Beyond compliance: The business case for real-time process monitoring in Pharma

Advances in real-time process monitoring are enabling pharmaceutical companies to achieve fewer recalls and greater resilience in an increasingly competitive market. NIRAS supports pharmaceutical companies making the shift towards continuous monitoring within Process Analytical Technology (PAT) procedures. Adopting these measures improves operational efficiency and mitigates the risks and costs associated with recalls and retroactive process optimizations.

This article discusses the shortcomings of focusing solely on compliance and highlights how real-time process monitoring can help companies achieve Pharma 4.0 objectives, deliver higher product quality, speed up development, and build more robust operations.

The limits of compliance-only monitoring

Sampling is an essential component of pharmaceutical manufacturing. However, the methods used can introduce inefficiencies into monitoring practices, which can lead to crucial deviations being missed. Intermittent sampling involves removing Active Pharmaceutical Ingredients (API) from the production line and testing them at regular intervals, or testing only once the production run is complete. This leaves gaps in monitoring throughout batch production, creating opportunities for deviations to reach the finishing and formulation steps unnoticed (2). Offline lab-based testing provides a snapshot of process analytics and cannot capture the complex dynamics of the production process.

These approaches lead to diminished production efficiency, as well as potential shortcomings in product quality. Identifying excursions at the end of a batch reduces the time available for engineers to implement corrective measures. These systems can lead to manual bottlenecks as samples must be removed to a laboratory space for processing by a human operator. This slows production and limits the ability of companies to expand their operations. Over time, and as regulatory recommendations evolve, using these processes will lead to greater scrutiny, particularly as more modern methods, such as Continued Process Verification (CPV) and Quality by Design (QbD), become more widely adopted (3,4). 
With this in mind, it’s essential to acknowledge that a shift in operations toward continuous oversight, which enables proactive correction, is a superior approach that protects both companies and patients.

What Real Time process analytics looks like today

ICH 6A guidelines recommend the implementation of new technologies where possible to improve quality assurance (QA)5. Technological advances have made real-time process analytics possible, allowing immediate data capture and proactive decision-making, in contrast to traditional retrospective reviews caused by fragmented testing schedules and post-hoc analyses. AI is playing an increased role in process analytics, providing (6):

•    Integration and analysis of diverse data types, such as real-time Raman spectroscopy and mass spectrometry data.
•    Advanced predictive capabilities for deviations and machine failure enabled by modeling and digital twins.
•    Insights from large volumes of historical process data.

Sensor networks are enabling robust oversight of various production parameters and Critical Quality Attributes (CQAs), giving engineers more control over the process and enabling rapid responses to deviations (7). Robotics is helping to replace the need for manual input and provides consistent 24-hour capabilities (8). Importantly, these approaches are not about generating extra data to support the QA process. Instead, they provide data that is representative of process dynamics, allowing engineers to adapt their production strategies proactively and ensure uninterrupted production. 

The strategic business case: 5 Tangible benefits

Businesses can reap lasting benefits by adopting real-time process monitoring. Let’s examine five core benefits businesses can expect when adopting these approaches.

1. Proactive quality monitoring

Real-time monitoring enables companies to detect anomalies in real-time before they accrue into significant deviations. This means that processes can be stopped early, allowing researchers to conserve resources for future runs that might otherwise be wasted. Real-time analyses serve as an additional layer of QA and security, providing researchers with peace of mind that the process is within regulatory guidelines. This helps to safeguard against the risk of non-compliance and allows researchers to quantify yield improvements and waste reductions in their processes more accurately.

2. Operational efficiency and predictive maintenance

Real-time insights enable researchers to make adjustments to their processes, potentially saving entire batches that would otherwise fall outside of compliance. Even in situations where the quality of the end product is not at risk, researchers can still optimize their processes to improve throughput and reduce waste. Optimizations are more easily achieved with real-time information than with retrospective action. Predictive alerts generated from analytical information help to mitigate the risks and expenses associated with unplanned downtime, allowing researchers to avoid operational inefficiencies and plan around unavoidable interruptions. In-line QA reduces the need for lengthy testing after batch completion.  

3. Accelerated Time-to-Market

Real-time process monitoring insulates drug development processes from setbacks that delay time-to-market. Concurrent testing ensures that deviations are identified early and can be corrected without the need to reestablish entire processes or purchase additional raw materials. While many roadblocks in drug development are unavoidable, real-time monitoring provides businesses with a head start in overcoming them by offering earlier access to more representative data. Newer drug modalities, which require more personalized processes, are likely to benefit even more from real-time monitoring, as process deviations carry a relatively higher cost and the margins for error are significantly smaller. New or less mature production lines benefit from real-time adjustments, which help accelerate both development and manufacturing.

