Quality by Design Featured Articles

  1. 3 Development Principles Of Advanced Biopharmaceutical Tubing

    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.

  2. An Introduction To Biopharmaceutical Facility Design & Layout

    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.

  3. The Impact Of Waste On The Cost Of Quality In The Pharmaceutical Industry

    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.”

  4. Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    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.

  5. How To Increase Regulatory Flexibility And Tablet Production Efficiency

    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.

  6. Managing QbD From A CMO Perspective

    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.

  7. Drug Shortages Highlight Quality Problems

    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. 

  8. Shifting Pharma’s Mindset: Viewing Quality As Value Creator, Not Cost

    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.

  9. The Impact of Well-Designed Weighing Processes On Product Quality

    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.

  10. Are Regulators Providing The Right Quality Incentives?

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.