Office of Pharmaceutical Quality
OPQ 2018 Annual Report (PDF-5.6MB)
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 Pharmaceutical Quality Immediate Office
- Office of Biotechnology Products
- Office of Lifecycle Drug Products
- Office of New Drug Products
- Office of Policy for Pharmaceutical Quality
- Office of Process and Facilities
- Office of Program and Regulatory Operations
- Office of Surveillance
- Office of Testing and Research
- Emerging Technology Program
- Botanical Review Team
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
- Report on the State of Pharmaceutical Quality, 2018 (PDF - 285KB)
- OPQ Annual Report, 2017 (PDF - 10.43MB)
- Pharmaceutical Quality Resources
- White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2.4MB)
- Frequently Asked Questions about CDER’s Quality Initiative and Office of Pharmaceutical Quality
- CDER’s Quality Initiative