Category: GMP Asset Management

FDA’s April 2, 2026 Warning Letter to Purolea Cosmetics Lab appears to be one of the first publicly visible FDA drug CGMP enforcement actions to cite inappropriate AI use in pharmaceutical manufacturing. The lesson: AI changes the mode of error, not the locus of responsibility.

FDA and EMA’s January 2026 joint AI principles establish guardrails for AI use across manufacturing and the medicines lifecycle. For GxP operations teams, this means documented context of use, risk-tiered validation, ALCOA+ data governance, and lifecycle monitoring planned before drift occurs.

FDA inspection readiness starts long before an auditor arrives. Explore 9 pillars GMP manufacturers can use to strengthen documentation, asset control, training, and inspection response.

Disconnected EAM and QMS systems create real gaps in GMP operations—slowing investigations, increasing manual work, and introducing compliance risk. Here’s why integrating maintenance and quality systems is becoming essential—and how it creates a single, connected foundation for modern life sciences manufacturing.