"Quality by design" bei analytischen verfahren: Konsequenzen und möglichkeiten

Robustness and reliability of analytical procedures as well as their continuous improvement over the product's life cycle is a significant topic of mutual interest to both pharmaceutical manufacturers and regulatory agencies. In order to address the parallel opportunities of improving robustness and facilitation of continuous improvement within the analytical methods environment a white paper was developed in a joint effort of the PhRMA and EFPIA working groups. Two concepts were developed which are intended to stimulate further discussion within the industry and regulatory arenas. One concept is that the steps, tools and approaches developed for application of Quality by Design to manufacturing processes have analogous application to the development and use of analytical methods. The approaches which have been developed for defining critical quality attributes and process parameters for a drug product are shown to be transferable and applicable to the design, development, implementation and life-cycle management of analytical methods. Another concept presented in the paper is use of an Analytical Target Profile (ATP). It describes the method requirements needed to adequately measure the defined critical quality attributes of the drug product. The incorporation of this concept in the development cycle is viewed as having the potential to reduce the burdens of post approval variations, because the ATP would be approved instead of an individual method. Any method that complies with the ATP can be used, of course strictly following the internal change control system of the company.