Control strategies are the backbone of product quality in the pharmaceutical industry, especially as regulatory expectations intensify. To remain compliant, efficient, and consistent, many manufacturers are turning to digital tools to enhance their control strategy process. By digitalizing, you not only streamline manufacturing but also achieve greater process control, reduce time to market, and ensure data transparency and integrity.
Here’s a roadmap to make the digital shift in your control strategy within the context of chemistry, manufacturing and controls (CMC).
A control strategy, as defined by the ICH Q10 guidelines, is a “planned set of controls derived from a deep understanding of the product and its process, ensuring both quality and consistency.”
You should build your control strategy by applying a Quality by Design (QbD) framework.
Quality by Design is a foundational approach that builds quality into products rather than relying solely on final product quality control (QC) testing. Regulatory guidelines, especially ICH Q8 through ICH Q12, strongly encourage QbD, emphasizing that product quality arises from scientific understanding and rigorous risk management.
Integrating QbD into your control strategy helps you identify and control potential quality issues early, making your processes more robust and adaptable to digital transformation.
Quality by Design involves systematically designing processes to meet a quality target product profile (QTPP) by defining critical quality attributes (CQAs) and critical process parameters (CPPs) that ensure your product consistently achieves the expected quality outcome.
Here is a structured view of how QbD fits within a digital control strategy framework:
Defining the QTPP and identifying the CQAs and CPPs are part of an overarching process (see Figure 1 below) that ultimately should lead to the establishment of a process design space—a multivariate space where process parameters can vary within established limits while still yielding a product of desired quality. When defined digitally, the design space can be monitored in real time, allowing for adaptive controls and proactive responses to deviations to process behavior before they become a quality problem.
Figure 1: From QTTP to regulatory flexibility: a pathway to process excellence.
Digital QbD processes align well with modern control strategy goals by:
By combining QbD and digitalization, control strategies become more efficient and adaptive, ensuring consistency from development throughout commercial manufacturing while adhering to industry standards and regulatory requirements.
Traditionally, control strategies involve intensive manual work, data entry, and numerous quality checks. This approach is slow, and when there is for example, a departure from the controlled state, the resulting adjustments are reactive. Digital control strategies offer a proactive solution and several advantages over traditional methods, including:
These improvements translate to lower costs, fewer errors, and, most importantly, more consistent product quality.
Regulatory bodies like the FDA and EMA require comprehensive documentation and quality assurance across the product lifecycle.
Regulatory compliance remains a primary concern in pharmaceutical manufacturing, with control strategies playing an essential role in meeting stringent guidelines. The ICH Q10 guideline describes control strategies as structured sets of controls designed to ensure product quality. When integrated into a digital framework, these strategies not only streamline compliance efforts but also enhance traceability, documentation, and process control—all pivotal for regulatory adherence.
Once implemented, focus on ongoing performance monitoring and adjustments:
Continued process verification (CPV) is the third stage in process validation, focusing on ensuring that a process remains in control during its commercial phase.
Regulatory bodies, such as the FDA, emphasize CPV as a mechanism to confirm that manufacturing processes consistently yield quality products. This makes CPV a critical aspect of any control strategy, emphasizing the monitoring of process performance over time to ensure product quality remains within specifications.
Continued process verification enables ongoing verification of the CPPs and CQAs established during initial process design, which are part of the control strategy.
The data collected through CPV provides a feedback loop that informs adjustments to the control strategy, refining processes based on actual production data. This closed-loop approach aligns well with QbD, enhancing process understanding over time.
With a digital approach, CPV becomes more manageable, yielding insights for proactive adjustments rather than retrospective corrections.
A digital approach to CPV strengthens control strategies in several ways:
Integrating a digital CPV tool into a digital control strategy ensures that your process maintains a state of control, adapting to process variability as tit arises.
The two main advantages of integrating a digital CPV tool into the digital management of the control strategy are:
This approach helps sustain product quality throughout the product lifecycle, aligning with regulatory requirements and supporting efficient, data-driven process management.
Several digital technologies, combined with digital control strategies and digital CPV software, support maintaining a state of control in processes:
Digitalizing control strategies offers clear benefits, but it also presents challenges. Implementing a digital approach requires a shift in infrastructure, processes, and potentially company culture.
Here are some common challenges and solutions:
Adopting a digital control strategy is more than an operational upgrade; it’s a commitment to quality, compliance, and innovation in pharmaceutical manufacturing. Digitalizing control strategies transforms complex processes, enabling real-time monitoring, automated documentation, and seamless regulatory compliance.
By combining QbD, CPV, and data-integrated systems, digital control strategies shift the quality paradigm from reactive to proactive. This approach allows you to address risks early, maintain product consistency, and support continuous improvement.
Beyond meeting regulatory standards, digital control strategies provide a framework for efficiency, cost savings, and faster time-to-market. Real-time data insights, automated reporting, and an adaptive process design space empower you to manage every aspect of production with precision. By moving away from manual, paper-based systems, your team can focus on process optimization, reduce reliance on end-product testing, and pave the way for real-time release.
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