Quality Featured Articles

  1. 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.

  2. 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.

  3. 5 Key Principles Of Cleanroom Particle Counting 6/24/2025

    Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

  4. ISO Cleanroom Standards 6/24/2025

    Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

  5. Cleanroom Data Analytics For Setting Up Environmental Monitoring 6/24/2025

    Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing

  6. What Is OPC Counting Efficiency? 6/24/2025

    Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

  7. How Particle Counting Efficiency Affects Distribution Data 6/24/2025

    Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.

  8. AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence 6/23/2025

    Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

  9. The Benefits Of Low Endotoxin Products 6/16/2025

    Minimizing endotoxin contamination is vital in pharmaceutical manufacturing to protect patients from harmful reactions. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.

  10. Raw Material Considerations For Cell Therapies 6/16/2025

    For cell therapy developers, selecting appropriate raw materials is a significant challenge. Examine key considerations for mitigating risk and aligning with current regulatory expectations.