Maintaining high standards of quality is crucial to ensure regulatory compliance and, consequently, patient safety.
The International Council for Harmonisation (ICH) plays a pivotal role in setting these standards, particularly through guidelines like ICH Q9, which focuses on quality risk management (QRM).
The recent revision, ICH Q9(R1), addresses previous shortcomings and introduces significant updates to improve the efficacy and clarity of QRM processes.
Understanding ICH Q9(R1)
The ICH Q9 guideline, first introduced in 2005, aimed to provide a systematic approach to QRM, facilitating consistent risk-based decisions across various stages of a product's lifecycle. Despite its foundational role, a few improvement areas were identified over time, necessitating a revision.
ICH Q9(R1), effective since July 2023, addresses key areas such as:
- Reducing the high levels of subjectivity in risk assessments and QRM outputs.
- Management of supply and product availability risks.
- Lack of understanding as to what constitutes formality in QRM work.
- Lack of clarity on risk-based decision-making.
Reducing Subjectivity
The new guideline emphasizes "hazard identification" over "risk identification" to better align with the risk assessment process.
Subjectivity can impact every stage of a quality risk management process, especially the identification of hazards and the estimation of the probability of occurrence and severity of harm. It can also impact the estimation of risk reduction and the effectiveness of decisions made from quality risk management activities. Subjectivity cannot be eliminated entirely but can be minimized by addressing bias and assumptions.
At ValGenesis, we recommend the following:
- Using software that can make risk management activities systematic. More than being systematic, it needs to streamline the risk operations of the entire organization.
- Installing a system that aggregates all the manufacturing data, processes it, and informs your QRM system of the real impact of your QRM activities. This will allow for the creation of new risks and the update of the existing ones.
Enabling this virtuous circle allows you to make QRM decisions that are science- and knowledge-based and thus less subjective.
Managing Supply and Product Availability Risks
Quality and manufacturing issues can lead to, product shortages.
ICH Q9(R1) highlights the importance of proactively identifying and implementing preventive measures that support product availability. Therefore, the following factors can affect supply and product availability and should be considered when applying QRM:
- Manufacturing process variability and state of control
- Manufacturing facilities and equipment
- Oversight of outsourced activities and suppliers
Enhancements include better monitoring systems to detect and manage supply chain issues that could affect product quality and availability. This is critical for maintaining manufacturing reliability and compliance with good manufacturing practices (GMP).
Formality in QRM Work
The updated guideline provides clearer guidance on the degree of formality required in QRM activities. This guidance aids in structuring QRM processes more effectively across different scenarios.
Quality risk management activities will have different degrees of formality depending on certain factors, such as:
- Uncertainty: lack of knowledge about hazards, harms, and, consequently, their associated risks.
- Importance: risk-based decision importance in relation to product quality.
- Complexity: the degree of complexity associated with the process or subject area.
Higher levels of uncertainty, importance, or complexity may require more formal quality risk management approaches to manage potential risks and support effective risk-based decision-making.
| Characteristics | Lower Levels of Formality | Higher Levels of Formality |
|---|---|---|
| QRM Process | One or more parts of the process are not performed as stand-alone activities but are addressed within other elements of the quality system. | All parts are explicitly performed. |
| QRM Tools | QRM tools might not be used in some or all parts of the process. | QRM tools are used in some or all parts of the process. |
| Team Involved | A cross-functional team might not be necessary. | A cross-functional team is assembled for the QRM activity. |
| Facilitator | N/A | Use of a facilitator with experience and knowledge of the quality risk management process may be integral to a higher formality process. |
| Reporting | Stand-alone quality risk management reports might not be generated. The outcome of the quality risk management process is usually documented in the relevant parts of the quality system. | Stand-alone quality risk management reports or related documents that address all aspects of the process may be generated and documented (e.g., within the quality system). |
Additionally, while importance and complexity are relatively straightforward to identify, uncertainty can be managed, up to a point, with a systematic approach for acquiring, analyzing, storing, and disseminating scientific information, which, in turn, will inform all QRM activities.
Therefore, at ValGenesis, we recommend setting up a system to perform this knowledge management to guarantee a better assessment of proper formality.
