January 2008 Issue


  • Embracing Risk

    As we move ahead as an industry, transforming our concept of quality to align with the latest FDA and international regulations, we find ourselves in uncharted waters. The dilemma of implementing Quality by Design (QbD), Risk-Based Validation (RBV) and Process Analytical Technology (PAT) has challenged traditional quality thinking.

  • Driving Change in an Era of Shifting Industry Dynamics

    Pharmatech’s Bikash Chatterjee notes that more companies are taking a more scientific approach to quality systems, and applying Lean Six Sigma and other concepts earlier in the drug development process. In addition, concepts like OEE are becoming far more widely used.

  • Personalized Medicine: The Future Is (Almost) Now

    The move away from the blockbuster model toward ever more narrowly targeted therapeutics is slowly but surely in progress, promising to transform not just drugmaking, but the entire healthcare system.

  • The Ups and Downs of Taking the Bus: Part Two

    In Part 2 of this series, Wyeth's Gary Forrest illuminated the processes of commissioning and qualifying a new bioprocess facility's fieldbus-based process control system and addresses life cycle management issues.

  • Moving Beyond the Batch

    Cost savings, FDA endorsement and the willingness of drug manufacturers to collaborate to find new methods might facilitate the move to continuous processing.

  • Upfront: FDA/Conformia Report CRADA Progress

    FDA and Conformia’s CRADA team reports that its next joint workshop on ICH, the first of several that will be held this year, will take place on February 20 and 21 in the D.C. area. The team will receive its 2007 Pharmaceutical Manufacturing Team of the Year award at the workshop. It is being recognized for its efforts to break down communication barriers within industry, FDA, and between the two groups, to streamline and improve drug development.