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Life Cycle Concept

In modern process management the life cycle concept gains more and more importance.

It focusses on the total costs of the process from invest to operation and finally retirement. Also for analytical procedures an increasing interest for this concept exists in the recent years.

The life cycle of an analytical method consists of design, development, validation (including instrumental qualification, continuous method performance verification and method transfer) and finally retirement of the method.

The lifecycle approach for an analytical procedure is outlined in the figure and is an extension of the current guidelines, taking advantage of the Quality-by- Design approach.

It appears, that also regulatory bodies have increased their awareness on life cycle management for analytical methods.

Thus, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the United States Pharmacopeial Forum discuss the enrollment of new guidelines that include life cycle management of analytical methods. The US Pharmacopeia (USP) Validation and Verification expert panel already proposed a new General Chapter <1220>The Analytical Procedure Lifecycle” for integration into USP.

Furthermore, also in the non-regulated environment a growing interest on life cycle management is seen. Quality-by-design based method development results in increased method robustness. Thereby a decreased effort is needed for method performance verification, and post-approval changes as well as minimized risk of method related out-of-specification results. This strongly contributes to reduced costs of the method during its life cycle.

Chromicent has already converted the entire laboratory process to the life-cycle concept. Chromicent’s method development is based on the life-cycle approach enabling Chromicent to offer its customers and co-operation partners not only a cost-efficient but above all a highly innovative, forward-looking and future-proof concept in the field of analytical method development.

Further publications by Chromicent: Life cycle management of analytical methods & Journal of Pharmaceutical and Biomedical Analysis.