质量体系--有效质量管理体系的关键--奥星公司验证总监2011.10上海ISPE(共64页).doc
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1、精选优质文档-倾情为你奉上ISPE-CCPIE CHINA CONFERENCE 2011 Quality System Key to the effective Quality Management System 质量体系有效质量管理体系的关键 Anwarul Haque, Validation Director, Austar 奥星公司验证总监 ISPE October 25-28 2011 Shanghai 1 Regulatory Perspective 法规问题 The holder of a Manufacturing Authorisation (MA) must manufac
2、ture medicinal products ensuring that: 生产许可证(MA)的持有人所生产的药品必须保证: Fit for their intended use符合预期用途 comply with the requirements of the MA符合MA中的要求 Do not place patients at risk due to inadequate safety, quality or efficacy.不会因安全性、质量或功效不当而对患者造成风险 Senior Management holds the responsibility for Quality ob
3、jective (stated above) 高级管理层担负着质量目标的责任(如上所述) In attaining the objectives it requires participation and commitment by all stake holders to the company 在达到目标方面要求公司内的所有利益相关方的参与和承 诺 ISPE-CCPIE CHINA CONFERENCE 2011 Regulatory Perspective Contd 法规问题-续 To achieve the quality objective reliably there must
4、be a comprehensively designed and correctly implemented system of QA incorporating GMP 为可靠地达到质量目标,必须有经过综合设计和正 确实施且集成了GMP的质量保障系统。 Quality objectives fully documented and its effectiveness monitored 质量目标应有完整的文件记录并对其有效性进行监 控。 All parts of the Quality Assurance system should be adequately resourced 质量保证
5、系统的所有部分均应配备有充分的资源。 ISPE-CCPIE CHINA CONFERENCE 2011 Regulatory Findings 监管检查问题 Zhang Aiping (Director of Center for Certification of Drug, SFDA) 国家食品药品监督管理局药品认证管理中心主任张爱萍: “ We found that the defects are concentrated in the effectiveness of such quality systems as the QC system and the QA system. The
6、 problems are mainly in insufficient understanding, inaccurate grasping and the inexperience in using the elements of the quality assurance system. Especially that there are such problems as insufficiently established procedures or failures in completing corresponding activities as required in the e
7、stablished procedures in such areas as change control, deviation handling and corrective and preventive actions (CAPA). They are inflexible in implementing such new concepts as trend analysis, alert limits, action limits, annual product quality review, etc. . They are still at an early stage in the
8、use of quality risk management and they are not fully combined with their own experiences or the actual production situations. These defects have reflected that the enterprises have not integrated GMP concepts into each of the steps of their quality system management activities and product quality r
9、isk management has not been effectively implemented.” 张爱萍:我们对已进行现场检查的企业和进行模拟检查的企业做了分析对比发现,缺陷比较 集中地体现在质量控制与质量保证等质量体系有效性方面,问题突出体现在对质量保证体系 构成要素理解不清楚,把握不准确,使用不熟练等。特别是对变更控制、偏差处理、纠正和 预防措施(CAPA)方面,存在程序制定不够完善,或者未按照制定的程序要求完成相应工作 的情况;对于趋势分析、警戒线、纠偏线、年度产品质量回顾分析等新概念的应用较为机械 ,存在生搬硬套的情况,没有与自己实际情况结合起来;对于质量风险管理的使用尚处于
10、初 期,没有完全与自己已有的经验以及产品或生产的实际情况结合。这些缺陷反映出目前企业 尚未完全将药品GMP的精髓有机地融入到其质量体系管理的各个环节中,产品质量的风险 管理还未得到有效贯彻。 ISPE-CCPIE CHINA CONFERENCE 2011 Quality Management System 质量管理系统 QMS A quality management system (QMS) is an organizational structure implemented by a company and consists of procedures, processes and re
11、sources used for quality management. QMS is designed to increase performance and quality within an organization 质量管理系统(QMS)是公司为进行质量管理而实施的一种组织结构 ,包括规程、工艺和资源。 QMS设计用于提高组织内部的业绩和质 量。 Purpose目的 A QMS is implemented to promote quality and efficiency within a company. QMSs rely on creating procedures for t
12、he processes used in producing a product or service. QMS的实施目的是为了提高公司内部的质量和效率。 QMS依赖于为 用于生产产品或提供服务的工艺流程制定相应规程。 ISPE-CCPIE CHINA CONFERENCE 2011 Product Lifecycle 产品生命周期 There are 4 phases of product lifecycle: 产品生命周期有4个阶段: Pharmaceutical Development制药研发 Technology Transfer技术转移 Commercial Manufacturin
13、g商业化生产 Product Discontinuation产品停产 For each of the above phases the QMS needs to be appropriate for that phase 需针对上述每个阶段制定适宜的规定 QMS ISPE-CCPIE CHINA CONFERENCE 2011 Quality Risk Management 质量风险管理 Quality risk management is integral to an effective QMS 质量风险管理是有效QMS中不可分 割的一部分。 It provides a proactive
14、approach 它提供了一种积极主动的方法 It facilitates continual improvement of process performance and product quality throughout the product lifecycle. 它有助于在产品的整个生命周期过 程中对工艺性能和产品质量进行持 续改进。 ISPE-CCPIE CHINA CONFERENCE 2011 The Objectives of QMS QMS的目的 Achieve Product Realisation 实现产品生产 Establish and Maintain a Stat
15、e of Control 建立并维持受控状态 Facilitate Continual Improvement 帮助进行持续改进 ISPE-CCPIE CHINA CONFERENCE 2011 The Objectives of QMS QMS的目的 实现 Achieve Product Realisation 产品生产It should allow the delivery of products with the quality attributes appropriate to meet the needs of: 应使得可以生产出符合如下方面要 求的质量属性的产品: - patien
16、ts 患者要求 - health care professionals医疗保健 专业人员的要求 - regulatory authorities法规当局的 要求 - internal and external customers内 部及外部客户的要求 ISPE-CCPIE CHINA CONFERENCE 2011 The Objectives of QMS (contd) QMS的目的(续) Establish and Maintain a State of 建立并维持受控状态 Control Develop and use effective monitoring and control
17、systems for process performance and product quality 制定并使用用于监控工艺性能和产品质 量的有效监视和控制系统 Quality risk management can be useful in identifying the monitoring and control systems. 质量风险管理在确定监视和控制系统方 面非常有用。ISPE-CCPIE CHINA CONFERENCE 2011 The Objectives of QMS (contd) QMS的目的(续) 帮助进 Facilitate Continual Improve
18、ment 行持续改进 Identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and quality system enhancements 确定并实施适宜的产品质量改进、工艺改进 、可变因素缩减、创新和质量系统改进措施 Again quality risk management can be useful for identifying and prioritising areas for continua
19、l improvement. 同样,质量风险管理在确定持续改进区域并 确定其优先级别方面非常有用。ISPE-CCPIE CHINA CONFERENCE 2011 Design of QS QS的设计 The design, organisation and documentation of the QMS should be well structured and clear QMS的设计、组织和文件编制应具有良好的组织结构且非常明确 QS should reflect the size and complexity of the companys activities QS应反映公司业务的
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