/10/2011 11:45 下午GLAXOSMITHK
4、LINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Doc. No.: VS001编号：Version No.: 9.0版本号Page 3 of 9 页数Effective Date: 生效日期1. 目的OBJECTIVE描述开始生产操作前，包装批记录签发给生产部门的流程To describe the process to issue batch record to the Packaging Department for starting packaging operations.2. 范围SCOPE在上海葛兰素史克生物制品的所有包装操作The pro
5、cedure is applicable to packaging operations in GSKBS3. 职责RESPONSIBILITIES价值流部门负责包装批记录的准备。QA 负责包装批记录的批准。包装部门负责包装批记录的归档，直至批记录完成后交给质保部。价值流部门负责整个流程的追踪。VSC is responsible for preparing the batch record.QA is responsible for approving the batch record.Packaging is responsible for archiving the approved b
6、atch record until submitted to QA with finalized BR.VSC is accountable for all the process.4. 步骤 PROCEDURE4.0 流程图 Flowchart在本SOP中In this SOP在相关SOP中Not in this SOP问题QuestionYes4.5定期数据回顾Periodic Process Review情况异常？Abnormality?参考QA053(风险管理)或QA028(异常事件及调查处理) Refer to QA053 (Risk Mgt) or QA028 (Incident
7、& Investigation mgt)包装批记录是否正确If Batch Record correct4.2包装批记录的流转Batch Record circulationNoYes4.1包装批记录的签发Batch Record issuingGLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Doc. No.: VS001编号：Version No.:9.0版本号Page 8 of 9 页数Effective Date: 生效日期4.1 包装批记录的签发Batch Record issuing4.1.1 介绍Introducti
8、on N/A4.1.2 详细步骤 Detailed stepsID操作步骤（什么）Action (What)谁(职责）Who(func.)控制,指标,规则（QA, EHS, Fi）Controls, KPIs, Rules (QA,EHS,Fi)1.根据生产计划在半个工作日前签发包装批记录.Issue BR as per production planning at latest half of working day before operation 价值流协调VSC包装流水号编号原则如下：Number principle of batch record as follow: 包装流水号由七
9、位阿拉伯数字组成，前四位阿拉伯数字代表年份，如: 2009代表2009年度。后三位阿拉伯数字为流水号，从001开始。The pack sequence number is Arabic number with seven digits .The first four digits stand for Year, e.g. 2009 stand for the year of 2009. The last three digits stand for the sequent number which begins from number 001. 无论用于EPI包装，还是用于返工、拆批、生产中检
10、所取样,目检，都用新的包装流水号编号。The new pack sequence numbers are used for EPI package ,rework ,unpack , NICPBP sampling and visual inspection. 包装批记录上填写第一页的台头部分,并附相应的标准物料单，疫苗/稀释液比利时检验报告封面,每页右上角敲指令号的章.相应数据源参见附件一Fill heading information on the first page of batch record, enclosed with BOM and SFG /diluent COA cove
11、r and stamp the number at top right corner on each page, Data resource refer to appendix 1.批量原则如下:Batch Qty principle as follow: 半成品批量基本根据订单需求制定，PFS装疫苗按整盒发放,VIAL装疫苗可拆零发放，每盒Akilux最多只能拆一次零头The rule for SFG allocation is mainly as per sales order, the vaccines with PFS presentation must be sent to PK w
12、ith full box, for vial presentation, the partial quantity is allowed but only for once. 水针PFS/AMP按配比后整盒发放PFS/AMP diluents after matching must calculate full hypack qty to deliver 取样批量按抽样量发放Sampling batch qty as per NICPBP sampling qty批记录签发时应注意:Note during issue BR: 疫苗选择原则按效期近的先包装,按NICPBP放行次序先放行者先包装,
