Many Life Sciences companies are exploring what it might take to move closer to implementing an automated real-time batch release approach. Real-time release (RTR) has been envisioned for around 20 years. The FDA put out its guidance on Process Analytical Technology approaches, which includes RTR, in September of 2004. Real-time batch release is based on monitoring Critical Parameters defined in the Quality by Design (QbD) control plan, using principles outlined for Process Analytical Technology (PAT). RTR is triggered if everything goes to plan and the batch record doesn't need manual reviewing to release it.
Automated real-time release however, is another beast entirely. Automated RTR utilizes advanced digital tools, such as Advanced Industrial Analytics, AI/ML, and Robotic Process Automation (RPA), to achieve a "Review by Exception" approach to batch review and release activities.
Several significant benefits make Automated RTR worth pursuing, such as:
• Improved quality of Products.
• Dramatically reduced finished product inventory levels.
• Reduced manual labor across labs, quality, and supply chain.
Some pharmaceutical companies have achieved RTR, but the lift to get there has been significant. Moreover, the maintenance of older, legacy systems supporting RTR is not trivial.
In this Research Spotlight we delve into Real-Time Automated Batch Release to examine:
🔸 Five of the top challenges to the realization of real-time release.
🔸 Solutions to overcome these challenges and make RTR a Reality, including the four categories of action to focus on.
🔸 The critical role Analytics plays in RTR.
Moreover, we provide actionable recommendations for manufacturers to start moving the needle toward RTR today.
Download the full Research spotlight below.