EU GMP Annex 15 Qualification and Validation

EU GMP annex 15 Qualification and Validation (draft)

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.

始于预定目标，强调产品和工艺理解和工艺控制，基于科学和质量风险管理的系统方法。 Quality risk management 质量风险管理

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

贯穿产品生命周期，对质量风险进行评估、控制、沟通和审核的系统过程。 Simulated Product 模拟产品

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. In many cases, these characteristics may be satisfied by a placebo product batch.

与被验证产品的物理性质和化学性质（如粘度、粒度、PH值等）非常相似的产品。多数情况下，这些特性要求可由安慰剂满足。 State of control 控制状态

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

通过一系列控制措施，使工艺性能和质量属性处于持续保证状态。 Traditional approach 传统方法

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

一种产品开发方式，通过对工艺参数设定控制点和操作范围的方式确保质量的重复性。 Worst Case 最坏条件

A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.

导致产品及工艺失败的概率超过正常工艺的条件或状态，即标准操作规程范围以内工艺的上限和下限。但这类条件不一定必然导致产品或工艺不合格

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