Data, Process Control & Accountability for Contract Pharmaceutical Manufacturing

How data management protects your reputation & contractual obligations

The Iqvia Institute for Human Data Science estimates that the pharmaceutical sector will grow from around 1.5 trillion USD in 2023 to at least 1.9 trillion USD within four years. By any measure, the sector is phenomenally successful. It is led by many of the world’s largest and most innovative companies that exploit the power of emerging technologies and new scientific discoveries to benefit people around the world.

The success of the pharmaceutical sector fundamentally depends on the trust that patients and consumers place in the drug products that they use. And trust depends on the safety of these products, which in turn require meticulously managed production operations.

Drug safety, GMP & contract manufacturing

This is where GMP – Good Manufacturing Practice – plays a critical role. GMP was introduced following a number of healthcare scandals in the nineteen fifties and sixties, where unregulated production and testing of drug products adversely affected the health of patients and, in some cases, contributed to early deaths.

GMP is now mandated and regulated by national and international government and healthcare bodies around the world. It is designed to help pharmaceutical companies control their manufacturing operations and the quality of the products they supply. An effective GMP implementation requires careful design of each phase of the production and testing process, combined with accurate and completely reliable monitoring systems. These generate the critical data on which to base decisions for process optimization and, most importantly, to prove that the entire operation and thus the quality and safety of the finished drug products comply with the appropriate regulations.

For contract pharmaceutical manufacturers, this ability to generate, analyze and report on the safety and compliance of their production operations is especially critical. Failure at any stage of production will potentially result in a loss of reputation, the withdrawal of business, and the risk of severe financial penalties if the contract manufacturer is deemed to have breached its customer contract.

Real-time monitoring data management at the process level

Modern pharmaceutical contract manufacturing operations are inherently complex. In particular, monitoring and control data needs to be gathered, collated and analyzed in real-time from multiple reference points across the process and then fed back into process control, alarm, and optimization systems. It also needs to be available in different forms for use by production operators and managers as part of quality control and traceability protocols.

This is where platforms such as our modular Rotronic Monitoring System (RMS) can play a vital role. The Rotronic RMS has been designed from the ground up to enable pharmaceutical contract manufacturers to demonstrate compliance with regulated production operations. It incorporates GAMP5 category 4 software and category 1 hardware to enable contract manufacturers to monitor GxP-compliant applications, with a focus on the key quality attributes and process parameters that are required to prove product quality, data integrity and compliance with both EudraLex EU Annex 11 and FDA CFR 21 Part 11. 

The Rotronic RMS can be configured for either on-site data storage or SaaS-validated cloud-based data access, in an ISO27001-certified data center. In each case, the system interconnects to a process network of wireless or hard-wired data loggers and sensors for monitoring a range of critical process parameters including temperature, humidity, differential pressure and particles. Integration with third-party devices is straightforward, using analog or MODBUS TCP connections, while a separate API allows external systems to easily extract and interrogate data.

Protecting your interests

The continued growth of the pharmaceutical sector is creating fresh opportunities for contract manufacturers. Indeed, according to the research specialists MarketsandMarkets the contract pharmaceutical manufacturing sector will grow by 7.9% (CAGR), growing from 176.5 billion USD in 2023 to reach over 258 billion USD by 2028. With these opportunities, however, will come even greater demands from across the sector for contract manufacturers to meet tougher regulatory standards while minimizing output costs and improving production efficiencies without affecting product quality. Each of these criteria requires a greater ability to monitor, measure and control each stage of production operations, with data management and the use of precision, modular and completely reliable monitoring systems being critical to the success of this process.

Learn more!

Learn how our modular Rotronic monitoring system can enhance pharmaceutical contract manufacturing:

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Sources

Iqvia Institute
MarketsandMarkets