QbD implementation and Post Approval Lifecycle Management (PALM)
QbD implementation and Post Approval Lifecycle Management (PALM)
复制标题
DOI：
10.1016/j.biologicals.2016.06.007
复制
发表时间：
2016-09-01
期刊：
影响因子：
1.7
通讯作者：
Vega, Maria
中科院分区：
文献类型：
--
作者：
Ohage, Ettore;Iverson, Raquel;Vega, Maria
质量源于设计（QbD）是一项全球监管举措，旨在通过积极设计药品生产工艺和控制来加强药品开发，以始终如一地提供产品的预期性能。与QbD相关的药物开发原则见ICH指导文件（ICHQ 8 -11）[1-3]。在Roche/Genentech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。本章描述了实施单克隆抗体控制策略的概念，包括常规商业生产的设计空间，以及用于管理商业生命周期内任何剩余风险的批准后生命周期管理（PALM）计划。PALM计划是区域章节中提交的档案的一部分，作为生产商和卫生监管机构之间的监管协议，规定如何监测工艺和产品属性，以确保两者在批准后保持在受控状态，在设计空间内管理工艺参数变更，并根据进一步的工艺和产品知识在必要时更新控制系统。(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) [1-3]. 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 concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Life cycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge. (C) 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.