Smart Manufacturing for Pharmaceuticals

Smart manufacturing in the pharmaceutical industry emphasizes the importance of a comprehensive digital twin and a cybersecure IT/OT convergence to seamlessly connect information and operations and leverages analytics, AI, machine learning, the Internet of Things (IoT), edge computing, and the cloud.

Key imperatives for adopting smart manufacturing include:

• Agile process and plant engineering to accelerate start-up time and optimize plant layout and flow
• Flexible and paperless manufacturing to adopt modular production and produce right first time, from personalized medicine to high-volume batch and continuous production
• Intelligent, lean and sustainable operations to shift to adaptive and autonomous operations and meet evolving production goals

Smart manufacturing improves pharmaceutical production by giving companies the ability to quickly adapt to changing market demands without compromising quality and use digitalization to ensure regulatory compliance while also increasing production agility and cost efficiency.

Smart manufacturing enhances the readiness, efficiency, and responsiveness of your operations.

With digitalization in pharmaceutical manufacturing, pharma companies can achieve:

• 30-50% reduction in deviations
• 30-50% increase in labor productivity
• Up to 40% increase in plant capacity
• 15-20% reduction in lead time
• 10-15% reduction in conversion cost

Regulatory affairs in the pharmaceutical industry ensure that companies comply with all legal and regulatory requirements in the countries where they are marketed and includes the necessity for information behind the development, manufacturing, approval and marketing processes of the pharmaceutical product.

Regulatory affairs include any number of government agencies, application processes, or oversight committees receiving the documents and data that proves compliance.

Navigating the complex and ever-changing regulatory landscape can be difficult. Siemens is helping companies ensure their products meet stringent safety and efficacy standards set by regulatory bodies like the FDA and EMA by using modern and advanced technologies, such as digital twin and AI.

Smart manufacturing makes it easier and more efficient to handle regulatory constraints for increasingly diverse and complex product portfolios. It enables real-time data acquisition, monitoring and control to ensure quality and regulatory compliance. The integration of automation systems with higher-level platforms such as MES and ERP can also help achieve streamlined operations and compliance with stringent regulatory requirements.

Smart manufacturing can help companies move from automated production to adaptive, predictive and autonomous operations with the help of advanced technologies using analytics, artificial intelligence, machine learning, IoT, edge computing, and the cloud.

Other technologies for smart manufacturing include standardization, modular automation, and virtual validation, which can minimize start-up time and reduce commissioning time. Process Analytical Technology (PAT) can be used to increase quality control efficiency and reduce QC costs by enabling real-time release.

Finally, the digital twin allows you to combine the real and digital worlds for both product and processes. Being able to deploy high-fidelity digital twins of the manufacturing processes using real-time monitoring and real-time data integration allows for continuous improvement, data control, failure prevention and field trial reduction.