Insights On Regulatory Compliance

  1. The Ultimate Guide To Biological Indicators 5/27/2025

    Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device manufacturing, as well as how choosing the right one ensures safety, compliance, and product integrity.

  2. Visual Inspection Of Advanced Therapy Medicinal Products 9/2/2025

    Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.

  3. The Importance Of Vendor And Supplier Quality Management 9/20/2024

    Explore the importance of supplier quality management, relevant standards, regulatory audits, best practices, and the overall significance of this practice within the life sciences sector.

  4. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

  5. Automated PUPSIT For Drug Product Applications 1/13/2026

    Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.

  6. Optimizing Cleaning And Disinfection As Part Of An Effective CCS 6/6/2024

    Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

  7. 5 Key Principles Of Cleanroom Particle Counting 6/24/2025

    Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

  8. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

  9. Maximize Operational Readiness And Efficiency Without Compromising Quality 12/12/2025

    Discover how digital transformation drives efficiency, agility, and compliance in pharmaceutical manufacturing to optimize processes, improve quality, and accelerate time-to-market.

  10. 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.