Featured Articles

  1. Safeguarding Biologic Integrity Through Enhanced Component Compatibility 2/4/2026

    For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

  2. Optimizing Syringe Performance For Reliable Drug Delivery 2/4/2026

    Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

  3. Maintaining Sterility Through Precise Component Design And Manufacture 2/4/2026

    Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

  4. 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.

  5. Most Frequently Asked Questions 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.

  6. Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 8 2/4/2026

    Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

  7. Designing Robust Studies To Meet Auto-Injector Performance Requirements 10/30/2025

    Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.

  8. Establishing And Safeguarding Shelf Life In Combination Products 10/27/2025

    Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

  9. A Pathway For Regulatory Success For Devices In Combination Products 10/27/2025

    Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

  10. FAQs On The Revised EU GMP Annex 1: Volume 6 9/21/2025

    The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.