Are standard operating procedures Passé?

Jan. 27, 2014
Analytical method development is now moving beyond simply defining a fixed set of measurement parameters.

As the philosophy and techniques enshrined in Quality by Design (QbD) become second nature to the pharmaceutical industry, their application is spreading. Analytical method development is a current area of focus. The process of developing, validating and deploying analytical methods closely parallels product development and can similarly benefit from the systematic and scientific approach that QbD promotes. The dependence of pharmaceutical development and manufacture on robust analytical data intensifies the need for rigor in analytical method development and increasingly a QbD approach — Analytical QbD (AQbD) — is seen as the way forward.

In analytical method development the goal is to develop, validate and deploy a method for making an analysis that will deliver the information required, in all the instances that it is required to do so. The starting point is to identify exactly why the measurement is being made; in the same way that the starting point for conventional QbD is to identify clinical performance targets for the product. Once this is established, the process is one of understanding and learning to control those aspects of the measurement method that define critical elements of analytical performance. This closely mirrors the QbD model of working toward a fully scoped design space.

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