葛兰素史克 质量管理体系

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. 2. 3. 4.

目的 OBJECTIVE ...................................................................................................................... 2 范围 SCOPE ............................................................................................................................. 2 职责 RESPONSIBILITIES ......................................................................................................... 2 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 术语 GLOSSARY .................................................................................................................... 13 参考文件 REFERENCES ........................................................................................................ 13 附件 APPENDIX ...................................................................................................................... 13 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

5. 6. 7. 8.

Any printed copy of this document is none-controlled unless it has the blue QA Controlled stamp.

1. 目的 OBJECTIVE

2. 范围 SCOPE

3. 职责 RESPONSIBILITIES

Any printed copy of this document is none-controlled unless it has the blue QA Controlled stamp.

4. 步骤 PROCEDURE

4.0 流程图 Flowchart

Any printed copy of this document is none-controlled unless it has the blue QA Controlled stamp.

4.1 质量管理体系 Quality Management System

4.1.1. 介绍Introduction:

上海葛兰素史克的质量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, 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

4.1.2. 详细步骤 Detailed step

4.2 优良药品生产管理规范 Good Manufacturing Practice

4.2.1. 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 Management 4.2.1.2 人员 Personnel

4.2.1.3 文件和数据 Documentation & Data 4.2.1.4 设施 Facilities

4.2.1.5 物料与产品控制 Material and Product Control 4.2.1.6 过程保证 Process Assurance 4.2.1.7 分析控制 Analytical Controls 4.2.1.8 事件管理 Incident Management

所有有关的文件可以参考S:\SOP\Controlled Documents。

All those information could reference 4.2.2. 详细步骤 Detailed steps: N/A

4.3 管理原则 Management Principle

4.3.1. 介绍Introduction

六大管理原则是质量管理体系中必不可少的部分：

Six Management Principles are essential to Quality Management System

计划 Planning 组织 Organizing

沟通 Communicating 监测 Measuring 回顾 Reviewing 提高 Improving

4.3.1.1 计划 Planning

计划是保证质量完全地被融入到公司组织战略，运营计划和商业流程中。上海工厂的计划有以下几种：

Planning is to ensure quality is full integrated into the organization’s strategic and operational planning and business processes. The plans in GSKBS are as follows:

上海工厂战略GSKBS Alignment Grid 质量计划Quality Plan

风险管理（风险降低计划）Risk Management (mitigation plan) 验证主计划Validation Master Plan 培训计划Training Plan

审计计划（自检和内审）Audit Plan (Self Inspection & Internal Audit Plan) 供应商和分销商审计计划Supplier and Distributor Audit Plan

预防性维修和校验计划Preventive Maintenance & Calibration Plan

通过这些计划，将质量的目标和目的贯穿到整个组织机构中

Through those plans, ensure quality goals and objectives are cascaded down throughout the organization.

4.3.1.2

组织 Organizing

组织通过提供必要财力，物力和人力来保证及时的按照有关质量要求的完成商业和运营计划

Organizing is to provide required financial, material and human resources to ensure complete and timely delivery of the business plan and operational compliance with all relevant quality requirements.

上海工厂的质量部是独立的部门，以确保其可以独立及客观地行使质量控制职责。参见工厂 的组织结构图，该组织结构图应该是实时更新的，且至少每年回顾一次。

The Quality Department is independent in GSKBS. The organizational structure must allow the local quality organization to have the necessary independence and objectivity in the performance of its quality responsibilities. Refer to Site Organization Chart. This Organization Chart should be up to date, and should be reviewed at least once a year.

质量和GMP的职责个人职责描述和个人发展计划中定义了。

The responsibilities for implementing and maintaining quality and GMP are well defined in individual job description and Personnel Development Plan.

