Insights On Regulatory Compliance

1. Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology 11/17/2023

   Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

2. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

   Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

3. Developing Effective Procedures 10/21/2024

   Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

4. 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.

5. An Introduction To Laminar Airflow Technology In Aseptic Processing 8/21/2023

   Explore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.

6. Biotech Files NDA Following Risk-Based Mock Inspection 6/14/2023

   See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.

7. Advancing Cell Therapy Manufacturing: Rapid Sterility Testing 5/7/2024

   The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

8. Three Vital Steps To QMS Implementation 11/7/2024

   When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS.

9. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

   Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

10. 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.