3 Trends I’m watching in Pharma Manufacturing Modernization
3 Trends
My name is Greta Pusch and I’m Director of Program Management for Teva’s Modernization & Digitalization Program in Manufacturing. These are the top 3 trends I’m watching in pharma manufacturing.
1: The integration of Information Technology (IT) and Operational Technology (OT) in Pharmaceutical Operations
Connecting leading edge software and systems to existing equipment, whether that’s manufacturing machines on the shop floor or lab equipment, is a trend we’re seeing in all sectors, not just in pharma.
The technology gives us access to better process data. The key is making that data easily accessible and actionable across our systems and workflows. For instance, real-time machine data can help us analyze our process performance, feed prediction models and power manufacturing yield dashboards. Ultimately, we want to use data to work smarter, stay competitive and enable our teams to make the best decisions at work every day.
We are using IT and OT to expand how we work. For example, we’re generating new algorithms, reports and dashboards to build more mature digital systems. As part of our modernization journey, we’re enhancing our diverse network and creating digital solutions to improve performance.
2: Data-driven pharma production
Digital transformation is a marathon; it requires strategic planning and a systematic approach to design and development, ensuring a smooth transition to implementation and deployment in the network.
An important approach we’re using at Teva is predictive modeling, which helps us analyze past data to predict future yields from manufacturing batches. For example, collecting data on compression force and speed helps us predict product quality and production yield, ensures we comply with our standards and effectively manage costs. These tools and insights enable us to optimize processes and deliver the best possible outcomes for our patients.
3: Artificial Intelligence (AI) in a best practice GMP environment
The integration of Artificial Intelligence (AI) within the pharmaceutical industry, particularly in the context of Good Manufacturing Practices (GMP), is rapidly transforming the landscape of drug development, manufacturing, and quality control. AI technologies, such as machine learning, predictive analytics and natural language processing, offer significant opportunities to enhance the efficiency, accuracy, and compliance of pharmaceutical operations while ensuring the highest standards of quality and safety.
In a GMP environment, AI plays a vital role in optimizing the entire manufacturing process, from raw material inspection and process control to final product testing. By analyzing large data sets generated throughout production, AI models can identify patterns, predict potential variations and recommend improvements in real time, enhancing compliance and improving overall product quality, as seen in Teva’s root-cause advisor tools.
AI-driven automation can also streamline documentation processes and is used in Teva’s report-generating AI applications. Further it can help ensuring real-time monitoring and audit trails for regulatory compliance. With the capability to continuously assess and validate processes, AI can provide manufacturers with deeper insights into process performance, facilitating data-driven decision-making.
While the potential benefit of AI in the pharmaceutical GMP environment is considerable, it must be implemented appropriately. Any AI system used in regulated environments must undergo thorough evaluation and be subject to rigorous testing to ensure it meets the necessary regulatory requirements. Additionally, human oversight remains essential to ensure AI-driven recommendations align with both compliance standards and ethical practices.
In summary, AI holds the potential to significantly enhance GMP compliance in the pharmaceutical industry by improving process efficiency, product quality, and regulatory adherence – ultimately advancing the delivery of quality medicines to patients.
Find out more
- Read more about the latest trends in pharma business development
