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  5. Office of Quality Surveillance
  1. Center for Drug Evaluation and Research | CDER

Office of Quality Surveillance

Who We Are

The Office of Quality Surveillance (OQS), part of CDER’s super Office of Pharmaceutical Quality, continuously monitors and provides the state of quality for all regulated sites and products.

What We Do

  • Assures that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.
  • Coordinates Office of Quality Surveillance analytics, informatics, and research and development efforts to enable programmatic enhancements, efficiencies, and data integration toward a comprehensive quality surveillance program that can support other Center for Drug Evaluation and Research (CDER) and Office of Pharmaceutical Quality (OPQ) supply chain oversight needs.
  • Directs analytic and predictive programs to assess and report on the state of quality of regulated industry at manufacturing site and drug product levels using informative, innovative, and impactful data sources.
  • Develops innovative approaches to quality surveillance and supply chain oversight that complement established inspection programs and enhance surveillance coverage, international collaboration, and industry engagement.
  • Manages quality-related intelligence and risks about manufacturing sites and drug products to inform future quality surveillance resource planning, response actions and communications (e.g., mitigation of supply chain disruptions and drug shortages, enforcement decisions, and inspectional strategies).
  • Collaborates with Food and Drug Administration (FDA) business partners to recommend and develop regulations, guidance, and policy that improve regulatory reporting, mitigate risks, and address recurring or acute manufacturing quality issues and product quality defects.

Office Organization

These organizations report to the Office of Quality Surveillance:

  • Division of Quality Intelligence I
  • Division of Quality Intelligence II
  • Division of Quality Intelligence III

Resources



 
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