The availability and efficacy of pharmaceuticals to treat chronic and acute medical conditions is top of mind for the millions of people who rely on them daily, as well as the manufacturers that produce them, and the providers that prescribe them. 

However, recent data from the American Society of Health-System Pharmacists (ASHP) indicate significant annual drug shortages over the past five years, thereby impacting critical medications for cancer treatments and emergency drugs. Another survey released in October 2023 by nonprofit patient safety organization ECRI and its affiliate, the Institute for Safe Manufacturing Practices (ISMP), found that these shortages also extended to single-use supplies or other medical devices during the 6 months prior to the survey.

Current regulations acknowledge the potential for issues to arise during the production process, which are designed to identify and address any such issues prior to the final product’s release to the market. However, the prevalence of product recalls serves as a clear indicator that the existing ‘Product Release/Batch Release’ processes are failing to meet their intended objectives effectively.

Upon reviewing this process, The Futurum Group has identified that a significant portion of the industry continues to rely on manual procedures, which are inherently susceptible to human error. This reliance on outdated methods not only undermines the efficiency of quality control measures but also exacerbates the risk of non-compliance with regulatory standards.  

To address these concerns, the pharmaceutical industry needs to shift toward modern, efficient, and interconnected batch release systems. These systems should provide real-time tracking of ingredients, processes, and manufacturing steps, offering a holistic view of the supply chain, thereby ensuring product quality and consistency.

In this research brief, How Automated Batch Release Management Can Transform the Pharmaceutical and MedTech Industries and Enhance Patient Care, we address the challenges faced by pharmaceutical manufacturers with managing the batch release process, discuss the best practices for automating this process, and discuss SAP’s solution designed to specifically address these challenges.

In this brief you will learn about:

• The elements inherent in manual batch release processes that can negatively impact the quality and safety of pharmaceutical and medical devices
• The key components of a modern, efficient, and interconnected batch release system 
• The design elements, key capabilities, and future roadmap for SAP’s Batch Release Hub for Life Sciences solution
• The benefits of deploying SAP’s Batch Release Hub for Life Sciences to manufacturers, providers, and patients
• A key customer success story highlighting how the solution addressed their specific production needs

Download your copy of How Automated Batch Release Management Can Transform the Pharmaceutical and MedTech Industries and Enhance Patient Care to learn how to more efficiently and effectively manage the batch release process with assistance from SAP.