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  6. Offices of Product Quality Assessment I, II, & III
  1. CDER Offices and Divisions

Offices of Product Quality Assessment I, II, & III


Who We Are

The Offices of Product Quality Assessment (OPQA) I, II, & III, part of CDER’s super Office of Pharmaceutical Quality, protect and advance the public health through assessment and regulation of pharmaceutical quality in drug substance and drug products. They assure drug product quality during the lifecycle of brand name and generic drug products, and biological products including biosimilar products.

What We Do

  • Oversees, coordinates, and prioritizes the work of the different Product Quality Assessment divisions. Communicates and shares relevant information between Product Quality Assessment divisions and within The Office of Pharmaceutical Quality (OPQ).
  • Plans, develops, and directs the office strategy, within OPQ’s mission, to continuously improve or enhance the effectiveness and efficiency of quality assessment activities.
  • Executes and communicates high-level decisions, manages resources, monitors performance, and directs operations of the Product Quality Assessment divisions.
  • Directs and coordinates strategic communication of recommendations on the approvability of drug products, adequacy of drug substances, and product quality risks identified throughout their lifecycle (including post-approval change management) to appropriate stakeholders within other offices in OPQ, The Center for Drug Evaluation and Research (CDER), The Food and Drug Administration (FDA), and industry.
  • Serves as a liaison and resource to offices within OPQ, other offices within the FDA, and outside organizations on aspects related to drug quality including product design, drug product and drug substance characterization and testing, biopharmaceutics, as well as provides subject matter expertise in the development of policies, procedures, surveillance, and research that supports the evaluation of drug product or drug substance quality for CDER regulated products.
  • Coordinates with other OPQ, CDER and/or FDA offices, as needed, in scientific investigations and inspections to evaluate and assess any drug product or drug substance quality problems.

Office Organization

OPQA I

  • Division of Product Quality Assessment I
  • Division of Product Quality Assessment II
  • Division of Product Quality Assessment III
  • Division of Product Quality Assessment IV
  • Division of Product Quality Assessment V
  • Division of Product Quality Assessment VI

OPQA II

  • Division of Product Quality Assessment VII
  • Division of Product Quality Assessment VIII
  • Division of Product Quality Assessment IX
  • Division of Product Quality Assessment X
  • Division of Product Quality Assessment XI
  • Division of Product Quality Assessment XII

OPQA III

  • Division of Product Quality Assessment XIII
  • Division of Product Quality Assessment XIV
  • Division of Product Quality Assessment XV
  • Division of Product Quality Assessment XVI
  • Division of Product Quality Assessment XVII
  • Division of Product Quality Assessment XVIII
  • Division of Product Quality Assessment XIX

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