方法生命周期管理

美国药典拟议章节<1220>“分析流程生命周期”中提出的新概念,以及ICH质量指南概述了分析方法生命周期的框架。您可以利用这种结构化方法理解和测试方法性能,以及持续保证您的方法适用于其预期用途。

Method Life Cycle Management Graph

深入了解方法生命周期

Blogs / Articles
Simultaneous detection of nitrosamines and other sartan-related impurities in active pharmaceutical ingredients by supercritical fluid chromatography.

Since July 2018, the pharmacological class of "sartans" has been the subject of considerable media and analytical interest, as it became known that they are contaminated with nitrosamines such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDiPA). 

Blogs / Articles
A Better Lifecycle for Analytical Methods?

To this end, Hovione, a global contract development and manufacturing organization (CDMO), has proactively adopted method lifecycle management techniques (MLCM) for its chromatographic and detection systems, many of which it sources from instrument supplier Waters Corporation

Blogs / Articles
Future-Proofing Pharmaceutical Analytical Method Development With an AQbD Approach

The lifecycle of analytical procedures, also known as analytical methods, for pharmaceutical development and manufacture depends on the reliability, robustness, and accuracy of analytical measurements. 

Blogs / Articles
Implementing a More Structured Approach to Analytical Method Development
The adoption of lifecycle management to ensure the quality of pharmaceutical products

The modern concept of method lifecycle management (MLCM) provides a framework for defining the criteria and development of analytical methods, aiming to give a more structured alternative to analytical method development.

Blogs / Articles
Building a New Business Model with Method Lifecycle Management
An increased focus on lifecycle management for analytical methods has been seen in recent years from the industry’s regulatory bodies.

Method lifecycle management (MLCM) provides an opportunity to continuously improve and ensure quality of data through the application of quality risk management.

视频/网络研讨会
顶尖专家介绍MLCM
Hear from key experts who are implementing MLCM

顶尖专家介绍方法生命周期管理(MLCM)主题,内容包括:关键概念和优势、监管机构的观点,以及如何利用MLCM的关键技术。

视频/网络研讨会
制药业先驱讨论了MLCM的优势、法规驱动力,以及技术赋能因素
专家正在运用MLCM方法

顶尖专家介绍方法生命周期管理(MLCM)主题,内容包括:关键概念和优势、监管机构的观点,以及如何利用MLCM的关键技术。

视频/网络研讨会
浅谈方法侦探:利用分析流程(方法)生命周期管理构建全新的商业模式

Chromicent分析方法创新者Alexander Schmidt和Mijo Stanic分享了他们对于使用新型方法生命周期管理(MLCM)方式解决客户难题的看法。

Videos / Webinars
Analytical Procedure MLCM Drives Method Development at Innovative CDMO

Learn how Hovione, a global CDMO, has determined that the combination of Waters instrumentation and AQbD is a powerful strategy for method development that leads to better, faster, greener analytical methods, enables resource optimization and more.

App notes / Tech briefs
Method Lifecycle Management (MLCM) Compendium

To ensure methods are more robust and that there is improved control of method performance, Method Lifecycle Management (MLCM) can be considered. 

App notes / Tech briefs
Robust and Rapid Method for Analysis of Active Pharmaceutical Ingredients in Multi-Component Cold and Flu Medication
Reproducible and robust methods with a systematic approach

A good example to show how to employ a systematic method development protocol with a MLCM concept and obtain a robust and reproducible method in a faster and effective way.

应用纪要/技术简报
方法侦探:利用分析流程(方法)生命周期管理构建全新的商业模式

本案例研究探讨了创新型制药服务提供商Chromicent如何通过新型方法生命周期管理方式,开发和验证方法,得到风险更低、更稳定的方法,从而解决客户难题。

应用纪要/技术简报
分析流程(方法)生命周期管理推动了创新CDMO的方法开发
听取专家观点

一家创新CDMO公司Hovione积极采用MLCM和AQbD方法来帮助客户提高效率并改善其药品质量该案例研究介绍了关键概念和优势,探讨了现阶段方法生命周期管理中的动态监管环境。

出版物和白皮书
分析生命周期管理 — 即将到来的重大变革
业内对MLCM的看法

本文对方法生命周期管理方式进行了详细介绍,还介绍了大量常用缩写词的定义。LCGC的Incognito热情又客观准确地指出,我们开发、验证和确认分析方法所用的方式发生了变化,药典机构和监管机构正在促成这场变革。

出版物和白皮书
分析方法生命周期管理
听取MLCM创新者的观点

通过MLCM方式可以开发出更稳定的方法,提高方法转移效率,并且加深对方法参数的理解。Chromicent的出版物介绍了MLCM的三个阶段,并探讨了分析目标特征(ATP)、分析质量源于设计(AQbD)、监管环境等关键概念,还探讨了方法生命周期管理(MLCM)方式的重要优势。

视频/网络研讨会
分析流程生命周期管理简介
听取监管机构的观点

本次网络研讨会的主讲人有美国药典(USP)通用章节部门主任Horacio Pappa博士,以及制药服务公司Chromicent的Alexander Schmidt博士和Mijo Stanic,会上介绍了方法生命周期管理的关键概念、对制药企业和患者的优势所在,以及目前对USP、FDA、ICH的看法。案例研究将展示如何在制药行业实施该方法。

视频/网络研讨会
分析流程的MLCM可有效推进方法开发

Hovione和沃特世仪器将为方法开发提供强有力的解决方案。