INSIGHTS ON REGULATORY COMPLIANCE

• The Role Of IV Bag Inspection In Drug Manufacturing

  Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.

• Why Compounding Pharma Manufacturers Should Evaluate BFS Systems

  Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.

• ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

  Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

• How Robotic Isolator Technology Aligns To Annex 1 Principles

  Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

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

  7/28/2025

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

• De-Risking The Transition From Vial To Drug-Device Combination Product

  7/25/2025

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• Navigating Cleanroom Compliance For Safe Material Transfer

  7/23/2024

  Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.

• From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPV

  7/3/2025

  Learn to leverage Continued Process Verification (CPV) and analytics for early detection of process drift, enabling preventive monitoring and enhancing overall process robustness.

• Accelerate Biologics Product Release With Seamless Viral Testing

  6/23/2025

  Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.