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Bhusnure O.G.*, Gholve S.B., Suryawanshi R.N, Sugave R.V., Sangshetti J N.


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. Results generated using analytical procedures provide the basis for key decisions regarding compliance with regulatory, compendial, and manufacturing limits. The results are applied against Decision Rules that give a prescription for the acceptance or rejection of a product based on the measurement result, its uncertainty, and acceptance criteria, taking into account the acceptable level of the probability of making a wrong decision. The Analytical Target Profile (ATP), risk management, control strategy, and knowledge management are cornerstone concepts in lifecycle management. 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. Application of lifecycle management concepts to analytical procedures provides an opportunity to use the knowledge gained from the application of scientific approaches and quality risk management to continual improvement and assurance of data quality. 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.

Keywords: Life Cycle Assessment, Analytical Method Development, ATP, Risk Management, Control Strategy, Knowledge Management.

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