Over their lifetime, analytical methods may have challenges meeting their original required criteria. These occurrences may be due to a number of parameters, including changes in instrumentation or columns, changes in other parameters that are not well understood, new technology, drug substance or drug product modifications, or a trend that occurred over the life of the method. To ensure methods are more robust and that there is improved control of method performance, Method Lifecycle Management (MLCM) can be considered.
MLCM is a strategy that is intended to improve the performance of analytical methods, and to assure those methods perform as originally intended over their entire lifetime. It uses a structured approach that includes:
Analytical Target Profile (ATP)
Stage 1 – Method Design and Development
Stage 2 – Method Qualification
Stage 3 – Method Performance Verification
MLCM is a fluid process, in that any modifications to a method in latter stages may require the previous stages be revisited, and a risk assessment to be carried out and some level of revalidation may be required. However, with this approach, a laboratory can: improve the performance of methods; reduce analytical uncertainties such as out-of-specification (OOS) and out-of-trend (OOT) results; minimize the need for post approval method changes; and improve the success of method transfers to other laboratories.