Quality by Design Featured Articles

  1. 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. Creams and ointments, for example, are filled into tubes and jars; the effort needed to extract them from their container and spread on skin is the appropriate test. 

  2. 3 Development Principles Of Advanced Biopharmaceutical Tubing
    10/14/2016

    Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. Advancements associated with tubing may not necessarily be perceived as revolutionary, but there is an ability to innovate in this space. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the three development principles in this article should take place.

  3. An Introduction To Biopharmaceutical Facility Design & Layout
    6/23/2016

    This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

  4. The Impact Of Waste On The Cost Of Quality In The Pharmaceutical 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. As a consultant with many years of experience in the industry, I’ve observed the negative effects of waste at many companies, and I want to identify activities that can be defined as “wasteful.”

  5. Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    5/20/2016

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

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

    The goal of every pharmaceutical developer is to create quality products which generate consumer satisfaction, require low cost, and have low risk. Quality starts from the moment of conception of an idea and continues throughout production.

  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

    After a decade of cost cutting in product development and manufacturing, many pharmaceutical companies have struggled to meet basic quality standards. In recent years, the U.S. Food and Drug Administration (FDA) has shuttered numerous manufacturing sites and banned a variety of products because of Good Manufacturing Practices (GMP) violations. As a result, many companies have experienced substantial hits to both their corporate reputation and profitability.

  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.