Insights On Quality Control

  1. 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.

  2. CMO Validation As A Service 8/20/2024

    Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

  3. 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.

  4. Breaking Barriers In Malaria Prevention With A Mobile Cleanroom 6/19/2024

    The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

  5. Deploying A Modern HPLC For Biopharma Analysis In QC Environments 4/16/2024

    Explore findings from a study evaluating the performance of a modern HPLC system in comparison to a legacy system in a routine QC testing environment for biopharmaceuticals.

  6. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  7. Data Integrity In The Quality Control Lab: No Pen, No Pain 12/10/2024

    Data integrity in pharmaceutical QC labs is critical for product safety. This webinar explores digital solutions to improve traceability, reduce paperwork, and enhance workflows.

  8. Data Intelligence Requires An Intelligent, Data-Driven Approach To Digital Transformation 5/9/2024

    An intelligent and data-driven digital transformation is the key to data intelligence. Discover how in 5 simple steps.

  9. Water Activity: A Better Approach For Lyo Moisture Determination 3/24/2025

    Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

  10. 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.