Establishing a control system using QbD principles
Establishing a control system using QbD principles
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DOI：
10.1016/j.biologicals.2016.06.003
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发表时间：
2016-09-01
期刊：
影响因子：
1.7
通讯作者：
Taticek, Ron
中科院分区：
文献类型：
--
作者：
Kepert, J. Felix;Cromwell, Mary;Taticek, Ron
质量源于设计 (QbD) 是一项全球监管举措，其目标是通过主动设计药品制造工艺和控制来增强药品开发，以始终如一地提供产品的预期性能。 ICH 指导文件 (ICHQ8-11) 中描述了与 QbD 相关的药物开发原则。罗氏/基因泰克开发的一套综合风险评估及其相关要素旨在提供重组单克隆抗体生产的产品和工艺知识概述。本章介绍了用于为产品变体和工艺相关杂质建立验收标准和属性测试策略 (ATS) 的元素和工具。 CQA 的可接受范围是根据其对功效和安全性/免疫原性的潜在影响而设定的。这种方法的重点是管理患者影响，而不是简单地保持一致的分析概况。 ATS 工具旨在识别需要过程和/或测试控制的质量属性，或者可以在监控系统中捕获的质量属性，以实现控制策略的生命周期管理。 (C) 2016 年国际生物标准化联盟。由爱思唯尔有限公司出版。保留所有权利。
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes the elements and tools used to establish acceptance criteria and an attribute testing strategy (ATS) for product variants and process related impurities. The acceptable ranges for CQAs are set based on their potential impact on efficacy and safety/immunogenicity. This approach is focused on the management of patient impacts, rather than simply maintaining a consistent analytical profile. The ATS tools were designed to identify quality attributes that required process and/or testing controls, or that could be captured in a monitoring system to enable lifecycle management of the control strategy. (C) 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.