Analytical method lifecycle is a continuous process that improves and documents the understanding of the capabilities of each analytical method used throughout the clinical development of a new drug candidate. Of key importance, analytical lifecycle-related activities have to be appropriately staged in accordance with the regulatory requirements without neglecting the financial and time constraints incurred by each project. Currently, regulatory requirements for analytical methods are primarily directed at prerequisites for commercial manufacturing, the end point of the development process, without any description of requirements regarding the stepwise development leading to validation. This article proposes an analytical lifecycle roadmap that will stage the various steps involved in analytical method development while attempting to meet the expectations of the stakeholders involved in the management of project risk, development costs, and regulatory compliance.
Analytical method lifecycle refers to the combined activities of analytical method development, improvement, qualification, validation, transfer, and maintenance related to GMP production. An integrated approach to analytical lifecycle must ensure that analytical methods evolve from initial development to commercial use in a manner that is best suited for their intended use at the various clinical stages on the way to commercialization. Building an analytical lifecycle roadmap that satisfies all requirements must be supported by strong technical expertise as well as sound business and regulatory knowledge.