Quality/GMPs

Latest News

July 1st 2003

Pieces of the Inspection Puzzle: The Magnitude and Scope of Behind-the-Scenes Activities During an Inspection

A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.

July 1st 2003

Inside Washington: Debate Escalates Over Follow-On Biologics

By Jill Wechsler

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Subjectivity in Quality Risk Management

The authors discuss subjectivity in the ICH Q9 (R1) guidance document.

Phase-appropriate Compliance for Cell and Gene Therapies

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.