Validation, Commissioning & Design Featured Articles

  1. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

    Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

  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. Sterile Contract Manufacturing Selection: Aligning CGMP With Precise Product Requirements 6/30/2025

    Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

  4. Regulatory Compliance And Audits For Parenteral Manufacturing Precision 6/30/2025

    CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

  5. 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. 

  6. 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.

  7. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

    CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

  8. 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.

  9. How A Rigorous Approach Delivers Unparalleled Results 6/12/2025

    In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.

  10. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.