Quality by Design Featured Articles

  1. Critical Opportunity For Pharmaceutical And Process Understanding

    Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.

  2. Porosity And Its Influence On Pharmaceutical Tablet Dissolution Profiles

    Drug delivery as solid dosage forms is complex with a number of factors that can noticeably influence their therapeutic benefit. The drug must be stabilized in the tablet and at the same time be available for absorption in a short time after dosing [1]. The formulation and design of soluble oral tablets needs several factors to be considered.

  3. Materials Characterization In Pharma

    R&D spending in the pharmaceutical industry through 2015 was valued at around $58bn as organisations vied to gain a competitive advantage by bringing new drugs to market as quickly as possible. 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. The pharma industry is increasingly embracing the principles of Quality by Design (QbD) to improve efficiency and ensure good quality and reduced variability throughout the drug production process.

  4. Physical Properties Tests For The Pharmaceutical Engineer

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

  5. 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.

  6. 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.

  7. The Impact Of Waste On The Cost Of Quality In The Pharma Industry

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

  8. 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.

  9. How To Increase Regulatory Flexibility And Tablet Production Efficiency

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

  10. 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.