Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month.
The incorporation of statistical evaluations and scientific approaches supports the biopharma world in developing successful process validation techniques. The world of biopharmaceuticals is advancing along with the process knowledge and understanding of manufacturers. Learn more about these cutting-edge developments and biopharma innovation.
GMP bioprocessing includes crucial attributes that must actively be monitored and controlled during observation and process validation. The Continued Process verification plan aims to eliminate risks in production and to increase regulatory approval. See the primary points that influence bioprocess and new parameters on the market.
Buket has been involved with ISPE since her time in college at Istanbul University. While pursuing her skills and interest in pharmaceuticals, she stayed connected to ISPE through the Turkey Affiliate’s efforts to increase pharmaceutical knowledge and opportunity. Find out how ISPE membership can further both career and personal development.
“WFI production is a critical part of any parenteral drug process. There are several factors that need to be considered when selecting WFI production methods, such as capacity, future needs, storage, and quality control.” Discover water for injection innovations with this technology overview.
The objective for this introductory blog is for members of the pharmaceutical community to share their direct to patient quality experiences, learnings, and questions while ensuring that concerns and recommendations are met. Explore the models that will improve the patient experience.
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...