Method Lifecycle Management

New concepts proposed by the US Pharmacopoeia in proposed chapter <1220> The Analytical Procedure Lifecycle, and the ICH quality guidelines outline a framework for the analytical method lifecycle. This gives you a structured approach for understanding and testing your method’s performance, as well as continually assuring your method is fit for its intended purpose.

Method Life Cycle Management Graph

Method Lifecycle In Depth

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.

Videos / Webinars
Leading experts introduce MLCM
Hear from key experts who are implementing MLCM

Leading experts introduce the topic of method lifecycle management (MLCM) including: key concepts and benefits; what regulators are saying; and how to leverage key technologies for MLCM.

Videos / Webinars
Pharmaceutical leaders discuss the advantages of MLCM, regulatory drivers, and technology enablers
Experts are leveraging the MLCM approach

Leading experts introduce the topic of method lifecycle management (MLCM) including: key concepts and benefits; what regulators are saying; and how to leverage key technologies for MLCM.

Videos / Webinars
Interview with The Method Detectives: Building a New Business Model with Analytical Procedure (Method) Lifecycle Management

Chromicent's analytical method innovators Alexander Schmidt and Mijo Stanic share insights on solving customers’ challenges with a novel method lifecycle management (MLCM) approach.

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.

App notes / Tech briefs
The Method Detectives: Building a New Business Model with Analytical Procedure (Method) Lifecycle Management

This case study explores how Chromicent, an innovative pharmaceutical services provider, solves customers’ challenges with a novel method lifecycle management approach to method development and validation, leading to less risk and more robust methods.

App notes / Tech briefs
Analytical Procedure (Method) Lifecycle Management Drives Method Development at Innovative CDMO
Hear from the experts

Hovione, an innovative CDMO, has proactively adopted MLCM and AQbD methodology to help its customers gain efficiencies and improve the quality of their drug products. This case study reviews key concepts and benefits, and explores the dynamic regulatory landscape in method lifecycle management today.

Publications & Whitepapers
Analytical Life Cycle Management— The Coming Revolution
Industry perspective on MLCM

This article gives a solid introduction to the Methods Lifecycle Management approach and includes a definition of the most commonly used acronyms - of which there are many. LCGC's Incognito provocatively and accurately states that they way our analytical methods are developed, validated, and verified is changing and the pharmacopeial bodies and regulators are driving this change.

Publications & Whitepapers
Lifecycle management of analytical methods
Hear it from the MLCM innovators

Using an MLCM approach you can develop more robust methods, improve efficiency during method transfers, and enhance your understanding of method parameters. Chromicent's publication covers the three stages of MLCM and explores key concepts like analytical target profile (ATP), analytical quality by design (AQbD), the regulatory landscape, and the key benefits of the method lifecycle management (MLCM) approach.

Videos / Webinars
Introduction to Analytical Procedure Lifecycle Management
Hear from the regulators

This webinar, presented by Dr. Horacio Pappa, Director of the General Chapters Department, United States Pharmacopeia (USP), and Dr. Alexander Schmidt and Mijo Stanic of Chromicent Pharmaceutical Services, describes the key concepts of method lifecycle management, its benefits to drug manufacturers and patients, and the current thinking of the USP, FDA, and ICH. Case studies will showcase how this approach is being implemented in the pharmaceutical industry.

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

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