Insights On Regulatory Compliance

  1. A Regulatory Perspective: How Government Funding Spurs Scientific Innovation 3/25/2024

    Review the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy.

  2. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  3. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  4. Observations That Can Be Avoided With The Right Software Partner 3/31/2025

    FDA 483 findings frequently cite a lack of data integrity, process adherence, and quality control. Find out why these issues persist and the significant risks they pose to pharmaceutical manufacturers today.

  5. 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention? 2/19/2026

    Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

  6. Move Beyond Manual CQV Challenges With Digital Solutions 1/24/2025

    Review how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.

  7. Annex 21 – Are We On Track And Is There An Impact? 5/6/2024

    What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply?

  8. Environmental Monitoring Vs. Good Aseptic Technique 4/23/2024

    Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

  9. FAQs 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.

  10. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.