Pharmaceutical Quality Resources
Recent Updates
The CMC Readiness Pilot is starting April 1, 2023. CDER and CBER will begin accepting requests to participate. See the FRN notice for details on how to apply.
FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors.
Drug manufacturers are required to ensure the safety and quality of their drugs. As FDA works to better understand the potential sources of benzene in drugs, FDA reminds manufacturers of drugs marketed under approved applications and manufacturers of other drugs, including over-the-counter monograph drug products, of their obligation to ensure their products conform to appropriate quality specifications.
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, biosimilars, over-the-counter drugs and certain compounded drugs.
The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.
Quality Information for Applicants: Chemistry, Manufacturing, and Controls (NDA, ANDA, BLA, and IND applications)
The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing or conducting a clinical trial. They provide information relevant to various application types. Much of the technical and scientific information will also be helpful for manufacturers of non-application drugs, such as OTC monograph products:
The following resources provide additional details for specific types of applications:
Advancing Product Quality
FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.
Contact for Further Information:
