Scribd Logo
Upload

Welcome to Scribd!

  • 76 views

    Process Characterization: DOE Design Space Fmea

    Uploaded by

    Sam Perakis
    This document discusses process characterization techniques including failure mode and effects analysis (FMEA), design of experiments (DOE), and design space definition. It explains that critical quality attributes (CQAs) are properties that must be controlled to ensure safety and performance, and critical process parameters (CPPs) must be controlled to meet CQAs. The document provides an example of using techniques like risk analysis, design space characterization, and setting operating ranges to control parameters like pH, bed height, and flow rate during a reverse phase column process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content

    You might also like

    Process Characterization: DOE Design Space Fmea

    Uploaded by

    Sam Perakis
    76 views26 pages
    This document discusses process characterization techniques including failure mode and effects analysis (FMEA), design of experiments (DOE), and design space definition. It explains that critical quality attributes (CQAs) are properties that must be controlled to ensure safety and performance, and critical process parameters (CPPs) must be controlled to meet CQAs. The document provides an example of using techniques like risk analysis, design space characterization, and setting operating ranges to control parameters like pH, bed height, and flow rate during a reverse phase column process.

    Original Description:

    Original Title

    QbD2023

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document discusses process characterization techniques including failure mode and effects analysis (FMEA), design of experiments (DOE), and design space definition. It explains that critical quality attributes (CQAs) are properties that must be controlled to ensure safety and performance, and critical process parameters (CPPs) must be controlled to meet CQAs. The document provides an example of using techniques like risk analysis, design space characterization, and setting operating ranges to control parameters like pH, bed height, and flow rate during a reverse phase column process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    76 views26 pages

    Process Characterization: DOE Design Space Fmea

    Uploaded by

    Sam Perakis
    This document discusses process characterization techniques including failure mode and effects analysis (FMEA), design of experiments (DOE), and design space definition. It explains that critical quality attributes (CQAs) are properties that must be controlled to ensure safety and performance, and critical process parameters (CPPs) must be controlled to meet CQAs. The document provides an example of using techniques like risk analysis, design space characterization, and setting operating ranges to control parameters like pH, bed height, and flow rate during a reverse phase column process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 26

    Process Characterization

    FMEA DOE Design Space

    Risk Analysis Characterize and Optimize Definition


    Design Space
    Characterization Range

    Acceptable Range

    Operating Range

    Set Point

    Design Space
    European Medicines Agency
    CQA
    • Quality Attributes
    – A physical, chemical, or microbiological property or
    characteristic of a material that directly or indirectly impacts
    quality
    • Critical Quality Attributes (CQAs)
    – A quality attribute that must be controlled within predefined
    limits to ensure that the product meets its intended safety,
    efficacy, stability and performance
    • Critical Process Parameters (CPPs)
    – A process parameter that must be controlled within
    predefined limits to ensure the product meets its pre-defined
    quality attributes

    Moheb M. Nasr, Ph.D.


    Office of New Drug Quality Assessment (ONDQA), OPS, CDER
    CQA

    (1-10 ppm)
    2nd
    3rd
    Detergent Removal
    Case Study 3.3 - RP Column
    Case Study 3.3
    • Reverse Phase Column
    – Product related variants and HCP
    • Risk Analysis – parameters
    – pH
    – Bed height
    – Column load
    – Temperature
    – Resin type
    – Flow rate
    Design Space
    Characterization Range

    Acceptable Range

    Operating Range

    Set Point

    Design Space

    You might also like