Insights On Quality Assurance

  1. 5 Key Elements Of Quality By Design In Pharma 9/20/2024

    Learn about the advantages of embedding quality throughout design and manufacturing, explore five practical elements of QbD in pharmaceuticals, and discover how a QMS can support QbD.

  2. Aiming For Success In Early mAb Process Development And Beyond 7/15/2025

    Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

  3. Becton Dickinson: Enhancing Maintenance Compliance 8/8/2025

    Learn how BD standardized calibration across 85 sites with a RAM to boost compliance, efficiency, and system integration for scalable, future-ready operations.

  4. Real-Time Monitoring And Automated Sampling For Enhanced Efficiency 3/17/2025

    Integrating real-time, in-line monitoring with automated sampling in bioprocessing enhances efficiency and precision. Discover how advanced spectroscopy provides non-destructive insights to optimize cell growth and productivity.

  5. How Compounding Pharmacies Are Combating FDA Drug Shortages 9/26/2024

    Explore the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

  6. Your Environmental Monitoring Can't Be Your Only Line Of Defense 9/1/2025

    Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

  7. Compressed Gas Risk Assessment: A Significant Step In Your CCS 10/10/2024

    Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

  8. The Hidden Costs Of FDA Recalls: A QMS Guide To Prevention 1/28/2025

    Did you know that FDA recalls have increased 115% since 2018? Learn more on how to avoid common recall mistakes and effective recovery strategies for your company today.

  9. Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine 6/19/2024

    Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

  10. Container Closure Integrity Test Method Development For Autoinjectors 8/6/2025

    Discover an autoinjector technology that leverages laser-based headspace analysis for container closure integrity to advance biologic drug delivery with precision, safety, and regulatory confidence.