Insights On Regulatory Compliance

  1. X-Ray Inspection For Supplement Safety 2/6/2025

    Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

  2. 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.

  3. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

  4. Innovative Strategies For Residual DNA And Viral Titre Quantitation 5/22/2025

    Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.

  5. 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.

  6. ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments 2/22/2024

    Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

  7. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  8. Remote Regulatory Assessments Q&A 2/20/2024

    Explore what Remote Regulatory Assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.

  9. Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It 3/25/2025

    Learn how thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.

  10. How To Easily And Quickly Monitor Cleanrooms 5/6/2024

    Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.