批号编制程序.doc

STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 1 页页 共共8页页 PAGE 1 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE 文件分发号 文件分发号 Distribution No 审批过程审批过程 Approval 姓名 Name职务 Title 起草人 Initiator 审阅人 Reviewer 批准人 Approver 分发表分发表 Distribution List 部门部门 Dept 分发号分发号 Distribution Number 部门部门 Dept 分发号分发号 Distribution Number 质量部01采购部03 生产部02仓库04 更改履历更改履历 Change Summary 版本号 VERSION 更改描述 DESCRIPTION OF CHANGE 01首版 STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 2 页页 共共8 页页 PAGE 2 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE 1 0目目 的的 Purpose 建立批号的编制程序 适合欧卡姿化妆品有限公司生产的所有产品 To establish batch lot numbering procedure to trace all products produced in OCUZ 2 0范范 围围 Scope 适用于欧卡姿化妆品有限公司接收的原材料 半成品 配制的中间体 灌装前溶液 灌装后的半成品以及最终成品 包括常规生产批 研制批 试验批和验证批 This SOP is applicable for received raw material and assembly component assembled process product prepared intermediate bulk solution filled semi product and final product including routine production batches RD batches PD batches and product validation batches which are routine produced in OCUZ 3 0定定 义义 Definition 3 1批 在规定限度内具有同一性质和质量并在同一连续生产周期中生产出来的 一定数量的物料 或中间体 或灌装前溶液 或其他半成品 或成品为一批 Batch A defined quantity of material or bulk intermediate or other process product or finished product that is intended or purported to be uniform in character and quality and which has been produced during a defined cycle of manufacture A batch can be also referred to as a lot 3 2批号 用于识别并追踪一批的一组数字和 或字母 Batch Number A distinctive combination of numbers and or letters which specifically identifies a batch or lot and permits its history to be traced 3 3接收的原材料 用于生产的化学原材料和包装材料 Received raw material include chemical raw material packaging material used into production and so on 3 4配制的中间体 由配料人员用原材料配制的 用于配料生产的溶液 Prepared intermediate is solution prepared by Compounding person and used for compounding of product 3 5灌装前溶液 配料完成后 开始灌装前的产品溶液 Bulk solution is product solution after compounding and just before filling 3 6灌装后的半成品 Filled semi product and final product STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 3 页页 共共8 页页 PAGE 3 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE 灌装后的半成品是指已经灌装 并 加塞 加盖 但没有完成 BOM 物料清 单 上规定的所有包装的产品 Filled semi product is the product after filling tipping and capping but has not finished all packaging processes specified on the relevant BOM Bill of Material 3 7组装半成品 Assembled semi product and final product 组装半成品指由两个或两个以上的组件组装而成的半成品 并且不能直接用 于销售 Assembled semi product is the semi product assembled with two or more components and can not go into market directly 成品是指已经完成 BOM 上规定的所有生产 包装的产品 Final product is the product that has all production packaging processes specified on the relevant BOM 3 8RD 批 指产品研发阶段的小批量试制 主要公司技术部研发的新产品 RD 批产品不能用于商业销售 RD batch means the trial production during research and development process which usually coordinated by R D department in UK corporate The product of trial batch can not be released for commercial sale 3 9PD 批 对产品进行大批量验证之前 先尝试配制 灌装 确认相关工艺参数 以确保验证批的顺利进行 试验批产品不能用于商业销售 PD batch means product development batches including trial compounding and trial filling so as to confirm the critical process parameters is performed before validation batch of new product to make sure the success of validation batch The product of trial batch can not be released for commercial sale 3 10验证批 PV 用于验证生产工艺和 或产品的生产批 验证批是否可以用于销 售应遵循总部的政策 Production Validation Batch is the manufacturing batch used for process validation and or product validation Weather the validation batch can be released for commercial sale should follow corporate policy 3 11顾客委托加工 在我公司特指对顾客提供的产品在我公司重新进行包装 且 重新包装后的产品不在中国国内销售使用 Toll Processing in AMO Hangzhou is specified as repackaging the customer supplied product which is not produced in Hangzhou plant and the repackaged product will not go to the