欧盟GMP附录15：确认与验证（修订版英文+中文）

Process Validation

The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. 工艺验证：证明在规定的参数范围内操作均可以有效地和重复性地生产出符合预定质量标准和质量属性的产品的文件。 Product realisation

Achievement of a product with the quality attributes to meet the needs of patients, health care professionals and regulatory authorities and internal customer requirements. (ICH Q10)

产品实现：产品的质量属性能够与病人、医护人员、监管机构和内部客户的要求相符。（ICH Q10） Prospective Validation

Validation carried out before routine production of products intended for sale. 前验证：在计划用于上市销售的常规化生产之前进行的验证活动。 Quality by design

A systematic approach that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.

质量源于设计：基于科学和质量风险管理，从预定目标开始，以产品和工艺理解及工艺控制为重点的一套系统性方法。 Quality risk management

A systematic process for the assessment, control, communication and review of risks to quality across the lifecycle. (ICH Q9)

质量风险管理：贯穿于产品生命周期，对质量存在的风险进行评估、控制、沟通和审核的一套系统化流程。（ICH Q9） Simulated agents

A material that closely approximates the physical and, where practical, the chemical characteristics, e.g. viscosity, particle size, pH etc., of the product under validation.

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模拟试剂：在验证中，与产品的物理性质和化学性质（如粘度、颗粒度、pH值等）非常接近的物料。 State of control

A condition in which the set of controls consistently provides assurance of acceptable process performance and product quality.

控制状态：以一系列的控制措施持续地保证工艺性能和产品质量处于可接受的状态。

Traditional approach

A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility.

传统方法：为确保重现性，定义工艺参数的设置点和操作范围的产品开发的方法。 Traditional approach

A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility.

最差条件：相对于理想条件，在标准操作范围内，有一个或一组包含工艺上下限度和条件的最差情况，在这种情况下工艺面临最大可能的失败，但不一定会导致工艺或产品的失败。

User requirements Specification (URS)

The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system. 用户需求说明（URS）：由所有者、使用者以及必要且充足的工程人员组成，为符合系统预期目的而进行的可行性设计。

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