4.3.1.3

沟通 Communicating

有效的沟通能促进质量意识的提高，并且鼓励和取得每个人员在质量上的承诺

Effective communication is essential to promote awareness of quality and to encourage and secure the commitment of everyone to quality

当前工厂的沟通机制有以下几种

The current communication mechanisms in GSKBS are

-工厂质量部与其他部门的沟通

-工厂质量部与Biological全球质量部的沟通

-Communication between GSKBS QA and Biological Global Quality Function:

-工厂质量部与供应商/分销商的沟通

-Communication between GSKBS QA and Supplier/Distributor:

-工厂质量部与客户/官方机构的沟通

-Communication between GSKBS QA and Customer/Regulatory:

4.3.1.4 监测 Measuring

监测是为了监控质量情况的结果，过失和错误

Measuring is to monitor quality results, defects and errors.

工厂的监测有

Measures in GSKBS are: -重要的绩效指标 KPIs

-异常事件调查和处理Incident Investigation and Handling -部门自检 Self-inspection

利用监测去确定需要改进的方面 Use the measures to identify areas for improvement.

4.3.1.5 回顾 Reviewing

回顾是为了提高每个员工的质量意识，并维持质量在商业上的贡献

Reviewing is to raise and sustain the quality awareness to everyone and the quality contribution to the business

4.3.1.5.1回顾日常质量活动的状态

Review routine quality activities implementation status. -偏差/备注 Deviations/ Remarks -变更管理 Change Management -投诉 Complaint -验证 Validation

4.3.1.5.2回顾KPI的趋势

Review trend of KPI 例如：For example: -一次就做对 RFT

-QMS文件”in use”百分比 QMS “in use” %

-投诉支数比例和回复时间 Complaints doses rate & response time -过期的CAPA状态 Overdue CAPA status -校验周期符合性 Calibration adherence

4.3.1.5.3回顾计划执行情况

Review plan implementation status

-质量计划Quality Plan

-验证主计划Validation Master Plan -供应商全方位绩效评估Supplier TPM

-质量管理体系差距分析 QMS Gap Analysis -培训充分性回顾Training Sufficiency Review

4.3.1.5.4周期性生产回顾

Periodic Production Review

每年一次，通常在第一季度完成，以下内容应被回顾：

Once per year, normally done in the 1 quarter of the year, the content listed below must be reviewed.

st

-列出所有需要回顾的产品批次Listing of all batches included in the review -生产记录趋势（包括产量和中间控制）

Production records trends (including yield or output, and in-process control)

-实验室记录趋势，超标分析Laboratory release testing record trends, OOS -稳定性记录趋势Stability testing records trends,

-产品和物料质量标准和测试方法Product and material specifications and test methods -留样检查Retention Sample Check -报废，返工，再包装和再加工

Rejected, reworked, repack and reprocess batches of product and material -偏差Deviation

-相关法规文件，药典，其他市场要求，内部标准文件，技术协议和TTS的最新符合性

Conformance to up to date and relevant registration, pharmacopoeia, and other market requirement, internal standard documents, Technical agreements and TTS

-新的注册申请，再回顾期间申报的，批准的或拒绝的申报资料包括入市后的承诺

New Regulatory applications and any variations to registered details submitted, granted or refused during the review period and including any post marketing commitments

-变更控制Change Control -验证状态Validation Status

-投诉趋势，召回和退货 Complaint trends, Recalls and Returned goods. -关键设备和公用设施的性能

Critical Equipment and utilities performance, Exceeded action limits. -供应商表现Supplier Performance

4.3.1.5.5以上所有的内容通过以下形式被回顾

All above items will be reviewed by:

-质量管理会议Quality Council Meeting -内部审计Internal Audit

-验证回顾报告Validation Review Report -周期性生产回顾（格式参见GQG5008）

Periodic Production Review (refer to GQG 5008 for PPR template )

QMS执行的有效性必须通过自检和监控审计（L2及L3审计）进行评估。 The on-going effectiveness of QMS implementation must be assessed through self

inspection and monitoring audits (L2 and L3 audit) where performed.

4.3.1.5.6 工厂质量管理会议的目的The purpose of Site Quality Council Meeting

按照Annex 1的章程逐项进行回顾，跟踪上次会议的行动，通报当月值得关注的质量相关事

件，确定需采取的行动计划及其责任人、完成时间。对于Part7, 8 - Validation, Calibration，应通报相关偏差，并确保预防纠正措施恰当有效。

The council is conducted following the charter in Annex1, including the follow up of Last council, communicate the outstanding issues subjected to quality management, and then

confirm the action plan with its owner & due date. For Part7, 8 - Validation &Calibration, the relative deviation must be discussed to ensure the CAPA effectiveness.

