批号编制程序.docVIP

文件分发号：__________ Distribution No. 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 Distribution List 部门 Dept. 分发号 Distribution Number 部门 Dept. 分发号 Distribution Number 质量部 01 采购部 03 生产部 02 仓库 04 更改履历Change Summary 版本号 VERSION 更改描述 DESCRIPTION OF CHANGE 01 首版 目 的:Purpose: 建立批号的编制程序，有限公司生产的所有产品。To establish batch/lot numbering procedure to trace all products produced in OCUZ 范 围 :Scope: 适用于化妆品有限公司接收的原材料配制的中间体、灌装前溶液、灌装后的半成品成品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. 定 义：Definition: 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. 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. 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. 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. 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. 灌装后的半成品：Filled semi-product and final product 灌装后的半成品是指已经灌装，并（加塞）加盖，但没有完成（）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). 组装半成品：Assembled semi-prod