Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month.
Explore the innovative software that will change the future of bioprocess planning and data collection. The bioprocess digital twin is a mathematical model that utilizes current manufacturing data and can better predict process chain outcomes.
Process verification and validation methods are crucial for any organization’s success with today’s complex supplies and equipment. See how continued process verification can help the industry avoid challenges and optimize the potential for regulatory compliance.
Hear from Robert Beall as he shares why process validation and the lifecycle approach are critically important for reliable manufacturing, product sustainability, and quality assurance.
Read about key details to new CT application, timelines, and requirements for the application process of EU clinical trials. Updates and additional information for the EU Clinical Trial Regulation are featured in this article.
Discover the impact of cutting-edge technologies, new production methods, and the latest advancements towards the future of biopharmaceutical manufacturing. This article highlights topics discussed at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston.
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...