Insights On Regulatory Compliance

1. 5 Signs You've Outgrown Your Quality Management System (QMS) 12/27/2024

   An outdated QMS limits growth. Explore how upgrading to an advanced, configurable system like MasterControl can ensure scalability, automation and innovation. 

2. N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit 6/30/2025

   Discover a company that tripled productivity and cut costs by optimizing its seed train process to achieve major gains without infrastructure expansion.

3. AI Implementation To Enhance Quality 2/11/2025

   Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

4. Implementing A Risk-Based Approach To Calibration 2/20/2024

   Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

5. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

   Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

6. Navigating Regulatory Compliance: A Success Story In The Pharma Industry 4/10/2025

   Reveal how one pharmaceutical facility overcame strict cross-contamination rules and space limits without costly building modifications to ensure operational continuity.

7. Essential Insights Into Pharmaceutical Product Release: Part 2 1/13/2025

   Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.

8. Key Takeaways From The ISPE Ireland Annex 1 Event 4/12/2024

   Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.

9. Tips For Viral Vector Production 4/16/2024

   Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

10. Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence? 9/5/2023

    Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.