Date Log
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Role of Risk Management in Ensuring Quality and Safety of Bio- Pharmaceuticals
Corresponding Author(s) : Haya Mhanna
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 13 No. 2 (2025): 2025 Volume -13 - Issue 2
Abstract
Background: The biopharmaceutical industry faces significant risks that can compromise product quality and patient safety. These risks arise from the complexity of biopharmaceuticals and stringent regulatory requirements, necessitating effective risk management practices
Objectives: This study aims to evaluate the current state of risk management in the biopharmaceutical sector, identify challenges, and highlight the importance of integrating risk management throughout the product lifecycle.
Approach: A survey was conducted among industry stakeholders to gather insights on the adoption of risk management practices, the effectiveness of existing tools, and the perceived benefits and challenges associated with these practices
Results: The findings reveal that while 42% of respondents acknowledge the positive impact of risk management on product quality, 48% report difficulties in integrating these practices across various stages. Resource constraints, particularly for small and medium-sized enterprises (SMEs), were identified as a significant challenge
Conclusion: The study underscores the need for standardized frameworks, increased resource allocation, and enhanced collaboration among stakeholders to maximize the benefits of risk management in the biopharmaceutical industry. Addressing these challenges is crucial for improving patient safety and product quality.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
- ICH Q9: Quality Risk Management. (2005). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Woodcock, J., & Wosinska, M. (2013). Economic and technological drivers of generic sterile injectable drug shortages. Clinical Pharmacology & Therapeutics, 93(2), 170- 176.
- Kola, I., & Landis, J. (2004). Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery, 3(8), 711-716.
- Grabowski, H., & Wang, Y. R. (2006). The quantity and quality of pharmaceutical innovation. American Economic Review, 96(2), 14-18.
- Shankar, G., et al. (2015). Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations. The AAPS Journal, 17(1), 1-8.
- Rathore, A. S., & Winkle, H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology, 27(1), 26-34.
- Nasr, M. M. (2010). Quality by Design (QbD)—A modern system approach to pharmaceutical development and manufacturing. Pharmaceutical Engineering, 30(2), 1-4.
- Yu, L. X., et al. (2014). Understanding pharmaceutical quality by design. The AAPS Journal, 16(4), 771-783.
- FDA. (2011). Guidance for Industry: Process Validation: General Principles and Practices. U.S. Food and Drug Administration.
- EMA. (2013). Guideline on Risk Management Systems for Medicinal Products for Human Use. European Medicines Agency.
- FDA. (2004). Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Food and Drug Administration.
- ICH Q10: Pharmaceutical Quality System. (2008). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- FDA. (2019). Guidance for Industry: Quality Considerations for Continuous Manufacturing. U.S. Food and Drug Administration.
- EMA. (2015). Guideline on Good Pharmacovigilance Practices (GVP). European Medicines Agency.
- WHO. (2014). Guidelines on Quality Risk Management. World Health Organization.
- McKinsey & Company. (2020). Risk Management in the Pharmaceutical Industry: Challenges and Opportunities.
- Deloitte. (2019). Risk Management in Biopharmaceutical Manufacturing: A Holistic Approach.
- PwC. (2018). Pharmaceutical and Life Sciences Risk Management: Navigating a Complex Landscape.
- EY. (2021). Risk Management in the Biopharmaceutical Industry: Trends and Best Practices.
- BCG. (2020). The Future of Risk Management in Biopharmaceuticals.
- Rathore, A. S., & Mhatre, R. (2009). Quality by Design for Biopharmaceuticals: Principles and Case Studies. John Wiley & Sons.
- CMC Biotech Working Group. (2009). A-Mab: A Case Study in Bioprocess Development. CASSS.
- FDA. (2016). Case Study: Risk Management in Biopharmaceutical Manufacturing. U.S. Food and Drug Administration.
- EMA. (2017). Case Study: Risk-Based Approaches in Biopharmaceutical Quality Systems. European Medicines Agency.
