方法生命週期管理

美國藥典在第<1220>章「分析流程生命週期」提案中介紹的全新概念以及ICH品質準則,全都概述分析方法生命週期的架構。您可以透過這種結構完整的方式理解與測試方法效能,也能持續確認您的方法是否符合其既定用途。

Method Life Cycle Management Graph

深入瞭解方法生命週期

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.

影片/網路研討會
頂尖專家介紹MLCM
Hear from key experts who are implementing MLCM

頂尖專家介紹方法生命週期管理(MLCM)主題,內容包括:重要概念與優勢;監管機關的說法;以及如何運用MLCM關鍵技術。

影片/網路研討會
一流製藥公司探討MLCM的優點、推動監管法規的誘因,以及技術推動者
專家都在運用MLCM方式

頂尖專家介紹方法生命週期管理(MLCM)主題,內容包括:重要概念與優勢;監管機關的說法;以及如何運用MLCM關鍵技術。

影片/網路研討會
訪談分析偵測工具:運用分析流程(方法)生命週期管理建構新型態業務模式

Chromicent的方法創新人員Alexander Schmidt和Mijo Stanic針對運用新穎的方法生命週期管理(MLCM)方式解決客戶難題分享深入見解。

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.

應用手冊/技術簡報
分析偵測工具:運用分析流程(方法)生命週期管理建構新型態業務模式

本案例研究探討創新製藥服務供應商Chromicent如何運用新穎的方法生命週期管理方式進行方法開發與驗證,降低風險並提高方法的穩定性,協助客戶解決問題。

應用手冊/技術簡報
分析流程(方法)生命週期管理推動創新CDMO的方法開發
專家意見

創新CDMO公司Hovione積極運用MLCM和AQbD方法,協助其客戶提高效率及加強藥物產品品質。本案例研究介紹重要概念與優勢,同時探討時下方法生命週期管理多變的監管環境。

出版資料與白皮書
分析生命週期管理—來勢洶洶的創新技術
業界對MLCM的看法

本文詳細介紹方法生命週期管理方式,並且解釋許多常見縮寫的代表含義。LCGC的Incognito強勢而準確地說明我們進行分析方法開發、確效及驗證所採用的方式出現了什麼樣的變化,以及藥典機構和監管機構又是如何促成這樣的轉變。

出版資料與白皮書
分析方法生命週期管理
MLCM創新公司的意見

運用MLCM方式可以開發出更穩定的方法,能夠提升方法轉移期間的效率,也有助於加深理解方法參數。Chromicent的出版資料介紹MLCM的三個階段,並且探討幾項重要概念,例如分析目標資料(ATP)、分析品質源於設計(AQbD)、監管環境,以及方法生命週期管理(MLCM)方式的重要優勢。

影片/網路研討會
介紹分析流程生命週期管理
監管機構的意見

本網路研討會的主講者是美國藥典(USP)通則部門主管Horacio Pappa博士,同時請到製藥服務公司Chromicent的Alexander Schmidt博士和Mijo Stanic,說明方法生命週期管理的重要概念、對藥物製造商與患者的優勢,以及USP、FDA和ICH現階段的思維。案例研究將示範製藥業如何實施這種方式。

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

Hovione and Waters instrumentation are a powerful strategy for method development.