Achieving the Goals of QbD and PAT - Bridging the Gap Between Process Development and Manufacturing

Quality by Design (QbD) starts in process development. This is where the best opportunity exists to design improved processes based on new process measurements and by taking advantage of previous experiences with similar processes. With the introduction of Process Analytical Technology (PAT) as a tool for achieving QbD in pharmaceutical and biotechnology processes, the volume of electronic and paper-based data collected during process development and manufacturing has increased dramatically. A critical success factor for achieving the goals of QbD is thus to provide on-demand access all of this data for end users in a collaborative analytics, trending and reporting environment in which the multidisciplinary team can collaborate productively. The most important requirements for this system are: a simple user-centric interface for direct, on-demand access to all the data from disparate sources; a practical way to capture paper-based data and make it easily available in electronic form; the ability to work with continuous (on-line) and discrete data together; sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites; simplifying the preparation and distribution of analysis results; and automating the generation of periodic reviews and reports of batches and campaigns. This presentation will illustrate how these requirements can be satisfied with technologies readily available today.

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