Validation, Commissioning & Design Featured Articles

1. A Comprehensive Guide To Sampling Protocols And Robust CCI Testing 1/5/2026

   Effective CCI testing hinges on strategic sampling and statistical rigor. Learn why 30 samples matter, how positive controls validate defect detection, and why risk assessment ensures long-term reliability.

2. Risk Management Across The Pharmaceutical Product Lifecycle 1/5/2026

   Managing risk throughout the pharmaceutical lifecycle requires proactive strategies. Explore advanced detection methods and rigorous sampling that ensure product integrity.

3. Conducting A CDMO Audit Day Efficiently: Practical Strategies 12/30/2025

   Efficient CDMO audits require strategic planning, clear communication, and real-time documentation to manage risks, avoid pitfalls, and strengthen compliance while protecting profitability and fostering collaborative partnerships.

4. Beyond Visual Inspection: Understanding Acoustical Transparency As A PAT 12/29/2025

   Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive approach enhances consistency, reduces risk, and ensures packaging integrity.

5. 9 Signs Your Pharma Operation Needs An Upgrade 12/22/2025

   Unplanned downtime, audit stress, and missed calibrations signal it’s time to rethink maintenance. Here are nine signs that your operation needs a modern EAM or CMMS to boost compliance and efficiency.

6. Supporting The Future Of cGMP Drug Product Manufacturing 12/22/2025

   Discover how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

7. Determining The Limit Of Detection In CCIT 12/18/2025

   Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.

8. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

   Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

9. Doubling Up For Speed In Biomanufacturing 12/12/2025

   Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

10. CDMO Or No CDMO... That Is The Question 12/12/2025

    Success depends on assessing internal capabilities and knowing when outsourcing can accelerate timelines. Learn how strategic decisions reduce risk, avoid costly delays, and keep your organization competitive.