- WHO. (2018). Case Study: Risk Management in Vaccine Production. World Health Organization.
- Gad, S. C. (2008). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons.
- Nally, J. D. (2007). Good Manufacturing Practices for Pharmaceuticals. CRC Press.
- Vesper, J. L. (2010). Risk Management in the Pharmaceutical Industry. Informa Healthcare.
- Nasr, M. M., & Rathore, A. S. (2015). Quality by Design for Biopharmaceutical Drug Product Development. Springer.
- Rathore, A. S., & Sofer, G. (2012). Process Validation in Manufacturing of Biopharmaceuticals. CRC Press.
References
ICH Q9: Quality Risk Management. (2005). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Woodcock, J., & Wosinska, M. (2013). Economic and technological drivers of generic sterile injectable drug shortages. Clinical Pharmacology & Therapeutics, 93(2), 170- 176.
Kola, I., & Landis, J. (2004). Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery, 3(8), 711-716.
Grabowski, H., & Wang, Y. R. (2006). The quantity and quality of pharmaceutical innovation. American Economic Review, 96(2), 14-18.
Shankar, G., et al. (2015). Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations. The AAPS Journal, 17(1), 1-8.
Rathore, A. S., & Winkle, H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology, 27(1), 26-34.
Nasr, M. M. (2010). Quality by Design (QbD)—A modern system approach to pharmaceutical development and manufacturing. Pharmaceutical Engineering, 30(2), 1-4.
Yu, L. X., et al. (2014). Understanding pharmaceutical quality by design. The AAPS Journal, 16(4), 771-783.
FDA. (2011). Guidance for Industry: Process Validation: General Principles and Practices. U.S. Food and Drug Administration.
EMA. (2013). Guideline on Risk Management Systems for Medicinal Products for Human Use. European Medicines Agency.
FDA. (2004). Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Food and Drug Administration.
ICH Q10: Pharmaceutical Quality System. (2008). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
FDA. (2019). Guidance for Industry: Quality Considerations for Continuous Manufacturing. U.S. Food and Drug Administration.
EMA. (2015). Guideline on Good Pharmacovigilance Practices (GVP). European Medicines Agency.
WHO. (2014). Guidelines on Quality Risk Management. World Health Organization.
McKinsey & Company. (2020). Risk Management in the Pharmaceutical Industry: Challenges and Opportunities.
Deloitte. (2019). Risk Management in Biopharmaceutical Manufacturing: A Holistic Approach.
PwC. (2018). Pharmaceutical and Life Sciences Risk Management: Navigating a Complex Landscape.
EY. (2021). Risk Management in the Biopharmaceutical Industry: Trends and Best Practices.
BCG. (2020). The Future of Risk Management in Biopharmaceuticals.
Rathore, A. S., & Mhatre, R. (2009). Quality by Design for Biopharmaceuticals: Principles and Case Studies. John Wiley & Sons.
CMC Biotech Working Group. (2009). A-Mab: A Case Study in Bioprocess Development. CASSS.
FDA. (2016). Case Study: Risk Management in Biopharmaceutical Manufacturing. U.S. Food and Drug Administration.
EMA. (2017). Case Study: Risk-Based Approaches in Biopharmaceutical Quality Systems. European Medicines Agency.
WHO. (2018). Case Study: Risk Management in Vaccine Production. World Health Organization.
Gad, S. C. (2008). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons.
Nally, J. D. (2007). Good Manufacturing Practices for Pharmaceuticals. CRC Press.
Vesper, J. L. (2010). Risk Management in the Pharmaceutical Industry. Informa Healthcare.
Nasr, M. M., & Rathore, A. S. (2015). Quality by Design for Biopharmaceutical Drug Product Development. Springer.
Rathore, A. S., & Sofer, G. (2012). Process Validation in Manufacturing of Biopharmaceuticals. CRC Press.