Reduced cost: Proactively addressing risks through digital integration can prevent costly deviations and product recalls. By optimizing and stabilizing processes, businesses can reduce the likelihood of errors, waste, and rework, leading to overall cost savings.
One way is to use automated data collection and analysis tools to monitor the process and detect deviations from the expected performance. This can help identify potential issues early on and prevent them from becoming bigger problems.
Here’s an example: During early-stage development, R&D identifies that a specific critical quality attribute (CQA-12) has been affected by a particular critical process parameter (CPP-18). As a control strategy, the team defines a range in which the process parameter needs to be controlled to ensure that the effect remains within the specification.
Continuous improvement culture: Digital technology can foster a culture of continuous improvement that encourages automatic feedback loops between risk assessment findings and CPV results. We can use insights from CPV to refine and enhance risk assessments, leading to a more robust and adaptive quality management system.
Optimized processes: By combining risk assessment with CPV, organizations can pinpoint opportunities for process improvement. Continuous data monitoring and analysis can optimize critical process parameters, increasing efficiency and reducing variability.
Interconnected ecosystem: Integration across different organizational departments and functions will increase. This interconnected ecosystem could involve the seamless flow of data between risk management, quality assurance, production, and supply chain management, providing a holistic view of the entire value chain.
Summary
Digital twins for simulation and optimization: Digital twins, virtual replicas of physical processes, can be employed for simulation and optimization. This technology allows businesses to model and analyze various scenarios, optimizing CPV and risk assessment strategies before implementing changes in the actual production environment.
Digital technology can improve the integration of risk assessment and CPV in many ways.
Additionally, IoT devices can collect data in real time and provide insights into the process. This can help identify any issues as they arise and allow for immediate corrective action.
In this article, we focus on the potential of developing risk assessment and CPV as digital technologies and integrating them to unleash the full power of data.
Narrowing the divide
Data centralization: We can leverage digital technology to integrate data from risk assessments and CPV activities. A centralized data management system helps us track and analyze relevant information, giving us a more comprehensive understanding of the performance of ongoing processes in the context of identified risks.
Increased automation in decision-making: Automated decision-making processes based on real-time data analysis will likely become more sophisticated. This includes automating responses to deviations and risks, reducing the reliance on manual intervention and ensuring faster and more accurate decision-making.
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients, the business, and compliance, CPV involves monitoring and analyzing manufacturing processes to ensure they remain in a state of control. CPV also helps to identify and prevent deviations, ensuring product quality and compliance.
Scenario 2: The developmental risk assessment exercise is executed via a digital solution. With connectivity between risk assessment and CPV, the knowledge about CPP-18 and CQA-12 is available in a seamless flow. This ensures that the team sees everything that must be evaluated during CPV.
Enhanced compliance: Digital integration enables real-time monitoring and documentation of CPV and risk assessment data. This facilitates compliance with regulatory requirements because businesses can provide transparent and comprehensive records of their processes, helping them meet regulatory standards and guidelines.
Internet of things (IoT) integration: IoT devices will play a significant role in capturing real-time data from various points in the manufacturing process. IoT integration allows for a more comprehensive understanding of CPV, enabling proactive risk management and immediate response to deviations.
Efficient decision-making: Digital integration provides a platform for real-time data analysis, allowing for quick decision-making based on accurate and up-to-date information. This enables businesses to respond promptly to emerging risks and deviations, minimizing the impact on operations and product quality.
And finally, blockchain technology can be used to create a secure and transparent record of the process, improving accountability and traceability.
Advanced analytics and artificial intelligence (AI): The use of advanced analytics and AI algorithms will likely become more powerful in digital risk assessment and CPV. Predictive analytics can anticipate potential risks and deviations, while machine learning algorithms can optimize processes using historical data. Ultimately, these advancements will lead to more robust and efficient operations.
Blockchain for traceability: Blockchain technology may be increasingly adopted to enhance traceability in digital risk assessment and CPV. The decentralized and immutable nature of blockchain can provide a secure and transparent record of data, facilitating more accessible audit trails and compliance verification.
Scenario 1: The developmental risk assessment exercise is executed on paper-based records. During routine CPV, the team at the manufacturing location misses evaluating CPP-18 and observes an unexpected trend of CQA-12 across all batches manufactured from Stage II to the current evaluation of Stage III. Unfortunately, the site team has no idea what’s causing this trend.
Collaborative teams: Collaboration via digital technology can break down silos of information and promote a holistic understanding of the processes, enabling a more unified approach to managing risks and verifying process performance.
Greater traceability: Digital integration provides a comprehensive CPV and risk-assessment data record throughout production. This enhances traceability, making it easier to investigate and address any issues that may arise while also supporting quality assurance efforts.
Risk-based decision-making: Risk assessment can be a foundation for making decisions about CPV activities’ frequency and intensity. By prioritizing CPPs identified through risk assessment, we can focus our CPV efforts on these critical areas to ensure ongoing process control.
Another way is by using emerging technologies such as AI and machine learning to analyze large amounts of data and identify patterns that might not be immediately apparent to humans. This can help improve risk assessment accuracy and ensure that the process runs smoothly.
Integrating risk assessment with critical process variables in a digital framework can offer several business benefits.
Documentation and reporting: Digital technology eliminates effort and errors in manual documentation and reporting procedures. The resultant transparency aids in demonstrating the interconnectedness of these activities during audits and inspections.
What integration does for business
Common language and metrics: Digital technology can ensure that a common language and metrics are used across both risk assessment and CPV activities. This can facilitate communication and understanding among the various stakeholders, leading to more effective collaboration.
By integrating technology, we can unite risk assessment and CPV functions to achieve higher data integrity and quality standards in the biopharmaceutical industry. Although each serves a distinct purpose, technology helps align and integrate these functions to enhance the overall efficiency of operations.
Competitive advantage: Companies that digitally integrate risk assessment with CPV can gain a competitive advantage by demonstrating a commitment to quality, compliance, and efficiency. This can be a key differentiator in the pharmaceutical industry, where product quality and process reliability are paramount.
The future of integrated risk assessment and CPV
Here are ways in which the divide between risk assessment and CPV can be narrowed using digital technology.
Periodic review of risk assessments: Digital technology ensures that risk assessment is dynamic and reflects the current process status. This helps to align CPV activities with the most up-to-date risk profile.
Improved product quality: By combining risk assessment with critical process variables, organizations can identify and address potential risks that could affect product quality. This ensures that CPPs are controlled within specified limits, leading to a more consistent and higher-quality end product.
Integrated approach: Digital technology can foster an integrated approach to quality management that considers risk assessment and CPV as complementary components. Establish a framework that seamlessly connects risk assessment findings with the design and execution of the CPV strategy.
Both risk assessment and CPV are critical to quality, operations, and compliance. Both use large amounts of product knowledge and process data, yet the industry appears to have missed the connection between the two. One reason could be that risk assessment and CPV are still manual and independent processes in most pharmaceutical companies. Yet both data sets are connected, and risk assessment data are an important subset of CPV at a granular risk level.
The devastating affect of disconnection
The future will likely be characterized by greater advancements in technology, increased automation, and a keener focus on real-time decision-making. Here are some trends and developments that could shape the future of this integration.
Businesses that invest in cutting-edge technologies to drive an integrated approach to quality will likely benefit from improved efficiency, higher product quality, and a competitive edge in the marketplace.