The Use of the Analytical Target Profile in the Lifecycle of an Analytical Procedure: with an example for an HPLC Procedure | IVT

In this paper, we illustrate the application of the lifecycle management approach for an analytical procedure (a drug substance potency test) and showed how a decision rule is used to develop the analytical target profile (ATP). The ATP is then used to define the fitness of the method for its intended use, which in turn enables an objective assessment of the method performance during initial validation, transfer to the quality control laboratory (QCL), and its ongoing performance in the QCL.The lifecycle approach is essentially applying Quality by Design (QbD) principles to the execution of the method to produce a result, in an analogous way that QbD is applied to a manufacturing process producing a product. 

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