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

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

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

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
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).