market of Chinese mainland STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 4 页页 共共8 页页 PAGE 4 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE 4 0 责任责任 Responsibility 4 1 仓储部 采购部 生产部负责按本程序分配产品批号 Material Mfg department is responsible for assigning the batches number according to this procedure 4 2 采购部 仓储部 生产部 质量部经理有责任确保本程序的严格执行 Material Mfg QM managers are responsible for ensuring the strict execution of this procedure 4 3 质量经理或指定的人员负责本程序的修订 QM manager or designated person is responsible for updating the procedure 5 0程序 程序 Procedure 5 1 1 1 接收的原材料批号分配原则 Lot number assigning principle for received raw material 接收批号定义为 RMYYMMDDXX the receiving batch number for the others is specified as RMYYMMDDXX RM 原材料 RM Raw material YY 接收年份 YY the receiving year MM 接收当月的两位数 MM Two digits of the receiving month DD 接收当天的两位数 DD Two digits of the receiving date XX 由 01 开始 增值为 1 的接收序列号 XX Receiving sequential number beginning with 001 and incrementing by one 5 1 1 2 配料批号分配原则 Lot number assigning principle for bulk solution STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 5 页页 共共8 页页 PAGE 5 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE 批号定义为 ZMYYXXXX batch number for the others is specified as ZMYYXXXX ZM 配料和中控溶液 ZM OCUZ manufacture YY 配制年份 YY mixing year XXXX 由 01 开始 增值为 1 的接收序列号 XXXX mixing sequential number beginning with 0001 and incrementing by one 5 1 1 3 灌装批号分配原则 Lot number assigning principle for filled semi product 批号定义为 ZF140001 the filled semi product batch number for the others is specified as ZF140001 ZF 灌装的半成品 ZF filled semi product YY 年份 YY the filling year XXXX 由 01 开始 增值为 1 的灌装序列号 XXXX sequential number beginning with 001 and incrementing by one 5 1 1 4 成品批号分配原则 Lot number assigning principle for finished product 批号定义为 ZP140001 the finish product batch number for the others is specified as ZP140001 ZP 成品 ZP finish product STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 6 页页 共共8 页页 PAGE 6 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE YY 年份 YY the filling year XXXX 由 01 开始 增值为 1 的灌装序列号 XXXX sequential number beginning with 001 and incrementing by one 5 1 1 1对批号分配的特别说明 Below requirement shall also be followed for Lot number assigning 5 1 1 1 1 在同一条灌装线灌装时 由于机器故障更换灌装机 或更换配料批号时 需要更换灌装批号 Filling with the same line products are filled with same bulk solution change filling device or change ZM batch 5 1 1 1 2 在不同灌装线灌装同批灌装前溶液 则应分配不同 的灌装批号 Products are filled through different line with same bulk solution different filling lot number should be assigned 5 1 1 1 3 更换 BOM 物料清单 上标明的包装物料的品种 包括标签 纸盒 说明书 纸箱等 需要更换成品批 号 One or more out of the packaging items specified on the relevant BOM is changed such as label unit carton insert shipper and etc ZP batch should be changed 5 1 1 1 4更换 BOM 物料清单 上规定的某一种半成品 如 灌装后半成品 组装产品任一子物料的更换 的批号 Change the bottle lot number including the filled bottle and labeled bottle 5 2 2 RD 批的产品 For R D batch 5 2 2 1 R D 阶段的产品批号用 RDYYXXX 试验阶段的产品批号 用 TRYYXXX R D Step batch will be assigned with RDYYXXX product development batch will be assigned with TRYYXXX RD R D 阶段 TR 产品试验批阶段 STANDARD OPERATING PROCEDURE 标准操作程序标准操作程序 文件编号 文件编号 SOP 20 001 DOCUMENTDOCUMENT NO NO 版本号 版本号 01 VERVERSION SION 第第 7 页页 共共8 页页 PAGE 7 OF 8 标题 批号的编制程序标题 批号的编制程序 TITLE TITLE BATCH LOT NUMBERING PROCEDURE RD R D Step batch TR Trial run step batch Y 年份两位数 Y XXX 由 001 开始 增值为 1 的序列号 XXX Sequential number beginning with 001 and incrementing by one 5 2 2 2 批号分配原则按 5 1 3 条执行 Assignment of batch number follow item 5 1 3 5 2灌装后产品有效期的规定 Expired date assignment for filling product 5 2 1灌装后产品的有效期按相关产品的稳定性监控结果确定 The expired date for the filled product shall be assigned according to the product stability study 5 2 2对于组装产品 组装后的外包装上的有效期应为各组装组件的最近有 效期 For assembled finished product the expired date on unit carton shall be the shortest expired