Regulatory Articles

  1. The 5 Ws Of A Human Factors Strategy 3/31/2025

    A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

  2. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

  3. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

  4. Sustainable Solutions For Medical Devices 1/6/2025

    Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

  5. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

    Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

  6. Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs 8/27/2024

    Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

  7. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

  8. Performance Test According To Chapter <41> Of The USP 7/21/2023

    This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.

  9. Eccentric Loading Test (Eccentricity) With External Test Weights 7/21/2023

    In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.

  10. One-Point Calibration With External Test Weights 7/21/2023

    This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.