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  • QBD Part1

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    Abhay Deulkar
    8 views2 pages
    Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with defined objectives and emphasizes product and process understanding based on sound science and quality risk management. The key objectives of QbD are to achieve product quality specifications based on clinical performance, increase product development and manufacturing efficiency, enhance root cause analysis and post-approval change management, and increase regulatory compliance. QbD provides benefits for industry such as better process understanding, fewer batch failures, more predictable clinical outcomes, cost savings, and opportunities for reduced regulatory submissions and technology transfer.

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    QbD Part1

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    Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with defined objectives and emphasizes product and process understanding based on sound science and quality risk management. The key objectives of QbD are to achieve product quality specifications based on clinical performance, increase product development and manufacturing efficiency, enhance root cause analysis and post-approval change management, and increase regulatory compliance. QbD provides benefits for industry such as better process understanding, fewer batch failures, more predictable clinical outcomes, cost savings, and opportunities for reduced regulatory submissions and technology transfer.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    8 views2 pages

    QBD Part1

    Uploaded by

    Abhay Deulkar
    Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with defined objectives and emphasizes product and process understanding based on sound science and quality risk management. The key objectives of QbD are to achieve product quality specifications based on clinical performance, increase product development and manufacturing efficiency, enhance root cause analysis and post-approval change management, and increase regulatory compliance. QbD provides benefits for industry such as better process understanding, fewer batch failures, more predictable clinical outcomes, cost savings, and opportunities for reduced regulatory submissions and technology transfer.

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    © All Rights Reserved
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    of 2

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