Insights On Quality Control

  1. Building A Connected Quality And Manufacturing Ecosystem In Life Sciences 12/27/2024

    Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

  2. Your Digital QC Companion For Sterility Testing 8/13/2024

    Discover software designed to ensure fully accurate data recording in sterility testing and that complies with 21 CFR Part 11 standards for electronic records and signatures.

  3. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

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

  4. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  5. Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles 8/8/2023

    As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

  6. Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres 12/30/2024

    Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

  7. Seamlessly Integrating An E-WorkBook With A Customer's LIMS 8/12/2024

    Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.

  8. Nitrosamine Impurities Deadline: Are Your Products Compliant? 11/6/2023

    The FDA nitrosamine contamination guidance set a deadline of August 1, 2025, for all drug manufacturers and market authorization holders to comply fully with the NDSRI limits set.

  9. The Problems With Construction Quality In Life Sciences 11/7/2023

    In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.

  10. Advancing Cell Therapy Manufacturing: Rapid Sterility Testing 5/7/2024

    The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.