Quality Featured Articles

  1. USP <1207> Updates Leak Testing Recommendations for Pharma Companies

    Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

  2. Materials Characterization In Pharma

    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.

  3. Using Microcurrent High Voltage Leak Detection Technologies For Challenging Drug Products

    Using HVLD in the the pharmaceutical industry - leveraging test method development on some products to validate other products.

  4. Innovative Robotic Handling For Pre-filled Syringes

    Addressing the challenge of implementing an inspection method to automate testing pre-filled syringes in a nested tray.

  5. Elemental Impurities: Steering Clear Of The Big Four

    With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.

  6. Optical Rotation And Quality Control

    The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

  7. Excipients And SAXS: The Detection Of Structural Aging

    A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.

  8. Maintaining Data Integrity With Inspection Software

    It may sound like just another pharma and life sciences industry buzzword, but “Data Integrity” is as important as computer system validation when products get released to market. 

  9. The Role Of Packaging In Supply Chain Management

    In order to achieve a successful supply chain management, packaging systems have to be connected with aspects of marketing, logistics, productions, and the environment.

  10. Business and Cultural Considerations When Managing Clinical Supplies for Asia-Pacific Studies

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.