葛兰素史克质量管理体系.docxVIP

总页数：15页(13页+2个附件：2页) Total pages: 15 pages (13 pages + 2 appendices : 2 pages) 目录 TABLE OF CONTENTS: TOC \o 1-5 \h \z \o Current Document 目的 OBJECTIVE 2 \o Current Document 范围 SCOPE 2 \o Current Document 职责 RESPONSIBILITIES 2 \o Current Document 步骤 PROCEDURE 3 4.0 流程图 Flowchart 3 质量管理体系 Quality Management System 4 优良药品生产管理规范Good Manufacturing Practice 5 管理原贝ij Management Principle 6 \o Current Document 术语 GLOSSARY 13 \o Current Document 参考文件 REFERENCES 13 \o Current Document 附件 APPENDIX 13 \o Current Document 其他相关信息 RELATED FORMS AND TRAINING MATERIAL 13 表格 Forms 13 培训资$4Training Material 13 Doc. No.: QA004 Version No.: 7.0 Page 2 of 13 Effective Date: 编号： 版本号 页数 生效日期 1.目的 OBJECTIVE 建立一个结合管理原则和GMP要求的质量管理体 系，从而为客户提供好的产品质量，符合法规的要求 并促使上海葛兰素史克有限公司持续不断的进步。 To establish system to in teg rate the manageme nt principle with Good Manufacturing Practice requirement so as to deliver the quality for the customers, complianee for the regulators and continuous improvement for the GSKBS? 2.范围 SCOPE 此程序适用上海葛兰素史克牛物制甜有限公司内 This procedure applies to all activities related quality 所有与质量有关的操作 throughout GSKBS 3.职责 RESPONSIBILITIES 3.1工厂经理应 3.1工厂经理应 ?保证足够的资源以建立、执行及维护工厂的质量 体系 ■指定并授权QMS倡导者负责将QMS的要求有效 地融入工厂质量体系 ■保证各部门经理在他们管理的区域执行QMS 3.2 QMS倡导者负责管理工厂QMS执行的过程 3.3质量部负责建立，维护以及改进质量管理体系。 确保QMS执行过程中产生的质量/符合性风险能 够很好地被管理 3.4所有员工必须遵守质量管理体系。 3.5管理层负责检杏回顾质量管理体系的执行情 况，并对改进质量体系提供相应的资源 It is the responsibility of site manager to -Ensure resources are made available to establish, implement and maintain the local quality system? -Assign and empower a QMS Champion to take responsibility for effective integration of QMS requirements into the local system. -Ensure department managers implement QMS within their area of accountability? It is the resp on sibility of QMS Champi on to man age local QMS implementation process? It is the responsibility of the quality dept, to establish, maintain and improve the quality management system? To ensure quality/complianee risks arising from implementation