Risk Management Featured Articles

  1. Survey Says: Comfort Improves Safety (Part 1 of 4) 8/6/2013

    Between May and June 2013, fifty-three (53) laboratory managers and professionals were polled on LinkedIn to gauge the importance of the correlation between comfort and safety. Of those respondents, 49 (92%) indicated that comfort does increase laboratory safety. By Brian Garrett, LEED Green Associate, Product Manager

  2. The Answer To Final Pack Off Containment 2/27/2007

    The DoverPac® continuous liner system provides the advantage of replacing packs without breaking containment, unlike using inflatable heads or having operators shuffle tube stock.

  3. Flexible Containment Solutions Guide: Mill Containment System - Jet Mills

    The process for this application consists of the controlled feeding of a mill through a feeder. The powder is introduced into the feeder using a drum transfer system.

  4. 9 Steps To Remember When Performing A Supply Chain Risk Assessment

    This article provides practical tools for creating a risk assessment procedure related to Good Distribution Practice (GDP) guidelines.

  5. 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.

  6. Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs

    The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high speed lines have been designed to supply the patients with “multipurpose” small molecules drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer. By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group

  7. 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.

  8. 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.

  9. 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

  10. 7 Things You Need To Know About Biopharmaceutical Powder Charging With Flexibles

    Alan George is the Product Manager for ILC Dover’s flexible containment and disposable systems and has been actively supporting the development of flexible containment solutions for a wide range of processing equipment for over 13 years. In this Q&A, Alan responds to 7 questions concerning the use of flexibles to support powder charging in biopharmaceutical operations.