Featured Pharma Online Editorial

1. 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.

2. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

   Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

3. AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence 6/23/2025

   Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

4. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

   CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

5. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

6. What Patients Say Matters: How AI Analyzes Sentiment to Improve Generic Drug Oversight 5/22/2025

   Employing multiple AI models to analyze public sentiment of generic drugs minimizes bias and enhances reliability. This makes AI a proactive tool for pharmaceutical quality assurance.

7. 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.

8. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

   Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

9. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

   Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

10. 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.