PD-M7.5.0-005 V02 生产物料配送管理制度

1、生产物料配送管理制度 本文件为受控文件，仅供成都蓉生药业有限责任公司版权所有，严禁任何无效授权使用、泄露或复印，违者必究。This document is subject to copyright and is confidential. This document has been prepared solely for the use of Chengdu Rongsheng Pharmaceuticals Co., Ltd. Any unauthorized use or disclosure or copying is strictly prohibited.职/岗位Position姓

2、名Name签名Signature日期Date起草人Originated byPD生产技术岗周于胜/2011.09.05修订人Revised byPD物料配送管理李 凯起草/修订部门审核人Dept. Reviewed byPD副经理秦东升主审部门审核人Major Dept. Reviewed byPD经理吕家成批准人Approved byQA经理刘素芳HR培训确认Training Confirmed byHR经理梅 凌生效日期Effective Date发至部门Distribution副本编号Copy No1 目的和范围Objective & Scope1.1 目的Objective：为规范生产

3、过程的物料管理工作，制定本文件。 This document is established to regulate the management of materials in production process.1.2 范围Scope：本程序适用于生产过程中的物料的配送管理。This procedure is applicable to distribution management in production process.2 定义和缩写Definitions &Abbreviation2.1 生产物料：指与分离室、制剂室生产过程相关的原辅材料。 Production material

4、s: refers to the raw materials and excipient related to production processes of SW and FW.3 职责Responsibility3.1 仓储部负责生产物料的发放和清洁预处理。The storage department is responsible for the distribution of production materials and basic clearance.3.2 物料配送中心负责生产物料准备、再处理、称量（计数）、管理及发放。 The distribution area is resp

5、onsible for preparation, clearance, weighing (counting), management and distribution of production materials.3.3 生产部门负责及时配合接收生产物料并做好暂存工作。 The productive departments are responsible for receiving production materials duly and temporary storage.3.4 质量保证部负责生产物料配送工作的监督检查。 The QA is responsible for the s

6、upervision and inspection of distribution of production materials.4 健康、安全与环境Health, Safety & Environmental 不适用N/A5 内容Contents5.1 建立物料动态卡（明细帐）。Set up the material dynamic card (subsidiary ledger).5.2 配送人员接收由仓储部将脱去外包装的物料后，应对物料表面清洁消毒，及时入账、储存，并做好标示管理。The outer packages of materials should be taken off i

7、n storage department firstly and then distributed to distribution area. The distribution personnel should clean and disinfect the surface of materials after the receipt, then record the information in corresponding dynamic cards, store and mark the materials well.5.3 物料接受原则：先领取不易产尘的物料，再接受易产尘的物料。Mate

8、rials receiving principles: receive materials which are more difficult to produce dust at first, then receive materials which are easier to produce dust.5.4 物料发放原则：先进先出，零头先出。Materials distributing principles: first-in first- out, remnant first out.5.5 物料称量配送区分为两处：The materials distribution area is d

9、ivided into two parts.5.5.1 位于C区一层的配送区负责助滤剂、制品瓶、胶塞、铝塑盖、滤芯、滤袋、滤板的配送，并负责转运生产部门所需的低耗物料。该配送区带有滤料分量间CF105，带有除尘净化系统用于称量助滤剂。Distribution area in floor1 of C area are responsible for the distribution of filter aid , product bottles, rubber plugs, aluminum plastic covers, filter bags ,filter boards and also

10、responsible for transporting materials of low consumption. The Room CF105 with dust extraction system is used for weighing filter aid.5.5.2 位于B区二层的配送区负责Buffer区配制缓冲液和平衡液所需的物料、一楼车间使用的麦芽糖、辛酸钠、甘氨酸、氯化钠的称量及配送，该配送区的BB209房间带有除尘净化系统用于固体称量，BB219房间用于量取液体物料，此房内配有生物安全柜用于量取强酸液体。Distribution area in floor 2 of B a

11、rea is responsible for preparing materials of buffer, balanced fluid for Buffer, and the weighing and distribution of maltose, sodium caprylate, glycine, sodium chloride for FW in floor 1. The dust extraction system in Room BB209 is used for weighing solid materials and the HR40-IIA2 biosafety cabin

12、et is used for measuring strong acid materials in order to avoid respiratory tract or equipment damage by the gas volatilized from strong acid.5.6 生产管理部在下达的生产指令时，应包括，缓冲液/平衡液配制生产指令，辅料配送生产指令、普通生产物料配送生产指令、明确每日配送物料及配送量。The production instruction made by PD should include: the preparation of buffer or ba

13、lanced liquid, the distribution of excipient, the distribution of ordinary materials. The materials and the amount of materials for distribution should be explicit.5.7 物料配送工作人员应根据所接收的生产指令，及时做好生产物料配送工作准备。The distribution personnel should complete the preparation of productive materials after receivin

14、g the production instruction duly.5.8 按所接收的生产指令要求，称量、计数物料并进行复核，操作与复核要求：Weighing, counting materials and checking followed the production instruction. The demands of operation and checking:5.8.1 为了避免发生污染、混淆和差错，称量、计数发放工作台面禁止同时存放两种及以上生产物料，尤其是相似物料。To avoid the contamination, confusion and error，it is pr

15、ohibited that two or more kinds of materials，especially similar materials on the weighing desk at the same time .5.8.2 操作人与复核人不得为同一人。The operator and checker should be independent from each other.5.8.3 操作过程应有前清场和后清场。The pre-clearance and clearance after operation should be performed in operation pro

16、cess.5.8.4 操作过程应有记录，清场内容包含在记录中。There should be record in operation process and the clearance should be included in record.5.9 物料分量完毕，剩余部分应封口保存，并贴物料开封签返还暂存间。标签样式见物料配送中心使用标签。物料开封签内容应有：物料名称、物料批号、放行单号、剩余数量、开封日期、物料有效期至、开封有效期至、操作人、复核人。The materials after completion of weighing or counting should be sealed

17、 for storage and paste materials opening labels, the style of which is in according toLabels used in materials distribution area, and returned to temporary room . The content of materials opening label should include the information of the material: name, Lot number, released number, remaining amoun

18、t, opening date, expiry date, expiry date of opening, operator and checker.5.10 根据相应的生产指令将准备好的生产物料按照所投入使用的配制批号或配送地点归类集中存放，并在每件所配送的物料上贴物料配送签。标签样式见物料配送中心使用标签 。配送签内容应有：物料名称、物料批号、放行单号、数量、用途、配送地点、操作人、复核人、配送日期。The materials prepared on the basis of production instruction should be centrally stored accordi

19、ng to the batch for preparing and location for distributing. Paste material distributing label on every piece of materials for distributing. The style of the label refers toLabels used in materials distribution area. The content of materials distributing label should include the information of material: name, Lot number, released number, amount, use, distributing location, operator, checker, distributing date.5.11 辅料应用药品包装袋双层包装转运（便于在进入使用点前脱外层包装袋），准备好的生产物料应按配送区域集中存放。Excipient should be packaged with double-deck medicine packing bags for taking off the outer