Risk Management Featured Articles

  1. What Is Combustible Dust?

    At present there is no universal definition for combustible dust. The OSHA NEP defines it as “particulate solid that presents a fire or deflagration hazard when suspended in air or some other oxidizing medium over a range of concentrations, regardless of particle size or shape.”

  2. Lean Six Sigma: Six Steps To Successful Implementation

    A focus on Lean Six Sigma manufacturing is instrumental to this company’s strategy for future growth and success.

  3. 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

  4. Quality Management: How Much Are Vendors To Blame?

    Biopharmaceutical manufacturing is one of the most demanding industries on its suppliers: demanding that its vendors be prequalified as primary or secondary, requiring confirmations of product provenance, certificates of analysis, and other sometimes onerous documentation. All of this is done for drug product quality and consistency.

  5. Best Practices For Designing Cell-Based cGMP Facilities

    CGMP regulations incorporate the concept of quality by design (QbD). This concept is used in conjunction with a quality management system (QMS) aimed at controlling the collection, processing, storage, and release of human medicinal products.

  6. 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.

  7. 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

  8. 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.