Risk-Based Decision-Making
A new subchapter has been added to focus on making risk-based decisions that are well-informed and based on standardized approaches. This includes utilizing robust knowledge management practices to support decision-making throughout a product's lifecycle.
Risk-based decision-making is implied in all quality risk management activities. They include decisions related to:
- The existing hazards.
- The risks associated with those hazards.
- The risk controls required.
- The acceptability of the residual risk after risk controls.
- The communication and review of quality risk management activities and outputs.
ICH Q9(R1) predicts three approaches to risk-based decision-making. These approaches are:
- Highly structured: This involves a formal analysis of the available options before making a decision and an in-depth consideration of relevant factors associated with them.
- Less structured: Simpler approaches are used to arrive at decisions, and they primarily use existing knowledge to support an assessment of hazards, risks, and any required risk controls.
- Rule-based: Standardized approaches, which do not require a new risk assessment to make such decisions, are typically based on previous risk assessments, which usually lead to predetermined actions and expected outcomes.
These approaches are adopted based on different levels of formality, which, in turn, are based on their levels of importance, complexity, and uncertainty of each decision.
| High Importance | Low Importance | |||
|---|---|---|---|---|
| Low complexity | High complexity | Low Complexity | High Complexity | |
| Low uncertainty | Less structured | Highly structured | Less structured | Highly structured |
| High uncertainty | Highly structured | Highly structured | Highly structured | Highly structured |
The Role of Quality Risk Management Software
To effectively comply with ICH Q9(R1), pharmaceutical companies must leverage advanced quality risk management software. Here’s why:
- Enhanced Risk Assessment Tools: Quality risk management software provides sophisticated tools for identifying risks and assessing hazards. These tools help systematically analyze risks based on the latest guidelines, reducing subjectivity and enhancing the accuracy of risk assessments.
- Improved Data Management: QRM software integrates various data sources and employs advanced analytics to provide a comprehensive view of potential risks. This ensures that all relevant data is considered in the risk assessment process, leading to more informed decisions.
- Automated Processes: The software ensures consistency and efficiency by automating routine QRM processes. This automation supports a high degree of formality and structure in risk assessments, as required by ICH Q9( R1), and enables robust control strategies aligned with Quality by Design (QbD) practices.
- Real-Time Monitoring and Reporting: Quality risk management software offers real-time monitoring capabilities, allowing for prompt detection and response to deviations in the manufacturing process or supply chain. This proactive approach is essential for managing supply and product availability risks effectively.
- Comprehensive Documentation: Keeping thorough and accurate documentation is crucial for regulatory compliance. Quality risk management software ensures that all QRM activities are well-documented, providing a clear audit trail that meets regulatory requirements.
- Integration with other Systems: Modern quality risk management software can integrate with other enterprise systems, such as ERP and MES, to provide a holistic view of the manufacturing process. This integration facilitates better risk-based decision-making by leveraging data from various sources.
Conclusion
The revision of the ICH Q9 guideline underscores the importance of robust quality risk management practices in the pharmaceutical industry.
As such, implementing a comprehensive quality risk management software solution is a strategic advantage. It enhances the accuracy of risk assessments, improves decision-making, and ensures compliance with the latest ICH Q9(R1) guidelines. As the industry continues to evolve, leveraging advanced digital tools for QRM will be essential for maintaining high quality and safety standards.
Using quality risk management software to guarantee ICH Q9(R1) compliance is a proactive step toward achieving excellence in pharmaceutical manufacturing. It ensures that all aspects of QRM are handled efficiently and effectively, paving the way for safer products and a more reliable supply chain.
About ValGenesis iRisk
ValGenesis iRisk is an advanced quality risk management platform designed for the pharmaceutical industry to ensure compliance with regulatory guidelines like ICH Q9(R1). It offers tools for systematic hazard identification, risk assessment, and risk-based decision-making. The platform integrates data from multiple sources, automates QRM processes, and provides real-time monitoring and comprehensive documentation. Its user-friendly dashboards and seamless integration with other enterprise systems support effective risk management and enhance overall manufacturing quality and safety.
For more details, visit the ValGenesis iRisk page.
