ich-Q10（中英文对照） - 图文

quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements.

The regional GMPs do not explicitly address all stages of 地区的ＧＭＰ没有明确列出产品生命周期的所the product lifecycle (e.g., Development). The quality 有阶段（如，研发）。此指南描述的质量体系基system elements and management responsibilities 础和管理职责用于鼓励在每个生命周期阶段使described in this guideline are intended to encourage the 用科学和风险管理方法，因而在全部的产品生命use of science and risk based approaches at each lifecycle 周期中促进持续改进。 stage, thereby promoting continual improvement across the entire product lifecycle. 1.4

Relationship of ICH Q10 to Regulatory Approaches

Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Potential opportunities to enhance science and risk based regulatory approaches are identified in Annex 1. Regulatory processes will be determined by region. 1.5

ICH Q10 Objectives

Implementation of the Q10 model should result in achievement of three main objectives which complement or enhance regional GMP requirements. 1.5.1 Achieve Product Realisation

To establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care

professionals, regulatory authorities

(including compliance with approved regulatory filings) and other internal and external customers. 1.5.2 Establish and Maintain a State of Control

To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.

1.4 ICH Q10和法规方法的关系 特定产品或生产车间的法规方法应与产品和工艺的理解水平，质量风险管理结果和制药质量体系效果相对应。一旦实施，制药质量体系的有效性一般会在生产现场的官方审计过程中得到评价。基于法规方法对科学和风险进行改进的潜在机会如附件１所示。法规程序由各地区确定。 1.5 ICH Q10目的

Ｑ１０模型的执行应该导致三个主要目标的完成，补充或提升地区ＧＭＰ要求。 1.5.1 获得产品实现

建立，实施和维护一体系以允许产品的交付合适地满足患者，保健专业人员，药政机构（包括符合批准的法规）和其它内部和外部的顾客。 1.5.2控制状态的建立和实现

开发和使用工艺性能和产品质量的有效监控和控制体系，以此为工艺持续适宜性和性能提供保证。质量风险管理有助于监控和控制体系的确定。 Page 5 of 28

1.5.3 Facilitate Continual Improvement improvements,

process

improvements,

1.5.3 有助于持续改进

variability 动减少，创新和制药质量体系改进，以此提高持

To identify and implement appropriate product quality 确定和实施适宜的产品质量改进，工艺改进，变reduction, innovations and pharmaceutical quality 续满足需求的能力。质量风险管理有助于改进领system enhancements, thereby increasing the ability to 域的确定和优先排序。 fulfil

quality

needs

consistently.

Quality

risk

management can be useful for identifying and prioritising areas for continual improvement.

1.6 Enablers: Knowledge Management and Quality 1．6支持者：知识管理和质量风险管理 Risk Management

Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described in Section 1.5 above by providing the means for science and risk based decisions related to product quality. 1.6.1 Knowledge Management

Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example,

development

activities

using

scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach

to

acquiring, analysing, storing and disseminating

information

related

to

products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing

experience;

innovation;

continual improvement; and change management

activities.

1.6.2 Quality Risk Management

知识管理和质量风险管理的使用将使公司有效

并顺利地执行ICH Q10。 它们有助于实现上述1.5章节所述的目的，为与产品质量相关的基于科学和风险的决定提供方法。 1．6．1知识管理

产品和工艺知识管理应从开发一直到产品的商业生命，并包括产品终止。比如，研发活动通过科学的方法为产品和工艺理解提供知识。知识管理是获得，分析，保存和公布产品制造，工艺和组分相关信息的系统方法。知识来源包括，但不限于，先前知识（公共领域或内部文件），药物开发研究，技术转移活动，产品生命周期内的工

艺验证，生产经验，持续改进和变更管理活动。

1．6．2质量风险管理

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质量风险管理是有效的制药质量体系的不可分割的部分。它能提供确定，科学评价和控制潜在pharmaceutical quality system. It can provide a

质量风险的前摄性方法。它有助于产品生命周期proactive approach to identifying, scientifically

evaluating and controlling potential risks to quality. It 内工艺性能和产品质量的持续改进。ICH Q9提facilitates continual improvement of process performance 供了用于制药质量不同方面的质量风险管理工

Quality risk management is integral to an effective and product quality throughout the product lifecycle.

ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

1.7 Design and Content Considerations

(a) The design, organisation and documentation of

the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application.

(b) The elements of ICH Q10 should be applied in a

manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the different goals and knowledge available for each stage.

(c) The size and complexity of the company’s

activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.

(d) The pharmaceutical quality system should

include appropriate processes, resources and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in Section 2.7.

(e) Management responsibilities, as described in

Section 2, should be identified within the pharmaceutical quality system. (f) The pharmaceutical quality system should include the following elements, as described in Section 3: process performance and product quality monitoring, corrective and preventive action, change management and management review.

(g) Performance indicators, as described in Section

4, should be identified and used to monitor the effectiveness of processes within the pharmaceutical

具的原则和例子。 1．7设计和内容方面的考虑点

(a)制药质量体系的设计，组织和文件应清晰，并有良好的结构，能有助于共识和持续应用。

(b)ICH Q10要素的应用需与产品生命周期的各个阶段相适应，应认识到各个阶段的不同目标和有用的知识。

(c)在开发新的制药质量体系或对现有体系进行改进时，应考虑到公司活动的规模和复杂性。制药质量体系的设计应适当地与风险管理原则相结合。当制药质量体系的有些方面是公司范围的而其它的是场地特定的，则制药质量体系效果一般来说应在场地这个水平上进行阐述。

(d)制药质量体系应包括适当的工艺，资源和职责，按2.7章节描述的为外包活动和采购物料提供质量保证。

(e)制药质量体系中应确定第2章节中所叙述的

管理职责。 (f)制药质量体系应包括第3章节所述的如下要素：工艺性能和产品质量监控，纠正和预防措施，变更管理和管理评审。

(g) 应当确认第4章节描述的性能指标，并用于

监控制药质量体系内程序的有效性。

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quality system.

1.8 Quality Manual 1．8质量手册

A Quality Manual or equivalent documentation approach 应建立质量手册或相当的文件，质量手册应包括should be established and should contain the description 制药质量体系的叙述。叙述应包括 of the pharmaceutical quality system. The description should include:

(a) The quality policy (see Section 2); (b) The scope of the pharmaceutical quality system;

(c) Identification of the pharmaceutical quality

system processes, as well as their sequences, linkages and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner;

(d) Management responsibilities within the

pharmaceutical quality system (see Section 2).

2. MANAGEMENT RESPONSIBILITY

Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. 2.1 Management Commitment

(a) Senior management has the ultimate

responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and

authorities are defined, communicated and implemented throughout the company.

(b) Management should:

(1) Participate in the design, implementation,

monitoring and maintenance of an effective pharmaceutical quality system;

(2) Demonstrate strong and visible support for the

pharmaceutical quality system and ensure its implementation throughout their organisation;

(3) Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;

(a)质量方针（见章节2）

(b)制药质量体系的范围 (c)确定制药质量体系的程序，以及它们的顺序，

联系和相互依赖性。流程图是有用的工具，能形象地描述制药质量体系的程序。

(d)本文章节2中叙述制药质量体系管理职责。 2．管理职责

领导力对于建立和维护公司范围内的质量承诺及制药质量体系的施行是必要的。 2．1管理承诺

(a)最高领导对有效制药质量体系的运行负最终责任，以完成质量目标，这些作用，职责和权力应在整个公司内确定，沟通和执行。

(b)管理应当：

(1)参与有效制药质量体系的设计，实施，监控和维护

(2)给予支持制药质量体系以强力可见的支持，并确保其在整个组织内的执行

(3)确保有及时有效的沟通和上报流程，能将质

量问题呈报到适宜的管理级别。 Page 8 of 28