Insights On Regulatory Compliance

1. From Open Cleanrooms To Closed Systems – What Is Driving The Change? 3/14/2025

   Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

2. The Role Of PUPSIT In A Contamination Control Strategy 7/25/2023

   Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

3. Correlating Stopper Height To Container Closure Integrity 11/21/2023

   Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

4. Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements 6/19/2024

   Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

5. Accelerated Development: Gene Therapy Vs. Small Molecule 12/26/2023

   Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

6. State Of Validation Report 2024 12/17/2024

   Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.

7. 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.

8. ICH Q12 Implementation: Regulatory Intelligence And PACM Agility 7/9/2024

   Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

9. Navigating GxP Compliance Challenges 10/30/2024

   Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

10. How Manufacturers Navigate Labor Shortages, AI, And Quality Challenges 5/30/2025

    Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.