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News from the ICH on Continuous ManufacturingICH 连续生产指南新进展
In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline oncontinuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline entitled "ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products" by means of the final version of the concept paper. As the title suggests, the new guideline addresses the manufacturing of both drug substances and drug products. To contribute to a general understanding and harmonisation, ICH Q13 will include many definitions such as: startup/shutdown, state of control, process validation, continuous process verification, etc. 在2018年6月，ICH宣布了将会发布关于连续生产的新指南。现在，ICH发布了更多消息，关于《ICH Q13:原料药和药品的连续生产》新指南的规划内容。正如题目所述，新发布的指南不仅阐述原料药并且还有药品的生产。为了促进全面的了解和协调，ICH Q13将会涵盖许多词组的定义例如：开始/停工，控制状态，验证过程，连续过程确认等。 Key elements of the new paper are: system dynamics, monitoring frequency, detection and removal of non-conforming material, material traceability, process models and process controls.Moreover, the document will also provide information about products registration: small molecules as well therapeutic proteins are explicitly named, which means that biopharmaceutical processes will also be in the scope of the guideline. Dr Sau Lee (FDA, United States) will be rapporteur of the working group and Dr Yoshihiro Matsuda from the Japanese Authority (MHLW/PMDA), regulatory chair. 新指南要素为：动态系统、监控频率、检测和剔除不合格物料、物料可追溯性、流程模型和过程控制。此外，指南还提到了产品注册相关信息：药用小分子蛋白质，意味着此指南的范围也包括生物药生产过程。Sau Lee（FDA，美国）为工作组书记，Yoshihiro Mastsuda 来自日本药监局，为工作组主席。 The elaboration of the paper is planned to take three years. 这份指南的拟订工作计划用三年时间。 ICH网站上可以下载概念性文件最终版本。
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发表于 2019-1-17 10:07:29
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