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  1. CDER Offices and Divisions

Office of Pharmaceutical Quality


Cover photo of the CDER Office of Pharmaceutical Quality Annual Report


2023 OPQ Annual Report (PDF - 1.5 MB)

Who We Are

The Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public. OPQ integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. OPQ supports “One Quality Voice,” creating a uniform drug quality program across all sites of manufacture -- domestic or foreign -- and across all human drug product areas including new drugs and biologics, generics, biosimilars, and also over-the-counter drugs and compounded drug products. OPQ also encourages the adoption of emerging technologies to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector.

What We Do

 

  • Establish consistent, patient-focused quality standards.
  • Integrate the assessment of drug applications with the evaluation of manufacturing facilities, leading to a single, more informed quality assessment.
  • Identify quality problems that require corrective actions and work closely with other FDA offices if enforcement decisions need to be made.
  • Balance potential quality risks with the risk of a patient not getting a drug.
  • Anticipate quality problems before they develop to help prevent drug shortages.

Office Organization

Contact Us

E-mail: CDER-OPQ-Inquiries@fda.hhs.gov | Phone: 301-796-2400 | Fax: 301-796-9996

Office of Pharmaceutical Quality, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002

Reports

Annual

Report on the State of Pharmaceutical Quality

Related Information

White Papers




 
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