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
Can Manufacturing Challenge QC On Viscosity Measurement?
The current batch of skin cream lotion seems ok to the eye. It has the same feel and appearance as all the other batches produced earlier in the week.
A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward
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