Decoding Quality Risk Management & ICH Q9 In Pharma Industry

by Andrea Urciuolo, GMP Compliance Advisor at PQE Group

Understanding Quality Risk Management 

Risk management is a widely practiced approach across various business sectors, aimed at reducing and mitigating the potential and actual impacts of unpredictable events, as well as capitalizing on opportunities. Quality Risk Management (QRM), on the other hand, is a structured approach aimed at identifying and managing quality-related risks in the pharmaceutical industry, where product quality directly impacts consumer health and safety, through thorough evaluation and assessment. With QRM, pharmaceutical companies can identify potential quality issues that might harm consumers before they occur, assess a product's overall impact on patient health, and implement strategies to mitigate these risks. This makes Quality Risk Management a key approach not only for achieving regulatory compliance but also for establishing and embedding a proactive approach to risk management within a pharmaceutical organization's culture.

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Since 2005, when the guidelines on Quality Risk Management were introduced, ICH Q guidelines have gradually expanded to encompass various aspects of pharmaceutical quality assurance and control. Now, with the latest ICH Q9(R1) guideline, there is an opportunity for the industry to once again focus on the importance of Quality Risk Management (QRM) in pharmaceutical production, reinforcing the principles established over the years and providing updated guidance to adapt to evolving challenges and technologies in the industry. 


ICH Q9’s Role In Quality Risk Management 

The International Conference on Harmonisation's (ICH) Quality Risk Management (QRM) guideline, ICH Q9(R1), is designed to safeguard the quality of pharmaceutical products across their entire lifecycle by identifying and mitigating risks. The updated guideline emphasizes the importance of protecting patient safety by advocating for the systematic assessment, control, and management of risks. Pharmaceutical organizations are encouraged to make informed, risk-based decisions grounded in scientific knowledge to comply with regulatory standards. This approach not only ensures consumer health and safety but also aligns with regulatory expectations, reinforcing the commitment of the pharmaceutical industry to uphold high-quality standards and practices. 


ICH Q9’s Impact on Organizational Culture and Decision Making 

Quality Risk Management (QRM) in pharmaceuticals, as guided by ICH Q9(R1), adopts a scientific approach. While the industry has historically mixed scientific methods with internal risk management practices, ICH Q9(R1) advocates for using recognized tools like Failure Mode Effects Analysis (FMEA), Failure Mode, Effects and Criticality Analysis (FMECA), Fault Tree Analysis (FTA) and Hazard Analysis and Critical Control Points (HACCP). These tools aim to systematically manage quality risks through thorough evaluations, promoting a proactive approach to safeguard product quality and patient safety by basing decisions on scientific evidence and risk management best practices. According to this guideline, decision-making within QRM should be risk-based to enable effective management of quality risks.  

While this guideline dictates that the level of formality should be determined taking into account elements such as uncertainty, importance, and complexity, the approach to decision-making should always aim to manage risk by utilizing empirical evidence and the available knowledge to make informed decisions. While totally eradicating bias is impossible, minimizing subjectivity should be a priority in Quality Risk Management to ensure biases have a minimum influence on the entire process, while striving to maintain the integrity and objectivity of risk assessments to improve patient safety and product quality. By applying the appropriate QRM tools with clearly defined risk questions and risk scoring scales, pharmaceutical organizations can significantly reduce subjectivity within their risk management procedures as highlighted in the latest ICH Q9(R1) update. 


Mitigating Product Shortages & Manufacturing Issues With QRM 

Quality Risk Management plays a crucial role in tackling product availability issues stemming from quality and manufacturing problems, such as GMP non-compliance which often leads to product shortages. Using QRM and knowledge management, pharmaceutical companies can proactively identify and address potential risks, implement preventive measures, and ensure continuous supply chain robustness, ultimately safeguarding the availability of essential medicinal products to meet patient needs. As supply chains become more complex, it becomes vital to address the challenges that come with globalization by integrating technology to enhance supply chain resilience and mitigate risks associated with increased interdependencies and potential disruptions.  


Quality Risk Management As An Ongoing Strategy 

By adopting a systematic Quality Risk Management (QRM) approach, pharmaceutical organizations can benefit from improved decision-making. This helps them better allocate resources, prioritize patient safety, and ensure the consistent supply and quality of pharmaceutical products. As QRM principles become embedded into a company's culture, it fosters an environment of continuous improvement, risk awareness, and proactive management. This cultural shift not only enhances operational efficiency and compliance with regulatory standards but also strengthens the organization's ability to respond to challenges and opportunities in the dynamic pharmaceutical landscape. Through the integration of QRM across all levels of operation, companies can achieve a holistic understanding of the risks associated with their products and processes, leading to more informed and strategic decisions that support their mission to deliver safe and effective healthcare solutions. 

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