Featured Pharma Online Editorial

1. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

2. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

   The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

3. How AI Is Revolutionizing Quality Management Systems 8/13/2025

   The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

4. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

5. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

6. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

   A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

7. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

   The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

8. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

   Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

9. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

   Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

10. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.