Featured Articles

  1. 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.

  2. Contamination Control Strategies For Regulatory Compliance 4/24/2025

    Discover how a robust Contamination Control Strategy (CCS) can mitigate contamination risks and gain insights from Ugo Omeronye's detailed responses in our comprehensive reference guide.

  3. 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.

  4. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  5. Bacteria To Consider For The Growth Promotion Test: Should Anaerobic Cultures Be Included? 2/20/2025

    The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.

  6. Optimizing Microbial Air Sampling To Reduce False Positives In Cleanrooms 10/18/2024

    Learn how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

  7. Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing 10/18/2024

    Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

  8. Compressed Gas Systems In Aseptic Manufacturing 10/18/2024

    Learn about compressed gas systems and why effectively identifying and managing the risks associated with these systems is critical for maintaining product quality and ensuring compliance with GMP.

  9. Key Factors For Optimized Microbial Air Sampling 10/16/2024

    Learn about active air sampling and the characteristics of various microbiological sampling methods that are designed to optimize collection efficiency.

  10. Vaporized Hydrogen Peroxide (VHP) Resistance Testing 10/16/2024

    Explore test results demonstrating the suitability of a robust microbial sampler for environments where frequent exposure to harsh cleaning and sterilization methods, like VHP in isolators, is routine.