Upgrade Your PET Manufacturing Practices by Implementing Quality Risk Management

藉由執行品質風險管理來升級你的正子斷層造影製程步驟

Tyson Scott Skriver ； Pi-Chiang Hsu

《核子醫學暨分子影像雜誌》 34卷2期 (2021/06) Pp. 61-68

https://doi.org/10.6332/ANMMI.202106_34(2).0001

摘要

Positron emission tomography (PET) drugs play increasingly more roles in the application of modern medical treatments. Therefore, regulatory officers are implementing increased controls over PET drug productions to ensure patients' safety and announcing more regulatory requirements for PET drug manufacturers to follow. It is important for PET drug manufacturers to be compliant with current good manufacturing practice (cGMP). However, there are limited resources, so how to prioritize resources on the needed areas in response to this increasing regulatory burden has been widely discussed. Quality risk management (QRM) is a quality tool designed to use a risk- and scientific-based approach to systematically filter out higher priority items. Here, we introduce the fundamental structure of QRM and show some examples to demonstrate how to execute a QRM project. In addition, we provide some high-level concepts on how to integrate QRM into existing quality systems from a drug lifecycle perspective. Based on this article, PET drug manufacturers can apply QRM to efficiently control product quality and maintain compliance with cGMP requirements to ensure the safety of patients.

關鍵字

PET ； cGMP ； QRM

並列摘要

正子斷層造影藥物在新型的醫藥治療行為上扮演越來越多的角色。因此法規主管機關為確保用藥人之安全，對正子斷層造影藥物的製造實行了更多的控管，並且也頒布了更多的法規命令給正子斷層造影藥物的製造業者去遵循。對正子斷層造影藥物製造業者來說，遵循藥品優良製造規範很重要。但是因為這些法規要求日益增加，因此在有限的資源下如何將資源優先放在必要的地方上已被廣泛的討論。品質風險管理是個以風險和科學為基礎而設計出來的品質工具，它可以有系統性的篩選出需要被優先處理的事項。在此，我們將介紹品質風險管理的基礎結構並且列舉一些如何執行品質風險管理計畫的例子。此外我們也提供了一些如何從整個產品生命週期的觀點來將品質風險管理整合入已存在的各項品質系統中的高階觀念。根據此篇文章，正子斷層造影藥物製造業者可通過執行品質風險管理來有效的控制產品品質並且確保自身能遵循藥品優良製造規範來保護用藥人之安全。

並列關鍵字

正子斷層造影 ； 藥品優良製造規範 ； 品質風險管理