INSIGHTS ON QUALITY CONTROL

• Digitalizing Pharma Control Strategies: A Roadmap

  Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

• Contamination Control Strategy With QRM Principles

  Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

• The Importance Of Having A Strong Reject Characterization Program

  Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.

• Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance

  Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

• Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity

  6/19/2024

  Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

• A Powerful Non-Destructive Tool For Tablet Characterization

  10/6/2025

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• Particle Data Collection And Interpretation For ISO Cleanrooms

  3/19/2026

  Transition from periodic sampling to continuous monitoring. Learn to establish risk-based alert limits and use N:M trending to maintain a true state of control in critical cleanroom zones.

• Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2

  12/27/2024

  Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

• Leachables Method Development, Validation And Relevant ICH References

  5/16/2025

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.