Quality by Design Featured Articles

  1. Analytical QbD at Teva: Knowledge Is Power Only When You Share It 7/3/2014

    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.

  2. Human Error Is The Leading Cause Of GMP Deviations – Or Is It? 5/1/2014

    Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick.  Every company wrestles with human error.  We know humans have error rates – we’re not perfect.  But how many is too many?

  3. Out With The Old, In With The New: GSK's Smart Workplace 2/24/2014

    By eliminating the confines of the traditional workspace, companies can encourage better employee interaction and collaboration. Will this be the key for an industry counting on innovation to lead it into the future?

  4. Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  5. Defining Holistic Asset Criticality To Manage Risk In Biopharma

    This article presents how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.

  6. Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka