Knowledge Management: A Cornerstone of GMP Quality Systems

Knowledge Management (KM) is increasingly recognized as a key enabler of effective Pharmaceutical Quality Systems (PQS), alongside Quality Risk Management, as emphasized in ICH Q10. In GMP-regulated environments, KM ensures that critical product and process knowledge is systematically captured, shared, and applied throughout the product lifecycle—from development to commercial manufacturing and discontinuation.

Strong KM practices support regulatory compliance, continuous improvement, and operational efficiency. They transform isolated “tribal knowledge” into organizational assets, ensuring that lessons from deviations, audits, inspections, and tech transfers benefit the entire company. By creating accessible repositories, companies can prevent recurring issues, improve inspection readiness, accelerate onboarding, and reduce the risks of knowledge loss.

Beyond compliance, KM fosters a culture of learning where cross-functional and cross-site collaboration drives smarter, science-based decision-making. For QA professionals, KM links all quality system elements into a cohesive whole—making it a foundation for resilience, efficiency, and sustainable growth in pharmaceutical manufacturing.

18-08-2025