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
Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software
Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. By Dr. D. Dixon, University of Ulster
Biological Contamination Management In Aseptic Environments: Requirements And Expectations
Bio-contamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources. By James Drinkwater
Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry
As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments
Pharmaceutical Manufacturing: The Challenge Of Setting Effective Product Specifications
Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments
Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.