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  • Quality by Design: CPOB 2018

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    Dita Harefa
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    This document outlines the steps for quality by design (QBD) pharmaceutical development which includes: 1) determining the quality target product profile (QTPP) and critical quality attributes (CQA), 2) initial studies to establish the formulation and process design and risk assessment, 3) formulation and process development using design of experiments (DoE), 4) defining the design space, 5) establishing a control strategy, and 6) continual improvement. The key aspects are linking material attributes and process parameters to CQAs through risk assessment and using DoE to develop the formulation and process within a defined design space.

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    4. QbD

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    This document outlines the steps for quality by design (QBD) pharmaceutical development which includes: 1) determining the quality target product profile (QTPP) and critical quality attributes (CQA), 2) initial studies to establish the formulation and process design and risk assessment, 3) formulation and process development using design of experiments (DoE), 4) defining the design space, 5) establishing a control strategy, and 6) continual improvement. The key aspects are linking material attributes and process parameters to CQAs through risk assessment and using DoE to develop the formulation and process within a defined design space.

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    © All Rights Reserved
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    11 views47 pages

    Quality by Design: CPOB 2018

    Uploaded by

    Dita Harefa
    This document outlines the steps for quality by design (QBD) pharmaceutical development which includes: 1) determining the quality target product profile (QTPP) and critical quality attributes (CQA), 2) initial studies to establish the formulation and process design and risk assessment, 3) formulation and process development using design of experiments (DoE), 4) defining the design space, 5) establishing a control strategy, and 6) continual improvement. The key aspects are linking material attributes and process parameters to CQAs through risk assessment and using DoE to develop the formulation and process within a defined design space.

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    © All Rights Reserved
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    of 47

    QUALITY BY DESIGN

    CPOB 2018
    GUIDANCE
    OBJECTIVE OF PHARMACEUTICAL DEVELOPMENT
    WHAT’S NEW USING QBD
    ICH Q8 DEFINITION OF QBD
    WHY NEED TO IMPLEMENTED QBD
    US/EU/PIC/S QBD REGULATORY TIMELINE
    CHANGE QUALITY PARADIGM
    PROCESS VALIDATION LIFECYCLE
    TAHAPAN QBD

    1. Penetapan Quality Target Product Profile (QTPP)


    2. Penentuan Critical Quality Atributes (CQA)
    3. Studi Awal
    a. Penetapan rancangan formula dan proses
    b. Risk assessment: link material attribute and process parameters to CQA
    4. Pengembangan Formula dan Proses à Design of Experiments (DoE)
    5. Penetapan Design Space
    6. Penetapan Control Strategy
    7. Continual improvement
    1. PENETAPAN QTPP
    `
    2. PENENTUAN CQA
    TAHAPAN QBD

    1. Penetapan Quality Target Product Profile (QTPP)


    2. Penentuan Critical Quality Atributes (CQA)
    3. Studi Awal
    a. Penetapan rancangan formula dan proses
    b. Risk assessment: link material attribute and process parameters to CQA
    4. Pengembangan Formula dan Proses à Design of Experiments (DoE)
    5. Penetapan Design Space
    6. Penetapan Control Strategy
    7. Continual improvement
    3. STUDI AWAL
    3.1.1 EVALUASI RLD_KOMPOSISI
    3.1.1 EVAL RLD_DRUG RELEASE
    3.1.2 STUDI BAHAN AKTIF
    3.1.2 STUDI BAHAN AKTIF
    3.1.3 STUDI EKSIPIEN
    3.1.4 STUDI ORIENTASI
    FORMULA
    3. STUDI AWAL
    TAHAPAN QBD

    1. Penetapan Quality Target Product Profile (QTPP)


    2. Penentuan Critical Quality Atributes (CQA)
    3. Studi Awal
    a. Penetapan rancangan formula dan proses
    b. Risk assessment: link material attribute and process parameters to CQA
    4. Pengembangan Formula dan Proses à Design of Experiments (DoE)
    5. Penetapan Design Space
    6. Penetapan Control Strategy
    7. Continual improvement
    3.2.1 RISK ASSESSMENT_DS ATTRIBUTES
    3.2.2 RISK ASSESSMENT_FORMULATION
    DOE 1_FORMULATION DEVELOPMENT (INTRAGRANULAR)
    DOE 2_FORMULATION DEVELOPMENT (EXTRAGRANULAR)
    UPDATED RISK ASSESSMENT OF THE FORMULATION
    PROCESS DEV.
    3.2.3 RISK ASSESSMENT_PROCESS
    TAHAPAN QBD

    1. Penetapan Quality Target Product Profile (QTPP)


    2. Penentuan Critical Quality Atributes (CQA)
    3. Studi Awal
    a. Penetapan rancangan formula dan proses
    b. Risk assessment: link material attribute and process parameters to CQA
    4. Pengembangan Formula dan Proses à Design of Experiments (DoE)
    5. Penetapan Design Space
    6. Penetapan Control Strategy
    7. Continual improvement
    NEXT STEP
    THANK YOU

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