Insights On Regulatory Compliance

  1. Revolutionizing Aseptic Fill/Finish With Innovation 4/21/2025

    Experience an innovative aseptic fill-finish technology designed for ATMP production in this live demo, which is a cutting-edge solution that ensures optimal efficiency and product quality.

  2. ISO/TR 14644 -21:2023 Cleanrooms And Associated Controlled Environments — Part 21: Airborne Particle Sampling Techniques. 3/5/2026

    Avoid common sampling errors and ensure cleanroom compliance. Master correct probe placement and tubing configurations to align with the latest industry standards and improve data accuracy.

  3. Accelerating Batch Release With Agentic AI 1/29/2026

    Agentic AI is redefining manufacturing by accelerating batch release and sharpening real‑time insights. With the right data and governance, teams can gain faster analytics and improved efficiency.

  4. Microbial Challenge In-Use Studies 6/13/2024

    Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

  5. Ringing The Alarm: Unified Data For GMP Annex 1 Compliance 11/12/2025

    Alarm monitoring can be more than compliance. Learn how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.

  6. Why Compounding Pharma Manufacturers Should Evaluate BFS Systems 12/5/2024

    Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.

  7. Leveraging A Modern HPLC System For Peptide Drug Substances Analysis 8/22/2024

    This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

  8. 2025 And Beyond: Another Look At Upcoming NDSRI Regulations 8/21/2025

    The presence of nitrosamine drug substance-related impurities (NDSRIs) in medications has become an urgent issue for the pharmaceutical industry. Understand the acceptable intake (AI) limits.

  9. Enabling NGS-Based Product Characterization And Biosafety Assays 1/29/2026

    Evolving regulations are shaping the adoption of NGS for biosafety and product characterization. Learn what teams must consider when validating modern sequencing assays within GMP‑regulated environments.

  10. Build A Culture Of Clean To Elevate Your Cleanroom 2/12/2026

    Keeping your cleanroom spotless is vital for product quality and patient safety. Consider these important factors for how to build a culture of clean and how your cleanroom will benefit.