Insights On Regulatory Compliance

31. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

    Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

32. What Is The Biggest Problem With Inspector Training And Qualification? 8/25/2025

    Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.

33. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

34. Molecular Approaches To Streamline Cell Therapy Product Analytical Testing 9/26/2025

    Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

35. Safeguarding Quality In Parenteral Drug Manufacturing 10/16/2025

    Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

36. FAQs On The Revised EU GMP Annex 1: Volume 7 2/4/2026

    Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

37. How LIMS Supports QC Scaling At Forge Biologics 1/21/2026

    Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

38. Enhancing Automated Environmental Monitoring In Gloveless Isolators 1/7/2026

    Explore how automation and robotic-friendly solutions are transforming fill-and-finish operations and gain insights into gloveless processes, EM testing challenges, and collaborative innovations.

39. GMP Compliance For Pharmaceuticals And Medical Devices 3/14/2025

    Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.

40. 5 Trends Impacting CMOs In 2025 2/4/2025

    In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.