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【转载】ICH Q8 (CH&EN) 5  

2012-11-27 16:13:55|  分类: 生物医药产业 |  标签: |举报 |字号 订阅

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本文转载自Julia《ICH Q8 (CH&EN) 5》
3. GLOSSARY术语
Continuous Process Verification:持续工艺确认
An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. 工艺验证的一种替代方式,指对生产工艺的情况进行持续的监控和评估。
Design Space: 设计空间
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. 已被证明可以保证质量的输入变数(如原料)和工艺参数的多维结合及及相互作用。在设计空间内运行通常不被认为是变更。超出了设计空间就会被看作是变更,通常会需要启动规定的事后批准变更程序。设计空间由申请人提议,通过规定的评估和批准程序生效。
Formal Experimental Design: 正式实验设计
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as “Design of Experiments”. 一个结构化的有组织的方法,用于确定工艺影响因素和工艺产物之间的关系。也被称为“实验设计”。
Lifecycle生命周期:
All phases in the life of a product from the initial development through marketing until the product’s discontinuation.产品从最初的开发,经过市场周期,直至产品废止所经历的所有阶段。
Process Analytical Technology (PAT): 工艺过程分析技术(PAT)
A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.  通过对原料和中控物料及所保证最终产品质量为目的的工艺的关键质量和性能属性的实时测量(例如,在工艺过程进行中),来对制造进行设计、分析和控制的系统。
Process Robustness工艺耐受性:
Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality. 工艺可以承受原料不稳定、工艺和设备改变而不会对质量产生影响的能力。
Quality:  质量
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity (from ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances). 一个原料药或制剂对其使用目的的适合性。本术语包括这样一些属性如鉴别、剂量和纯度(源自ICH Q6A 质量标准: 新原料药和新制剂药的检验方法和可接受标准:化学物质)。
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