Insights On Regulatory Compliance

1. What Your Environmental Monitoring Isn't Telling You 6/25/2025

   Explore overlooked contamination sources, like residues, poor housekeeping, and training gaps, which offer practical strategies to strengthen your contamination control program.

2. Optimal Microbial Sampling Criteria 6/24/2025

   Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

3. A New Approach To Isolator Decontamination 4/8/2024

   How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.

4. Cell Therapy Process Development Made Easy 3/27/2024

   Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.

5. Single-Use Strategies For Uninterrupted Microbial Monitoring 2/22/2024

   Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.

6. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

   Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

7. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

   Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

8. PUPSIT As Part Of A Contamination Control Strategy (CCS) 8/21/2024

   Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

9. What Is OPC Counting Efficiency? 6/24/2025

   Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

10. Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration 6/26/2025

    A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.