A science and risk based validation approach such that only batches on the extremes of certain predetermined and justified design factors, e.g. strength, batch size and/or pack size, are tested during process validation. The design assumes that validation of any intermediate levels is represented by validation of the extremes. Where a range of strengths is to be validated, bracketing could be applicable if the strengths are identical or very closely related in composition, e.g. for a tablet range made with different compression weights of a similar basic granulation or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells. Bracketing can be applied to different container sizes or different fills in the same container closure system.

界定法：一种基于科学和风险的验证方法。用本方法做工艺验证时，只有某些预定和预判的设计因素的极限条件下生产的批次需要进行检验。这类设计因素含规格、批量和/或包装规格等。设计思路是假设任何中间水平的验证可以代表极限条件下的验证。当有一系列的规格需要验证时，如果规格相同或者组分接近，那么界定法就是适用的。比如用相同的颗粒在不同压力下压出来的片剂或者用相同的原辅料在不同充填压力下充填至不同大小的胶囊。界定法可以适用于不同的容器规格或者相同容器密闭系统下的不同填充。 Change Control

A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the

need for action that would ensure and document that the system is maintained in a validated state

变更控制：可能影响设施、系统、设备、工艺的验证状态的真实变更或由有资质的专业人士提出建议的正式系统，目的是为了确保系统维持在验证状态需要采取行动的必要性，并使之文件化。 Cleaning Validation

Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.

清洁验证：证明一个经批准的清洁程序可以重复性的去除前一产品或设备用到的

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清洁剂并使残留降低到科学设置的最大允许携带水品的文件证据。 Cleaning verification

The gathering of evidence through chemical analysis after each

batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.

清洁确认：在每批/连续性生产结束后，通过化学分析数据说明前一产品或清洁剂已经降低到科学设置的最大允许携带水品。 Concurrent Validation

Validation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialisation of the validation batches.

同步验证：在特殊情况下，经过对病人重大利益评估的基础上执行验证方案，让商业化生产和验证批同步进行。 Continuous process verification

An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. (ICH Q8)

持续工艺确认：一种工艺验证替代方法，该方法会对生产工艺性能进行持续监控和评估。（ICH Q8） Control Strategy

A planned set of controls derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications and the associated methods and frequency of monitoring and control. (ICH Q10) 控制策略：从能够确保工艺性能和产品质量的产品和工艺理解中衍生出来的一个计划性的控制集合，包括与原料药和药品原料及辅料相关的参数或属性、设施和设备的运行条件、中控措施、成品质量标准以及相关的方法、监测和控制的频率。（ICH Q10）

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Critical process parameter (CPP)

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (ICH Q8)

关键工艺参数（CPP）：其变化会对关键质量属性造成影响的工艺参数，应因此需要监测或控制以保证工艺可以生产出符合预期质量的产品。（ICH Q8） Critical quality attribute (CQA)

A physical, chemical, biological or microbiological property or characteristic that should be within an approved limit, range or distribution to ensure the desired product quality. (ICH Q8)

关键质量属性（CQA）：应当在规定限度、范围或分布内的物理、化学、生物或微生物的特征或特性以确保预期产品质量。 Design qualification (DQ)

The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.

设计确认（DQ）：证明设施、系统和设备的设计符合其预期用途的文件。 Design Space

The multidimensional combination and interaction of input variables, e.g. material attributes, and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not

considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. (ICH Q8)

设计空间：输入变量间多维的组合和相互影响，比如物料属性和工艺参数被证实可以提供质量保证。在设计空间内运行不认为是变更，超出设计空间就被认为是变更一般会引发需法规监管批准的变更程序。设计空间由申请人提出，由监管机构评估和批准。

Installation Qualification (IQ)

The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s

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recommendations.

安装确认（IQ）：为证明设施、系统和设备在安装或改造后符合已批准的设计和供应商建议的活动。 Knowledge management

A systematic approach to acquire, analyse, store and disseminate information. (ICH Q10)

知识管理：获取、分析、保存和传播信息的一种系统化的方法。 Lifecycle

All phases in the life of a product, equipment or facility from initial development or use through to discontinuation of use.

生命周期：一个产品、设备或设施从初始开发或使用至不再使用的生命中的所有阶段。

Ongoing Process Verification (also known as continued process verification)

Documented evidence that the process remains in a state of control during commercial manufacture.

连续性工艺确认（也称为持续工艺确认）：证明工艺在商业化生产中始终处于受控状态。

Operational Qualification (OQ)

The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

运行确认（OQ）：证明设施、系统和设备在安装或改造后能够在期望的操作范围内按照预期的方式运行的文件。 Performance Qualification (PQ)

The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.

性能确认（PQ）：证明系统和设备在经批准的工艺方法和产品标准的基础上可以有效地、重复地运行的文件。

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