Insights On Quality Control

  1. 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.

  2. A Closer Look At Multi-Lane Checkweighing In Pharma 5/2/2025

    Learn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.

  3. Engineering Excellence: JHS And Groninger's Partnership Drives Pharma Innovation And Local Growth 7/7/2025

    JHS and groninger’s partnership powers expansion with advanced aseptic filling lines, driving innovation, quality, and community growth through shared values and strategic collaboration.

  4. Detection And Quantification Of Amorphous Content In Materials 12/30/2024

    Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.

  5. Optimizing Contamination Control: Strategy Planning And Execution 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  6. Implementing A Risk-Based Approach To Calibration 2/20/2024

    Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

  7. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  8. 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.

  9. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  10. A Comprehensive Solution For Critical Sample Analysis 6/19/2024

    Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.