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  1. Center for Drug Evaluation and Research | CDER

Office of Pharmaceutical Manufacturing Assessment

Who We Are

The Office of Pharmaceutical Manufacturing Assessment (OPMA), part of CDER’s super Office of Pharmaceutical Quality, assures that quality pharmaceuticals are consistently manufactured over the product lifecycle.

What We Do

  • Oversees, coordinates, and prioritizes the work of the different Pharmaceutical Manufacturing Assessment divisions. Communicates and shares relevant information between Pharmaceutical Manufacturing Assessment divisions and within The Office of Pharmaceutical Quality (OPQ).
  • Plans, develops, and directs the office strategy within OPQ’s mission to continuously improve and enhance the effectiveness and efficiency of manufacturing assessment, including process, facilities, microbial controls, and sterility assurance assessment.
  • Executes and communicates high-level decisions, manages resources, monitors performance, and directs operations of the Pharmaceutical Manufacturing Assessment divisions.
  • Directs and coordinates strategic communication of manufacturing-specific risk identified throughout the product lifecycle (including post-approval change management) to appropriate stakeholders in OPQ, The Center for Drug Evaluation and Research (CDER), The Food and Drug Administration (FDA), and industry.
  • Manages and coordinates the pre-approval inspections (PAIs), pre-license inspections (PLIs), and product specific post-approval programs. Serves as OPQ’s primary point of contact to  stakeholders within the FDA regarding regulatory and scientific matters related to PAIs and PLIs. Coordinates with other offices in OPQ, CDER, and FDA as needed in scientific investigations to evaluate and assess any drug product quality problems.
  • Serves as a liaison and resource to offices within OPQ, other offices in the FDA, and outside organizations on aspects related to manufacturing, facilities, and product quality. Provides subject matter expertise in the development of policies and procedures, surveillance, and research that supports the evaluation of manufacturing and facilities for CDER regulated products.

Office Organization

These organizations report to the Office of Pharmaceutical Manufacturing Assessment:

  • Division of Pharmaceutical Manufacturing Assessment I
  • Division of Pharmaceutical Manufacturing Assessment II
  • Division of Pharmaceutical Manufacturing Assessment III
  • Division of Pharmaceutical Manufacturing Assessment IV
  • Division of Pharmaceutical Manufacturing Assessment V
  • Division of Pharmaceutical Manufacturing Assessment VI

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