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.
THE GOAL IS TO DEVELOP 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.
Many facilities handle dangerous processes and products on a daily basis. Keeping everything under control demands well-trained people working with the best equipment.
Enhance the training experience and increase retention by training hands-on in Emerson's Interactive Plant Environment. Build skills here so you have them where and when it matters...
See how Rosemount™ 625IR Fixed Gas Detector helps keep workers safe with ultra-fast response times to detect hydrocarbon gases before they can create dangerous situations.
