Insights On Regulatory Compliance

  1. Why And Where To Monitor In Aseptic Processing Areas 4/24/2025

    Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.

  2. What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry? 8/1/2024

    The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

  3. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  4. Why Biotech Leaders Can't Afford Delays In Document Review 5/15/2025

    Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

  5. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  6. Measuring And Monitoring Environmental Surface Residues 4/1/2025

    Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.

  7. Prioritizing Data Security Through Digital Transformation 5/2/2025

    Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

  8. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  9. Normalized Data In Microbial Continuous Monitoring 7/24/2025

    Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

  10. Rethinking Sustainability In Bioprocessing 5/22/2025

    Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.