质量管理体系文件
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DOC. NO.: QA004
编号：
STANDARD OPERATION PROCEDURE
标准操作程序 Version No.:
版本号
质量管理体系
Quality Management System Superseded Date:
替代版本日期
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Last saved保存时间 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:
1. 目的 OBJECTIVE ...................................................................................................................... 2
2. 范围 SCOPE ............................................................................................................................. 2
3. 职责 RESPONSIBILITIES ......................................................................................................... 2
4. 步骤 PROCEDURE ................................................................................................................... 3
4.0 流程图 Flowchart ........................................................................................................... 3
4.1 质量管理体系 Quality Management System .................................................................... 4
4.2 优良药品生产管理规范 Good Manufacturing Practice...................................................... 5
4.3 管理原则 Management Principle ..................................................................................... 6
5. 术语 GLOSSARY .................................................................................................................... 13
6. 参考文件 REFERENCES ........................................................................................................ 13
7. 附件 APPENDIX ...................................................................................................................... 13
8. 其他相关信息 RELATED FORMS AND TRAINING MATERIAL ............................................... 13
8.1 表格 Forms ................................................................................................................... 13
8.2 培训资料Training Material ............................................................................................. 13
GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司
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Last saved保存时间 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 integrate the management principle
with Good Manufacturing Practice requirement so as to
deliver the quality for the customers, compliance 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生物制品有限公司内所有与质量有关的操作 This procedure applies to all activities related quality
throughout GSKBS
3. 职责 RESPONSIBILITIES
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管理层负责检查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
详细职责参加第四章 3.1 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.
3.2 It is the responsibility of QMS Champion to manage
local QMS implementation process.
3.3 It is the responsibility of the quality dept. to establish,
maintain and improve the quality management system. To
ensure quality/compliance risks arising from implementation
are appropriately managed
3.4 It is the responsibility of all staff to follow the quality
management system
3.5 It is the responsibility of management team to review
the implementation of quality management system, and
provide the related resource for its improvement.
Refer to chapter 4 for detailed responsibilities
GLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD上海葛兰素史克生物制品有限公司
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Last saved保存时间 4. 步骤 PROCEDURE
4.1 流程图 Flowchart
4.1 QMS
质量管理体系 4.2.1.8. Incident
Management
事件管理
4.3.1.6
Improve提高
4.3.1.3
Communicate沟通
