Risk Management 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. Fast-Tracking A QbD Approach
    12/28/2017

    QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed. 

  3. How To Use QbD Software To Improve An Existing Identification Method
    11/15/2017

    What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.

  4. Solving The OOS Problem With Continuous Manufacturing
    8/13/2017

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  5. Viral Safety Approaches For Advanced Therapy Medicinal Products
    7/11/2017

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

  6. Critical Opportunity For Pharmaceutical And Process Understanding
    4/28/2017

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

  7. 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.

  8. 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.

  9. 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. 

  10. 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.