January 2008 Issue
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.
MES is gaining ground in drug manufacturing, but adoption of QMS lags behind
Pharmatechs 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.
Hiring people who already know their jobs and will faithfully do them over and over will not get us to a working model of QbD.
Compressing force is a dynamic number recorded as the attempt to maintain two target values in close tolerance
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.
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.
Pseudo-empirical modeling of drug packaging conditions can save up to six months in getting pharmaceuticals to market.
Cost savings, FDA endorsement and the willingness of drug manufacturers to collaborate to find new methods might facilitate the move to continuous processing.
As competitive pressures reshape pharma, career and financial planning are becoming more important than ever.
Youre already applying operational excellence at work. Are you applying it to your own career planning and development?
FDA and Conformias 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.