Read, Learn, Innovate: Top Blog Posts from September 2019
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from September 2019. Explore key insights for process innovation, distillation technologies, validation strategies, and more for what the pharmaceutical industry was reading last month.
Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner
Eli Lilly is the 2019 ISPE Facility of the Year Category Winner for Process Innovation for their IE2 Small Volume Continuous Facility located in Kinsale, County Cork, Ireland. See how they enabled the manufacturing of multiple steps of a drug substance process simultaneously to reduce the time required to bring medicine to the patient.
Is Your Validation Process Stuck in the Last Century?
Discover the impact of a fully electronic solution to issues with paper-based documentation of process validation procedures and outcomes. Sustainability of critical validation documents and the transformation to fully electronic databases are examined in this article.
Design Considerations for WFI Distillation Systems Part 1
This three-part technology overview delves into design considerations with different distillation methods and focuses on the latest available technologies, end-user perspective in facility design, and restrictions for product-specific manufacturing.
Continued Process Verification, 3rd Stage of FDA Process Validation Guidelines
Explore a plan for continued process verification and the crucial parameters and attributes necessary for successful GMP bioprocess. This plan at its core evaluates close attention to statistical accuracy and managing process vulnerabilities.
Common Pitfalls During Implementation of a Cleaning Validation Program
Hear from validation expert, Miguel Montalvo, on common challenges in implementing a successful cleaning validation program in facilities housing modernized equipment and medicines. This article features ten specific issues for cleaning validation that industry professionals can recognize and solve.
