Validation, Commissioning & Design Featured Articles

1. 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. 

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns 6/3/2025

   In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

8. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

9. Ensure Safety And Compliance With A Guide To Sterilization Validation 5/28/2025

   Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. Explore essential principles, best practices, and frameworks for effective implementation.

10. Specific Sterilization Method: Best Practices And Common Pitfalls 5/28/2025

    Validating sterilization methods like steam, VH₂O₂, and EO is essential for safety and compliance. Learn best practices, avoid common pitfalls, and optimize your validation strategy effectively.