Kelley Brian, Cromwell Mary, Jerkins Joe
Pharma Technical Development, Genentech, South San Francisco, CA 94080, USA.
Pharma Technical Development, Genentech, South San Francisco, CA 94080, USA.
Biologicals. 2016 Sep;44(5):341-51. doi: 10.1016/j.biologicals.2016.06.001. Epub 2016 Jul 25.
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 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 how the risk assessments, logic and interactions of the tools are designed to connect the set of QbD tools and elements into an overarching risk management system. The tools allow comparisons of options based on elective decisions that the sponsor could take and reflect relative values of these options. The overall risk management strategy assures product quality from this enhanced set of assessments and employs a science and risk based approach resulting in a consistent and transparent set of process and product controls and a rational monitoring system.
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制药生产工艺和控制措施，以持续实现产品预期性能，从而加强药物研发。与QbD相关的药物研发原则在国际人用药品注册技术协调会（ICH）指导文件（ICHQ8 - 11）中有描述。罗氏/基因泰克公司制定的一套综合风险评估及相关要素，旨在概述重组单克隆抗体制备过程中的产品和工艺知识。本章描述了风险评估、工具的逻辑及相互作用是如何设计的，以便将QbD工具和要素集连接成一个总体风险管理系统。这些工具允许基于申办者可能做出的选择决策对各种选项进行比较，并反映这些选项的相对价值。整体风险管理策略通过这一强化评估集确保产品质量，并采用基于科学和风险的方法，从而形成一套一致且透明的工艺和产品控制措施以及一个合理的监测系统。
