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.
Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...