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.
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.
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.
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.
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.
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.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...