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.
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...