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  • 2222 Product Development - Flowchart

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    Bojja Ramesh
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    The document outlines a 21 stage product development flow chart for new pharmaceutical products. It begins with literature searches and sourcing active ingredients. It progresses through evaluation, purchasing, testing, and manufacturing process development of active ingredients and other components. Later stages include process optimization, scale-up activities, pivotal batch production, and regulatory submission processes such as ANDA filing and validations.

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    The document outlines a 21 stage product development flow chart for new pharmaceutical products. It begins with literature searches and sourcing active ingredients. It progresses through evaluation, purchasing, testing, and manufacturing process development of active ingredients and other components. Later stages include process optimization, scale-up activities, pivotal batch production, and regulatory submission processes such as ANDA filing and validations.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pptx, pdf, or txt
    21 views4 pages

    2222 Product Development - Flowchart

    Uploaded by

    Bojja Ramesh
    The document outlines a 21 stage product development flow chart for new pharmaceutical products. It begins with literature searches and sourcing active ingredients. It progresses through evaluation, purchasing, testing, and manufacturing process development of active ingredients and other components. Later stages include process optimization, scale-up activities, pivotal batch production, and regulatory submission processes such as ANDA filing and validations.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
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    Download as pptx, pdf, or txt
    of 4

    PRODUCT DEVELOPMENT

    FLOW CHART
    STAGE 1
    Literature STAGE 2 STAGE 3
    Search Active Sourcing Active Evaluation

    STAGE 6
    STAGE 5 STAGE 4
    Innovator Product
    Active testing Active Purchasing
    Purchasing

    STAGE 7 STAGE 8 STAGE 9


    Innovator Product Bulk Active Excipient
    Testing Testing Evaluation
    STAGE 11
    STAGE 10 STAGE 12
    Manufacturing
    Container Closure Bulk Active
    Process
    System Choices Purchase
    Evaluation

    STAGE 14
    STAGE 13
    STAGE 15. Process
    Analytical
    SCALE - UP Optimization
    Evaluation
    PO Batch

    STAGE 17 STAGE 18
    STAGE 16
    Pivotal Batch ANDA Pre-
    Process
    Production submission
    Qualification
    AUDIT
    19B STAGE 20
    STAGE 19A
    Product Process Validation &
    ANDA
    Development Statistics
    SUBMISSION
    Report (3 commercial lots)

    STAGE 21
    Process Revalidation
    after a major change
    (Check SUPAC)

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