Quality by Design Featured Articles

  1. Materials Characterization In Pharma 9/5/2018

    Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.

  2. Porosity And Its Influence On Pharmaceutical Tablet Dissolution Profiles 4/21/2017

    Porosity is a good prediction of how liquids enter into the tablet matrix, and the expectations can be validated by experiment. Dissolution rates do not exclusively depend upon porosity; other predictors are also valid including solubility, surface area, and particle size. In addition to carrying out dissolution testing, establishing porosity, surface area and other characteristics are key to establishing the optimal dissolution rate.

  3. The Utility Of Specific Surface Area Measurement For Pharmaceutical Materials 4/20/2017

    In the pharmaceutical world, particle size analysis has traditionally been the method of choice to “characterize” raw materials.

  4. Physical Properties Tests For The Pharmaceutical Engineer 2/23/2017

    Products packaged for consumer use by the pharma industry go through a battery of tests related to how the user applies the product. 

  5. The Impact Of Waste On The Cost Of Quality In The Pharma Industry 6/22/2016

    Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.

  6. How To Increase Regulatory Flexibility And Tablet Production Efficiency 8/5/2015

    The goal of every pharmaceutical developer is to create quality products that generate consumer satisfaction, require low cost, and have low risk.

  7. Managing QbD From A CMO Perspective 7/29/2015

    The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

  8. Drug Shortages Highlight Quality Problems 6/5/2015

    On the same day the Wall Street Journal published an article highlighting the issue of drug shortages in the US, CDER Director, Dr Janet Woodcock, delivered a keynote at the ISPE Quality Manufacturing Conference. Dr. Woodcock discussed initiatives by the FDA to overcome issues with manufacturing quality, a leading reason for drug shortages in the US. 

  9. Shifting Pharma's Mindset: Viewing Quality As Value Creator, Not Cost 5/14/2015

    The pharma industry is quickly, and fortunately, realizing that the value that quality creates can far outweigh the cost savings associated with not investing in it.

  10. The Impact of Well-Designed Weighing Processes On Product Quality 4/22/2015

    Companies involved in the production of pharmaceutical products are well aware of the importance of consistency and accuracy in manufacturing processes. Batches that fail quality inspections waste time, labor, effort, and resources. This further leads to a loss in profits and market reputation, as well as compromises human health and safety.