13、特殊需求除外.the vaccine batch No. issue as per the expired soon& the NICPBP FIFO, except for special cases 稀释液的有效期要比疫苗的有效期长. The validity period of diluent must be longer than the vaccine when issuing BR.2药监码交线长Submit product ID code to line leader 包装批记录签发之时,根据该批的批量进行下载相应药品监管码,并拷贝到存储卡中,交给线长.When issuing
14、BR, copy the correlative downloaded product ID code to CF card , hand it to the line leader.注:在发放药监码时,发放人员需要进行对药监码进行确认该文件的属性,判断是否为当前新下载文件,杜绝重复使用.Note: when delivering the ID datum, VSC must check the folders properties, whether is new create date or not, in order to avoid using repeated datum. 3.特殊产
15、品需求包装Package requirement for FG价值流协调VSC VSC按计划生产渗透产品/赠送产品,必须作为单独批号开一本批记录进行生产,并在批记录抬头注明该产品类型,且分发批记录时按批量必须附上”渗透产品”/”赠送产品”字样标签（每托盘1张）VSC need to open a single BR for penetration /present products, to mark on the title of BR. and must attach to the “Penetration products”/”Present products” label (each p
16、allet needs to stick one label) 单盒打印激光机选用固定模板,-单盒批号效期打印区域右侧打印大写字母”E”,样张参见附件2该字样表示为”渗透产品”.-单盒批号效期打印区域右侧打印大写字母”S”,样张参见附件2该字样表示为”赠送产品”. 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
17、 printing area , refer to appendix 2 for the examples 每托盘生产完后操作工必须将”渗透产品”/”赠送产品”字样标签贴于整托外箱上after packaging one pallet, operator needs to stick the “penetration products” /”present product ”label on the pallet3.1渗透产品Penetration 3.2赠送产品Present 4.2 包装批记录的流转Batch Record circulation4.2.1 介绍Introduction将包
18、装批记录由价值流协调出发，经QA检查，仓库配货，最后流转到包装。 The BR begin with the value stream coordinator ,by QA inspection ,WH handler preparing materials ,at last it is moved to packaging.4.2.2 详细步骤 Detailed stepsID操作步骤（什么）Action (What)谁(职责)Who(func.)控制,指标,规则（QA, EHS, Fi）Controls, KPIs, Rules (QA,EHS,Fi)1包装批记录交给QAsubmit BR
19、 to QA价值流协调VSCN/A2批准包装批记录approve BRQA 参见QA020 refer to QA020 . 若QA检查出BR有误，退回价值流协调，修正后QA重新批准。If the PO has something wrong ,the QA return it to VSC, after the VSC correct it, QA approve it again3交给常温库操作员进行包材及稀释液（若需要）的配料 Submit to ambient WH handler for packaging materials and diluents (if need) alloc
20、ation.常温库操作员AmbientWH operator参见WH018 Refer to WH0184交给冷库操作员进行半成品配货Submit to cold WH handler for SFG allocation.冷库操作员Cold WHoperator参见WH018 Refer to WH0185配完料后随货交给包装线长 submit to line leader after finished material allocation线长Line leader参见PK039 ,QA020Refer to PK039,QA0206包装批记录加页 replenish the batch
21、record submit to line leader after finished material allocation价值流协调VSC 如果生产超过正常预计天数，包装批记录需要加页。If production running time exceeds normal, some pages in BR mainly for paste sample print materials will not be enough. 在补页右上角敲包装流水号的章.Stamp pack number at top right corner on replenished page. 在补页右下角敲拷贝章.
