Office of Pharmaceutical Quality
2022 OPQ Annual Report (PDF - 2 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 of Biotechnology Products
- Office of Lifecycle Drug Products
- Office of New Drug Products
- Office of Policy for Pharmaceutical Quality
- Office of Pharmaceutical Manufacturing Assessment
- Office of Program and Regulatory Operations
- Office of Quality Surveillance
- Office of Testing and Research
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
- 2022 OPQ Annual Report (PDF - 2 MB)
- 2021 OPQ Annual Report (PDF - 4 MB)
- 2020 OPQ Annual Report (PDF)
- 2019 OPQ Annual Report (PDF)
- 2018 OPQ Annual Report (PDF)
- 2017 OPQ Annual Report (PDF)
Report on the State of Pharmaceutical Quality
- 2021 Report on the State of Pharmaceutical Quality (PDF - 1 MB)
- 2020 Report on the State of Pharmaceutical Quality (PDF - 1 MB)
- 2019 Report on the State of Pharmaceutical Quality (PDF - 793 KB)
- 2018 Report on the State of Pharmaceutical Quality (PDF - 285 KB)
- White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2 MB)
- FDA Pharmaceutical Quality Oversight (PDF - 2 MB)
- Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals (PDF - 551 KB)