Quality Featured Articles

  1. Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues 1/8/2021

    The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

  2. Six Serialization Mistakes Pharmaceutical Companies Make 12/21/2020

    This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project and proposes a solution to avoid each of these issues.

  3. Implementing Improved Analytical Methods To Support Vaccine Quality 12/18/2020

    Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.

  4. Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices 3/2/2020

    This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

  5. Experimental Methods For Microorganism Challenges On OWBA 2/17/2020

    While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

  6. USP <1207> Updates Leak Testing Recommendations For Pharma Companies 10/2/2018

    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.

  7. 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.

  8. How To Leverage Microcurrent High Voltage Leak Detection Technologies 7/16/2018

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

  9. Innovative Robotic Handling For Pre-filled Syringes 7/12/2018

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

  10. Maintaining Data Integrity With Inspection Software 2/23/2018

    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.