4.3.1.5.7 QMS执行的有效性必须通过自检和监控审计(L2内审及L3 Corporate审计)进行评估。 The on-going effectiveness of QMS implementation must be assessed through self Inspection and monitoring audits (L2 Internal audit and L3 Corporate audit) where

performed.

4.3.1.6 提高 Improving

提高是为了预防质量事故的发生，最终达到卓越

Improving is to prevent the quality problem and issue, ultimately deliver industrial Excellence.

在上海工厂，持续改进的建议通常来源于

In GSKBS, the recommendations for the continuous improvement is usually derived from:

-风险管理流程 Risk management process -变更管理系统Change Management system -质量管理会议Quality Council

-周期性生产回顾 Periodic Production Review -验证回顾报告Validation Review Report -偏差处理Deviation Handing

持续改进的进度通过以下流程来跟踪和回顾：

The progress of the actions is followed and reviewed by:

-纠正预防措施系统Corrective action and preventive action system

4.3.2. GSKBS根据国家食品药品监督管理局《关于推动药品生产企业实施药品质量受权人制度的通

知》（国食药监安〔2009〕121号），及沪药监安〔2009〕495号的要求，执行药品质量受权人制度。由质量保证部经理作为GSKBS质量受权人，经企业法人代表授权批准，并提交上海食品药品监督管理局备案批准。 According to the notice from SFDA（国食药监安〔2009〕121号），and SHFDA沪药监安〔2009〕495号, GSKBS execute the system of “Qualified Person”. Manager of quality assurance department is assigned to be QP of GSKBS. He/she is authorized by Corporate Representative, and is registered in SHFDA.

4.3.2.1质量受权人按规定行使以下职责：The main responsibility of QP is as below

-负责保证企业质量管理体系的有效运行

Ensure the effectiveness of quality management system -负责对影响产品质量的关键管理活动行使决定权

Final approval for key documentations which could affect product quality -对于产品质量有重大影响的情况行使否决权 Own the veto right of key proceedings -参与或负责与药品质量相关的其他工作

Participate or response for the works related to product quality -负责与药品监督管理部门的沟通

Responsible for the communication with Food and Drug Administration.

具体职责参见相关法规文件。Detailed responsibility refer to relevant regulations.

4.3.2.2 因工作需要，药品质量受权人可将质量管理的部分具体工作转授权给转受权人，但药品质量受 权人必须对转授权的这部分质量管理工作负责（即授权不授责）。转受权人具有相应专业技术 资格和工作经验与转授工作内容相适应的，其培训由药品质量受权人负责组织。转受权人不得 再次转授权其他人承担相关工作。

To adapt routine work, QP could assign some rights to a deputy. However, QP is the responsible person for these authorizations. The deputy should have suitable certification and experience of relevant warrant. The training for a deputy is organized by QP. The deputy can not assign his/her commission to other people.

5. 术语 GLOSSARY

GSKBS: GLAXOSMITHKLINE BIOLOGICALS SHANGHAI LTD.

上海葛兰素史克生物制品有限公司

6. 参考文件 REFERENCES

GQMP 1001/1003/5008/5010 GQP 1101/2101/5302 GQG 5008

GSOP 9000004352

7. 附件 APPENDIX

Appendix 1 GSKBS Site Quality Council Meeting Charter

Appendix 2 Biological Shanghai Quality Council Communication

8. 其他相关信息 RELATED FORMS AND TRAINING MATERIAL

8.1 表格 Forms

QA004-F1 QMS Gap Analysis Form

8.2 培训资料Training Material

N/A

===== End of procedure =====

GSKBS Site Council Meeting Charter

Biologicals Shanghai Quality Council Communication

Date:

Author:

Date/Month/Year QA/RA Manager

CHANGE HISTORY

CHANGE HISTORY

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