4. Cost mitigation

Real-time process monitoring minimizes the expense associated with recalls, fines, and the need for repeated QA and QC processes. Furthermore, real-time in-line processes reduce the need for staff to be present on the production line or in the laboratory performing analytical testing. This frees up highly skilled staff to work on process optimizations and research. Prioritizing staff for high-value tasks provides further benefits, as processes are optimized earlier and focus can shift toward continued innovation rather than tedious manual work.

5. Stakeholder trust

Real-time analyses enable continuous process improvement and stronger audit trails, as any deviations and subsequent adjustments are automatically recorded. By providing an extra layer of QA, real-time process monitoring reduces the likelihood of deviations and ensures that non-compliant products do not reach patients. Higher quality bolsters business credibility with regulatory bodies, partners, and patients, protecting businesses from reputational damage incurred by recalls and missed deadlines.

Together, these benefits are likely to increase revenue and organizational resiliency while ensuring that regulatory expectations are met and exceeded.

From assessment to intelligent automation

NIRAS offers comprehensive end-to-end IT and automation consulting services for pharmaceutical companies seeking to modernize their processes in line with Industry 4.0 (8,9). NIRAS has broad expertise across the pharmaceutical production process, from research and discovery to maintaining compliance post-approval. Our team’s expertise spans IT, automation, project management, and compliance, helping early adopters navigate 21 CFR Part 11, Eudralex Vol. 4 Annex 11, GAMP5, and GDPR compliance with confidence. Core NIRAS solutions include:

• Implementation and support: Specialist guidance and support for establishing automated systems within production lines and ensuring ongoing operational efficiency.
• Legacy system review: Ensuring that new systems can integrate data from legacy systems and maintain smooth interoperability.
• Supplier audit and control: Expert-led assessments of supplier performance and alignment with internal documentation standards.
• Project management: PMP, SCRUM, IPMA(C), and Agile-certified project managers provide expert oversight to ensure operational success.
• Change management: Adaptive solutions for changing regulatory requirements to provide ongoing compliance.
  

Conclusion

Real-time process monitoring transforms compliance from a mere requirement into a driver of better business outcomes. By overcoming manual bottlenecks and delayed responsiveness to deviations, companies can proactively safeguard product quality, boost efficiency, and gain a competitive edge. NIRAS helps pharmaceutical companies move from concept to implementation, ensuring that systems are future-ready and compliant.

Contact our team today to unlock tangible business value through smarter, real-time process control. 

References

1.    Research C for DE and. Report on the State of Pharmaceutical Quality. FDA. Published online October 6, 2024. Accessed June 19, 2025. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/report-state-pharmaceutical-quality

2.    Romañach R. Sampling in pharmaceutical manufacturing: a critical business case element. Spectrosc Europe. Published online October 12, 2021:67. doi:10.1255/sew.2021.a49

3.    Research C for DE and. Guidances | Drugs. FDA. January 17, 2025. Accessed June 20, 2025. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

4.    Yu LX, Amidon G, Khan MA, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):771-783. doi:10.1208/s12248-014-9598-3

5.    ICH Official web site : ICH. Accessed March 14, 2025. https://www.ich.org/page/quality-guidelines

6.    Manzano T, Whitford W. Artificial Intelligence Empowering Process Analytical Technology and Continued Process Verification in Biotechnology. GEN Biotechnology. 2025;4(1):23-28. doi:10.1089/genbio.2024.0041

7.    Asachi M, Alonso Camargo-Valero M. Multi-sensors data fusion for monitoring of powdered and granule products: Current status and future perspectives. Advanced Powder Technology. 2023;34(7):104055. doi:10.1016/j.apt.2023.104055

8.    Wasalathanthri DP, Shah R, Ding J, Leone A, Li ZJ. Process analytics 4.0: A paradigm shift in rapid analytics for biologics development. Biotechnol Progress. Published online May 31, 2021. doi:10.1002/btpr.3177

9.    Pharma 4.0 Operating Model | Industry 4.0 | ISPE | International Society for Pharmaceutical Engineering. Accessed June 20, 2025. https://ispe.org/initiatives/pharma-4.0