QbD Approach at the Research and Development Stage itself involving due diligence particularly (but not limited to) with respect to Risk Assessment and Mitigation ensures time and cost saving processes ensuring consistent and high Quality of both APIs and FPPs.
Pharmaceutical Development Process at the Research and Development Level has to ensure identification & implementation of Key elements of ObD by adopting suitable tools.QbD Approach to API & Formulation Development has to be ensured at both Chemical Research/ Product development and Analytical Research Development and needs to be translated into a viable product at the production scale via successful Technology transfer and Scale- up operations.
The QbD approach not only convinces the Regulators and Facility Inspectors of a thorough understanding of our manufacturing and analytical processes but also ensures achieving and maintaining the established/prescribed/desired product quality thereby expediting the approval of Marketing Authorization Application Dossiers in multiple global markets which ultimately meets the Business aspirations of Pharmaceutical Organizations and also ensures that Quality medicines are available to the end-users.
This success of adopting the ObD approach is the gateway for achieving and arriving at a time- saving and cost-saving process ensuring a high-quality and stable product consistently.
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