FDA Office of Pharmaceutical Quality
Information
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
The Office of Pharmaceutical Quality (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.
Our Mission: To assure that quality medicines are available for the American public.
Our Vision: To be a global benchmark for regulation of pharmaceutical quality.
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.