Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
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.
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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).
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.
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.
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.
Method lifecycle management (MLCM) provides an opportunity to continuously improve and ensure quality of data through the application of quality risk management.
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.
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.
Chromicent's analytical method innovators Alexander Schmidt and Mijo Stanic share insights on solving customers’ challenges with a novel method lifecycle management (MLCM) approach.
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.
To ensure methods are more robust and that there is improved control of method performance, Method Lifecycle Management (MLCM) can be considered.
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.
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.
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.
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.
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.
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.
Hovione and Waters instrumentation are a powerful strategy for method development.
