Featured Pharma Online Editorial

1. Struggling With GxP Systems? There's A DAP For That 4/2/2025

   A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

2. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

3. Embracing Turnkey And Outsourced Quality Management In Biopharma 3/28/2025

   In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

4. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

   While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

5. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

   The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

6. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

   Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

7. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

   Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

8. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

   Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

9. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

   The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

10. Deploy AI To Become A cGMP 'Special Agent' With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."