Quality Featured Articles

  1. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

    The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

  2. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

    Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

  3. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

  4. 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.

  5. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

    Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

  6. Building A High-Fidelity Manual Baseline For Tomorrow's Automated Inspection 7/14/2025

    Future-proof your pharma manufacturing. Discover why manual visual inspection remains foundational and how advanced software can build a high-fidelity baseline for automation success.

  7. 6 Things To Consider During Visual Inspection Operations 7/14/2025

    Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.

  8. How Software-Enabled Manual Visual Inspection Can Boost Your ROI 7/14/2025

    Unlock hidden cost savings in pharma manufacturing. Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

  9. Nitrosamine Testing For Regulatory Readiness 7/8/2025

    Discover how delivering ultra-sensitive detection of nitrosamine impurities like NDMA and NDEA helps safeguard pharmaceutical quality and meet evolving global regulatory demands.

  10. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

    Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.