某外企质量管理体系文件.docx

1、某外企质量管理体系文件总页数: 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 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xxxx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

2、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xxx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 GSKBS3.职责 RESPONSIBILITIES3.1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

3、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QMS3.2 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 l

4、ocal 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 implementat

5、ion 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 managed3.4 It is the responsibility of all staff to follow the quality management system3.5

6、 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 responsibilities4.步骤 PROCEDURE4.1流程图 Flowchart 4.2质量管理体系 Quality Management System4.2.1. 介绍Introduction: xxx的质量

7、体系是一个具有生命力的系统,全面的政策,支持的过程和与法规要求一致的程序,并在公司内部进行积极的管理Quality Management system is a living system with comprehensive policies, supported by process and procedure aligned to regulatory requirement and requiring active management in GSKBS该体系的输入为: Input of this system-Global Requirements (including GQPs,

8、GQMPs, GSOPs, Global Quality Council Communication and Global Quality Alert) 全球要求（包括GQPs, GQMPs, GSOPs, 全球质量管理会议沟通和质量警报）-Continuous Improvement based on process基于过程的持续改进-Regulatory Requirements 法规政策4.2.2. 详细步骤 Detailed stepID操作步骤（什么）Action (What)谁(职责）Who(func.)控制,指标,规则（QA, EHS, Fi）Controls, KPIs, Ru

9、les (QA,EHS,Fi)1.监控体系3个输入的变化Monitor change of 3 input of QMS 质量经理Quality Mgr.N/A2.组织差距分析Organize gap analysis.QMS倡导者QMS ChampionQMS差距分析表的编号为GA-年份-序列号，序列号从001开始The No. of QMS gap analysis form is GA-Year-Serial No., starting from 001.根据全球QMS的变更情况，填写QA004-F1的A部分后交相关指定人员。Whenever there is any change of

10、 global QMS, fill in part A of QA004-F1, and then handover this form to the assigned person.3.执行差距分析Perform gap analysis SOP作者或指定人员SOP author or assigned person分析前，需要从My-Learning上取得证书，然后完成QA004-F1的B部分。Before gap analysis, the person must acquire the certificate via my-learning. Complete the Part B o

11、f QA004-F1.4.对差距执行风险评估并确认行动计划Perform risk assessment of the gap and confirm the action plan执行差距分析人员与相关部门经理Related person and Dept. Mgr. who performed gap analysis参见QA053，并填写QA004-F1的C部分。Refer to QA053, fill in part C of QA004-F1.对于风险评估认为对产品安全、质量或有效性没有影响者，应作为“差异”进行记录，可以不再采取进一步行动。For the differences a

12、ssessed as having no impact on product safety, quality or efficacy, it should be recorded as a difference. No further action is required.对于风险评估认为可能对产品安全、质量或有效性有影响者，则应作为“差距”，必须采取进一步行动消除差距，降低风险。参见QA053和QA052。For the differences assessed as having potential impact on product safety, quality or efficacy

13、, it should be considered as a gap. Further action must be taken to mitigate the gap and risk. Refer to QA053 & QA052.行动计划必须在四个月内制定并完成（QMS文件预放行阶段一个月，生效后三个月，共计四个月）The action planning must be scheduled and completed with 4 months. (QMS documentation pre-release one month, 3 months after being effectiv

14、e, 4 months in total).5.监控计划执行的过程Monitor the progress of action planningSOP作者或指定人员SOP author or assigned person填写QA004-F1的D部分，并通知QMS倡导者。Fill in the Part D of QA004-F1，and then inform QMS Champion.6.确认差距已经消除Confirm Gap is closedQMS倡导者QMS Champion填写QA004-F1的E部分Fill in the Part E of QA004-F17.回顾和提高质量管理

15、体系执行Review and Improve the Implementation of QMS.管理层Management Team-审计（自检，内审和全球审计）Audit (self-inspection, internal and global audit)-定期回顾 Periodic Review4.3优良药品生产管理规范 Good Manufacturing Practice4.3.1. 介绍Introduction优良药品生产管理规范是药品生产的最低要求,也是确定我们做正确的事,并正确地做事的过程.Good Manufacturing Practice is the regulatory requirement for drug manufacturing, and a process to ensuring that we do right things, and do things right.从八个方面进行介绍 Introduce GMP from eight sections:4.2.1.1 管理 Management4.2.1.2 人员 Personnel4.2.1.3 文件和数据 Documentation & Data4.2.1.4 设施