10 Things to Know about CDER’s Pharmaceutical Quality Functions

Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. When CDER receives a prescription drug application for approval, we evaluate whether the drug can be made to consistently meet quality standards. Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the processes used to manufacture the drug. Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients. CDER also monitors drugs on the market and the facilities making them to ensure continued quality.

Here are some things to know about CDER’s pharmaceutical quality functions:

1. Before FDA approval, prescription drug manufacturers must prove their drugs are safe, effective, and meet quality standards. FDA’s quality standards are the same for all drug manufacturers, no matter where they are located (foreign or domestic) or whether they manufacture generic or brand-name drugs.
2. CDER works to develop national and international policies that establish quality standards for drug manufacturers. For example, we publish guidance documents to help drug manufacturers understand regulatory requirements and best practices so they can produce high-quality drugs, and we work with industry organizations and international regulators to advance pharmaceutical quality policies. CDER’s research informs policy development by providing the latest scientific information related to pharmaceutical quality.
3. During our review of a drug application, CDER examines how the manufacturer will ensure the identity, strength, consistency, and purity of the drug. We do this in part by evaluating the manufacturer’s facility and manufacturing process to determine whether the drug can be manufactured in compliance with U.S. law and regulations. 
4. FDA performs a risk-based assessment of facilities listed in a drug application, which includes the facilities used to manufacture a drug, laboratories, and packaging facilities. FDA uses inspections as one tool to help ensure facility and process quality. During the drug approval process, CDER uses a risk-based approach to determine which drug manufacturing facilities need to be inspected prior to approving the drug (for example, an inspection is typically conducted if the drug will be the first product made at a newly built facility). A drug will not be approved if investigators discover a significant quality issue during an inspection prior to approval. Critical manufacturing problems need to be corrected before CDER can approve a drug.
5. CDER maintains an inventory of all facilities engaged in commercial manufacture of US marketed drugs (which we call CDER’s Site Catalog). Most facility inspections are surveillance inspections, which assess whether the facility is operating with processes in place to assure quality and is in compliance with statutory and regulatory requirements. CDER uses a risk-based model to prioritize surveillance inspections among facilities subject to inspection. Risk factors include the compliance history of the facility, recalls or quality complaints linked to the facility, and the type of drugs manufactured at the facility such as sterile injectable drugs.
6. FDA also inspects manufacturers who make non-application drugs (drugs marketed without an FDA-approved application), such as many over-the-counter drugs, to ensure the quality and safety of drugs marketed or sold in the U.S.
7. CDER may request documents from a facility or request to remotely interact with a facility to evaluate compliance with required manufacturing practices. CDER also uses inspection information from regulatory partners in other countries. These alternative tools to inspection allow CDER to obtain information about manufacturing facilities without physically visiting the facility.
8. We take action when there is a safety or quality concern. We may recommend a company recall its drug from the market or add a company to an “import alert” to help stop potentially unsafe products from entering the U.S. CDER may issue a “warning letter” advising a company of their manufacturing violations.
9. CDER maintains an inventory of all drugs marketed in the U.S. (which we call CDER’s Product Catalog) and we sample and test drugs from this list, based on risk, to monitor for quality issues. With approximately 150,000 drugs in CDER’s Product Catalog, we select products for sampling and testing based on data received from FDA investigators, manufacturers, distributors, and wholesalers, as well as directly from consumers and patients. Decades of sampling and testing have shown that the vast majority of legally marketed drugs meet quality standards.
10. Report any problems or concerns you have about the quality of a drug to FDA’s MedWatch program.