GMP & Quality Insights Blog | News, Careers & Compliance

Split-screen photo of a pharmaceutical operator making a sequence error on the production line and shadowy figures with thought bubbles showing behavioral challenges like peer pressure and unclear SOPs.

Behavioral CAPA: The Missing Link Between Human Error and Repeated Failure Patterns

Comparison of PDCA vs PDSA cycles showing why PDCA became more popular than Deming’s PDSA method

PDCA vs PDSA: Why PDCA Became Famous Even Though Deming Prioritized PDSA

Pharmaceutical worker hesitating to follow SOP in GMP manufacturing environment

The Psychology of Not Following SOPs — and How to Fix It

Visual of QbD evolution with pillars representing systems, behavior, and culture in pharma

The QMS4 Lens on QbD: A Modern Redesign Rooted in Human Systems

Illustration showing the human side of Quality by Design in pharma – representing behavioral systems, GMP culture, and process design

QbD 2.0 in Pharma: Designing Quality into People, Not Just Products