FDA plays an important role in clarifying the regulatory frameworks for innovative manufacturing techniques, identifying supply chain gaps and challenges to improve resilience. It’s important to develop an effective control strategy for continuous manufacturing and consider unexpected and expected variations and transient disturbances in input material attributes, process conditions, or environmental factors over time during normal operation. This session will discuss: 

• Adopting and harmonising key technical and regulatory considerations and including certain cGMP to continuous manufacturing. Regulatory guidelines – ICH’s Q13

• Understanding challenges related to legacy equipment, including line shutdowns and lack of flexibility for shorter production runs and line changeover 

• Assessing an effective control strategy for a continuous mode of operation to mitigate the risk of potential disturbances to product quality

• Defining efficient engineering and management of pharmaceutical plants for optimal integration of engineering and operations

Data-driven processes can make production not only smarter, but more agile and reliable. It’s important to assess flexible automation systems that are easy to integrate and set up and it’s been predicted that pharmaceutical companies are going to be spending more on capital equipment in the next 12-24 months. Embedded into this spend is the necessity for the next generation of processing. This session will address: 

• Better forecasting and tracking of production lines, detection of manufacturing bottlenecks and making recommendations for adjustments to improve accuracy. 

• Monitoring risks to manufacturing production, such as unplanned downtime or delays

Continuous manufacturing presents a paradigm shift in drug production and meets the pharmaceutical industry’s demands for faster product development, reduced costs, improved production economics and increased flexibility. This session will aim to address and discuss: 

• Implementing a fully integrated and closely controlled process that gives excellent product consistency by intrinsic design

• Taking a collaborative approach to continuous pharmaceutical manufacturing

• Understanding how PAT, combined with automated control platforms, is also key to successfully implementing fully integrated continuous manufacturing

On the whole, the pharmaceutical manufacturing industry loses about $50 billion a year because of the general inefficiency of batch processing — whether it’s due to time constraints, shipping losses, contamination, or the expense of a recall. This session will address: 

• Assessing the advantages of continuous manufacturing over batch manufacturing; include the availability and use of real-time data to accelerate manufacturing scale-up and help improve medicine quality 

• The advantages of embracing the concept of continuous manufacturing, control strategies and approaches to process validation as well as scale-up and stability

• Understanding how to bridge existing batch manufacturing process to a continuous manufacturing process