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Inventi Impact - Pharmaceutical Process Development

Articles

  • Inventi:ppd/19079/16
    CURRENT PERSPECTIVE ON OPPORTUNITIES AND ADOPTION CHALLENGES OF QBD IMPLEMENTATION IN PHARMACEUTICAL PRODUCT DEVELOPMENT
    Suruchi S Vishwasrao*, Sarabjit Singh

    This review focused on the existing circumstances of quality by design (QbD) implementation in pharmaceutical industry and regulatory bodies. QbD is a systematic approach to improve the quality of product by optimizing the process using defines variables, experimental designs, statistical principles and gives predicted reliable results. Hence this was an attempt which overview the adoption and execution of QbD principles in the development of pharmaceutical product. This review stands on comprehensive search of most relevant industry and regulatory articles, publications and web resources. The main focus of this work was on the essentials, challenges and current scenario for QbD application in all pharmaceutical organizations. It was observed that perceptions towards QbD approach immensely vary among pharma industries and also in the regulatory authorities. Current situation of QbD implementation demands more collaborative work, discussions and interactions. This could help to improve the performance of QbD approach in pharma industry. It also evaluates the QbD adoption challenges of biological products, new drug and abbreviated drug products with some examples. It outlines the understanding and application challenges of QbD approach in organizations and reveals the recent investigations and achievements in this exciting area.

    How to Cite this Article
    Suruchi S Vishwasrao, Sarabjit Singh. Current Perspective on Opportunities and Adoption Challenges of QbD Implementation in Pharmaceutical Product Development. Inventi Impact: Pharmaceutical Process Development, 2016(3):127-134, 2016.
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