Insights On Regulatory Compliance

  1. State Of Validation Report 2024 12/17/2024

    Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.

  2. Exploring Payer Coverage Of Anti-Obesity Medications 4/14/2025

    Understanding payer strategies for anti-obesity drugs is crucial. A recent study investigated commercial formulary trends, confirming cost as a major barrier despite positive patient outcomes.

  3. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

  4. Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements 6/19/2024

    Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

  5. 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.

  6. How Manufacturers Navigate Labor Shortages, AI, And Quality Challenges 5/30/2025

    Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.

  7. Your Global Partner In Pharmaceutical Contamination Control 6/24/2025

    Ensure cleanroom compliance with an expert team that helps you interpret critical data, align with global regulations, and maintain control through proactive contamination strategies.

  8. Don't Skip Preformulation: Your Blueprint For Drug Development Success 9/22/2023

    Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.

  9. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  10. A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks 6/6/2024

    A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.