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. 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.

  3. Your Guide To Precise And Robust Separation Methods 11/12/2025

    Discover a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.

  4. From Day One Success To Everyday Improvement: The OR → OE Continuum 11/24/2025

    Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

  5. (Cross-) Contamination Control Through Effective Equipment Cleaning 5/6/2026

    Discover science-driven cleaning strategies that reduce cross-contamination, enable safe multiproduct manufacturing, and support faster, flexible GMP changeovers.

  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. Improved GLP-1 Receptor Agonist Peptide Recovery 6/30/2025

    Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

  8. 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.

  9. Building Control Strategies: It's Time To Go Digital 1/24/2025

    Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

  10. Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance 2/24/2026

    Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.