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  1. Development & Approval Process | Drugs

Pharmaceutical Quality Resources

Recent updates

09/20/21 - Food and Drug Administration announced the availability of a guidance for industry titled, “Questions and Answers on Quality-Related Controlled Correspondence.”

We recommend that industry review these Q&A before submitting a controlled correspondence for one of the scientific and regulatory topics captured in this guidance. Additional Q&A will be added periodically to this new page: Questions and Answers on Quality Related Controlled Correspondence. We intend to use this format to provide timely answers to questions about generic drug development related to quality.  ​


Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER established the Office of Pharmaceutical Quality (OPQ) to ensure a uniform drug quality program across all sites of manufacture, whether domestic or foreign,  and across all human drug product areas – new drugs and biologics, generics, and biosimilars—and also over-the-counter drugs and compounded drug products. This white paper provides additional background regarding OPQ and the FDA’s oversight of pharmaceutical quality.

Patients and consumers can learn more about quality and how Current Good Manufacturing Practices (CGMPs) impact them.

The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.

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