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;
Naheed Sayeed-Desta
2Sanofi Pasteur, 1755 Steeles Avenue W, North York, ON M2R 3T4, Canada;
Shu Chen
3Apotex Inc., 150 Signet Drive, Toronto ON M9L 1T9, Canada; and
Marzena Ingram
4Eurofins Alphora Research Inc., 2450 Bristol Circle, Oakville, ON L6H 6P6, Canada.

References
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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
Jump to section
- 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
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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