文件印制、分发、保管、收回、销毁、撤销作业指导.docVIP

文件题目 Document Title 文件印、发放、保管、收回、销毁SOP SOP - Printing, delivery, filing, recalling and destruction of documents 编 Document Code 文件版本号 Version Code 00 (2011) 文件种类 Category of Document 管理类 Management 发放部门 Department of Issue QA 人员 Person 类别 Category 姓名/职 Name /Position 签名 Signature 日期 Date 编写人 by 审核人 Check by 批准人 Approved by 生效日期 Valid from 文件分发部门： Department of document distributed: 序号 Serial No. 部门 Department Name 房间号 Room No. 负责人 Manager 1 2 3 4 5 6 7 8 9 10 文件变更历史： History of document changing: 版本 Version Code 变更日期 Changing Date 变更内容摘要 Abstract of Changing Contents 00 (2011) 2011.05.16 建立文件 File foundation  1. SOP的目的 Aim 建立GMP文件的复制、分发、保管、收回、销毁、撤销程序，使文件保管和使用规范化。 The purpose of this SOP is to define an appropriate procedure for the printing, delivery, keeping, recalling, destruction and revocation of documents, in order to standardize keeping and using of documents. 2. 范围 Scope 所有GMP文件的复制、分发、保管、收回、销毁、撤销管理过程。 The SOP must be applied to the printing, delivery, keeping, recalling, destruction and revocation of all the GMP-related documents at Huiyu. 3. SOP的内容 Content of Standard Operating Procedure 3.1 复印/分发/收回 Printing/delivery/recalling 公司GMP文件由QA部进行管理，任何部门不得私自复印。若发生以下情况需要使用文件的复印件，须由使用部门填写《文件复印申请表》（见附录1）向QA部提出申请，由QA负责人批准，交付文件管理QA进行复印、分发。 GMP documents are managed by QA department, and no another department shall copy without permission. In case of the following condition to copy the documents, the use department s apply to QA department by filling out the Application for Document Copy (see Annex 1). After approving by the head of QA, the application should be delivered to document manage QA for document copying and distribution. 3.1.1 新编文件复印、分发 Copying and distribution of new documents 新编文件生效后，由文件管理QA根据根据文件首页所示的发放部门确定需复印的份数，并亲自负责复印。复印件应能清晰可辨，复印过程中作废的文件应即时销毁。复印结束后必需在原件及复印文件的每一页上加印“GMP批准文件”。 Document manage QA must define how many copies has to be printed off according to the nu