22、 Stamp COPY at below right corner on replenished page. 将批记录第一页和补页交QA ,QA核对无误后在右下角敲”QA放行章”并交至包装部。Turn the first page of batch record and replenished page to QA for checking, then QA stamp “QA authorized” at below right corner and turn it to package department .4.3 定期数据回顾 Periodic Process Review4.3.1
23、介绍Introduction 以下内容用以确认流程的应用和其操作是符合既定目标的。责任人将对于以下定义的数据做定期的检查和报告The following paragraph is to ensure that the process is in use and works as expected. The accountable person will make regular checks and reports as defined hereunder4.3.2 详细步骤 Detailed stepsID操作步骤（什么）Action (What)谁(职责)Who(func.)控制,指标,规
24、则（QA, EHS, Fi）Controls, KPIs, Rules (QA,EHS,Fi)1.定期数据回顾Review data periodically价值流经理VS Manager 每月由价值流经理根据数据分析呈现的趋势和不良情况。下列数据每月回顾一次：A monthly review will be performed by the VS manager to detect any emerging trends or abnormal patterns in data for following KPI: S:ExcellenceKPIKPI-supply 包装计划更改率 BR c
25、hange rate2.异常汇报Handle findings 价值流经理将对突出的发现发起适当的风险操作程序或者异常情况处理程序In case findings are raised then the fill the VS manager will launch either the risk management process or the abnormality handling process as appropriate.GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Doc. No.: VS001编号：Versi
26、on No.:9.0版本号Page 9 of 9 页数Effective Date: 生效日期5. 术语GLOSSARYEPI 免费专供 Expanded Program of ImmunizationBR 包装批记录 Batch Record6. 参考文件REFERENCESQA020 包装阶段进程中的QA控制QA Controls during the Packaging OperationsWH018 生产物料的分配和递送Packaging Materials allocation and transfer to packagingPK039 包装工艺流程Packaging proces
27、s7. 附件APPENDIX7.1 包装批记录台头的相应数据源Data resource of batch record ,7.2 渗透/赠送单盒打印样张 sample of penetration/present carton8. 其他相关信息 RELATED FORMS AND TRAINING MATERIAL8.1 表格 FormsN/A8.2 培训资料Training MaterialN/A= End of procedure =包装批记录台头的相应数据源Data resource of batch recordGLAXOSMITHKLINE BIOLOGICALS (SHANGHA
28、I) LTD上海葛兰素史克生物制品有限公司Appendix：1附件Doc. No.：VS001编号Version No.：9.0版本号Page No.: 1页数 Effective Date: 生效日期Any printed copy of this document is non-controlled unless it has the blue QA Controlled stampLast saved保存时间11/10/2011 11:45 下午渗透单盒打印样张 sample of penetration carton赠送产品单盒打印样张 sample of present carton
29、GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司Appendix：2附件Doc. No.：VS001编号Version No.：9.0版本号Page No.: 1页数 Effective Date: 生效日期Any printed copy of this document is non-controlled unless it has the blue QA Controlled stampLast saved保存时间11/10/2011 11:45 下午上海葛兰素史克生物制品有限公司GlaxoSmithKline Biolo
30、gicals (Shanghai) Ltd.变更历史CHANGE HISTORY 编号: VS001Doc. No标题: 包装指令单和包装批记录的签发与批准Title: Packaging Order & Batch Record issuing and approval版本号Version No.生效日期Effective Date变更内容Description of Change变更理由(以及可能的技术变更)Justification of Change (and Technical Change No if applicable)1.020/12/20061). Add numberin
31、g principle2). Updated PO flow process1). New department VS, separated SOP from LF0102). Updating flow process 3). Add numbering principle2.009/03/20071). Deleted grouping label PO issuing2). Deleted contents related to sub-batch3). Add BR preparation, including BR index, BR replenishment4). Updated
32、 PO flow process1). No PO for grouping label2). No sub-batch3). BR preparation by VS4). Updating flow process3.022/01/20081). Adapt to new format2) Updated batch record replenishmentBatch record changed4.007/04/20081) Change the Appendix2) Change the FlowchartNew PO format5.017/03/20091.Add FRS2. ch
33、ange PO.（commercial production）format, refer to 4.1.2.1 Only SFG, diluents and printed packaging materials (carton box, leaflet, label and needle) display on the PO.3. Define that PO. Was turned from ambient WH operator to cold room operator. Refer to 4.2.2.3&4.2.2.44.Add product ID code in chapter
34、4.1.2.35.Delete grouping labels batch record preparation in chapter 4.31. Adapt to the current process2.Circulate more clearly6.031/05/20091. Delete package order issuing, the information is involved in BR and BOM.2. Add data resource of batch record3. Delete FRS modelUpdating flow process7.018/03/2
35、0101 .Delete FRS model2.Delete FG Kanban Process3.Add 4.1.2.2 delivery ID code process4.Add 4.1.2.3 detail to the package for penetration products5.Add the sample to appendix21. Adapt to the current process2. Refer to DR-20100063. Requirement from commercial team8.030/10/20101. Add the Present product on 4.1.2.32. Update the appendix13. Add the sample pic on appendix21. refer to change control: CM20101032. Adapt to the current process9.01. Add 4.1.2.1 batch qty principle & note2. Add the KPI controlRefer to CP-2011003Page 1 of 1Last saved保存时间11/10/2011 11:45 下午
