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Review ArticleReview

A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages

Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
Ajay Babu Pazhayattil
1Pharmaceutical Management Consultant, 565 Doan's Ridge Road, Welland ON L3B 5N7, Canada;
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  • For correspondence: ajpazha@gmail.com
Naheed Sayeed-Desta
2Sanofi Pasteur, 1755 Steeles Avenue W, North York, ON M2R 3T4, Canada;
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Shu Chen
3Apotex Inc., 150 Signet Drive, Toronto ON M9L 1T9, Canada; and
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Marzena Ingram
4Eurofins Alphora Research Inc., 2450 Bristol Circle, Oakville, ON L6H 6P6, Canada.
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References

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    International Conference for Harmonisation, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
  2. 2.↵
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    U.S. Food and Drug Administration, Guidance for Industry: Process Validation: General Principles and Practices. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2011.
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    U.S. Food and Drug Administration, Pharmaceutical cGMP's for the 21st century-A Risk-Based Approach. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
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    Parenteral Drug Association Inc. Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations; Bethesda, MD, 2012.
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    The Risk of Trusting Risk Priority Numbers, AAPS Newsmagazine, Feb 2017. https://www.aapsnewsmagazine.org/aapsnewsmagazine/articles/2017/feb17/cover-story-feb17 (accessed January 1, 2019)
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    U.S. Food and Drug Administration, Guidance for Industry: SUPAC: Manufacturing Equipment Addendum. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2011.
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    Quality Risk Management. FDA Advisory Committee of the Office of Pharmaceutical Science Manufacturing Subcommittee, July 20, 2004.
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    International Conference for Harmonisation, Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH: Geneva, 2017.
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen, Marzena Ingram
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 423-434; DOI: 10.5731/pdajpst.2019.010173

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A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen, Marzena Ingram
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 423-434; DOI: 10.5731/pdajpst.2019.010173
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  • Article
    • Abstract
    • Introduction
    • Scope Determination and Product/Process Review
    • CQA Identification
    • Material Attribute/Process Parameter Identification
    • Material Attributes/Process Parameters Classification and Risk Factor Assignment
    • Computing Risk Ratio and Constructing Risk Assessment Charts
    • Potential Applications
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More in this TOC Section

  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

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  • Pharmaceutical quality systems
  • Validation

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