Analytical QbD at Teva: Knowledge Is Power Only When You Share It
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
WHITE PAPERS & CASE STUDIES
Determination Of Cell Aggregation In Bacteria Cultures With An Automatic And Reliable Method
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as Electrical Sensing Zone (ESZ) technique. The ISO International Standard 13319 describes this technique. By Andres Lobeiras, Product Manager, Beckman Coulter, Inc
Safe And Effective Filtration In Containment
In containment, it is essential that airflow must match the filter rated flow used in the system. By Russ Krainiak And Ronnie Harris
Supply Chain Management Is The Key To Growth For Pharmaceutical And Medical Device Manufacturers
It has been said that ‘demographics are destiny,’ and this is certainly true of the global growth of the middle class. Newly empowered consumers around the world are creating dynamic and expanding new markets for products that promise to sustain and improve the quality of their lives. International trade has become particularly important for pharmaceutical and medical device manufacturers because 57 percent of demand is now found outside of North America. Foreign markets are also manifesting the fastest growth. Yet less than one percent of U.S. healthcare companies export3. What factors hinder pharmaceutical and medical device organizations from participating in the large and growing global marketplace? Many companies cite two primary concerns as the impediment to taking their businesses beyond a solely domestic focus. By Scott Szwast, Healthcare Segment Marketing Director, UPS
How To Eliminate Heat Effect In Your Fume Hoods
Chemical procedures commonly require the introduction of heat. This is typically in the form of a hot plate or open flame. While the best place to perform these types of chemical procedures is inside a chemical fume hood, most people are unaware of heat’s effect on the airflow through the fume hood, and the potential impact on containment. By Luke Savage, LEED Green Associate, Sales Engineer, Labconco Corporation
Water Purity And Lab Glassware Washers: Just How "Pure" Does It Have To Be?
Water purity supplied to a laboratory glassware washer for rinsing has been the subject of debate in regards to the end result of producing clean glassware. It should be noted that the term ‘deionized water’ does not reference any specific water purity level. The deionization of water produces water within a wide range of purity levels. The deionization process can be used to make medium grade water at 10-20 microsiemens of conductivity, or, it can be used in polishing systems to produce water with a 16-18 megohm resistivity level. By Bob Applequist, Labconco Product Manager
Why Are My Freeze Dry Flasks Breaking? 4 Pre-Freezing Tips
After 15 years of telling customers not to fill their freeze dry flasks to the rim, and not to place their freeze dry flask straight up and down in the freezer, and not to put the lids on their freeze dry flasks during pre-freezing, guess what I did? By Jenny Sprung, Product Manager