Contributing Editors

1. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

   In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

2. Designing Facility Monitoring Systems For Cleanrooms 12/4/2023

   Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

3. How Can Digital Twins Get Us Closer To Pharma 4.0? 11/28/2023

   Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.

4. Your 6 Priority Areas For A Successful 2024 11/27/2023

   As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.

5. Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging 11/21/2023

   Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?

6. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

   Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

7. A Brief Introduction To Environmental Monitoring For Startups 11/17/2023

   Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

8. Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems 11/16/2023

   With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.

9. Your Local Affiliates Want More From Your Global Regulatory Information Management 11/9/2023

   Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.

10. Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges 11/7/2023

    Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.