Method Lifecycle Management, MLCM, is a control strategy ensuring that, as long-term methods evolve, they perform as originally intended throughout their lifetime.

Changes in production materials, analytical instrumentation, consumables, or modifications to the drug product can have an impact of a validated method to continue to meet original criteria.

Challenges also extend to inter-laboratory method transfer either internally or to outsourcing partners such as contract research organisations (CROs). It is critical that from development and analytical method validation, through to method transfer and long-term performance monitoring that continuous knowledge of the method is captured and used to asses the impact of any changes in the future such as a change in manufacturing process or a change in the analytical column used for separation.

What is Method Lifecycle Management?

Important stages of Method Lifecycle Management

Analytical Target Profile (ATP) 

ATP underpins all stages and states the requirements of the analytical procedure at all stages, such as accuracy and precision. The ATP is driven by the known CQAs of the product.

Important stages of method lifecycle management

Method design and development

Method design and development requires an upfront knowledge of the products critical quality attributes (CQAs), often by the implementation of Analytical Quality by Design (AQbD). Instruments are required to have flexibility in use to facilitate parameter adjustments, and automated features built in to both speed up, and ease the burden of screening method parameters and consumables.

Method qualification

Method qualification requires robust technology and software to give confidence the developed method will perform as expected over an extended period.

Method verification

Method verification requires long term monitoring of the method, including when changes happen such as method transfer or a change in production. Implementing new technology typically allows for more improved methods, but the impact on legacy methods must be minimal and monitoring of CQAs is not compromised.

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Pharmaceutical applications compendium

Quality control (QC) testing of pharmaceuticals must be rigorous and involves multiple techniques including GC-MS, LC-MS, ion chromatography, and elemental analysis techniques. Impurities can take many forms, from solids to volatiles and everything in between. We have solutions for pharmaceutical testing organizations conducting small molecule impurities; from method development to transfer you can find the applications you need in this compendium.

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Enhance your capabilities - Pharmaceutical applications compendium

Empowering success by adopting new LC instruments within an existing network

Having previously standardized on Waters Empower® 3 Chromatography Data Software, it was required that any analytical equipment Patheon adopted could be operated under this environment. Deployment of the Vanquish UHPLC system at Patheon sites across the globe has enabled improvements in assays such as released glycan analysis, peptide mapping and monitoring, as well as purity and ratio analysis

Thermo Scientific Vanquish Core HPLC system cost of ownership

The economic value that the Vanquish systems can bring to your lab is significant. By improving the user interface and experience, and making the instrument more intelligent, we can reduce the number of interruptions and reduce the amount f time required to run samples again after unexpected downtime. By improving system performance, efficiency and impact on wearable parts and consumables, more time can be spent running samples and generating revenue.

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Phase Appropriate Analytical Equipment and Method Lifecycle Management – Expert roundtable discussion

In this roundtable discussion, experts from Pharmaron UK will introduce the analytical method life cycle and why it is needed. Kieron McIntyre and Peter Adefuye will bring up points about a risk-based approach to equipment validation, continuous equipment validation, and system retirement. We will also learn from two case studies in life cycle management. Join the conversation and submit questions for our panel!

Overcoming the challenges of liquid chromatography method transfer: A CDMO perspective

Analytical method transfer and method modernization can be a barrier to upgrading to the latest technologies. Revalidating an existing method while continuing to meet regulatory guidance can be a challenging and time-consuming endeavor. However, method modernization is often less difficult than the common perception, and good practices can be put in place to streamline and facilitate the process.

Style Sheet for Global Design System