This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.
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FDA evaluates prescription drugs, including biologics, and some over-the-counter drugs, before they can be distributed in the United States to help ensure those products are safe and effective. Manufacturers and product sponsors that produce drugs, including active pharmaceutical ingredients (API), and biologics are subject to certain laws and regulations that ensure these products are manufactured in compliance with appropriate quality standards.
FDA reviews human drugs, including biologics, for safety, effectiveness and quality. Manufacturers and product sponsors are subject to FDA laws and regulations. See the links below for specific information on each type of product application:
- New drug application (NDA)
- Abbreviated new drug application (ANDA)
- Biologics license application (BLA)
Current good manufacturing practice (CGMP) regulations outline the minimum quality standards for manufacturing of drugs, including biologics, and are established to ensure that products are safe and effective for human use. See CGMP regulations for drugs and chemistry, manufacturing and controls (CMC) and CGMP guidances for biologics. Relevant regulations governing quality can be found in 21 Code of Federal Regulations (CFR) parts 210, 211, and 212 (drugs, including biologics), and the applicable requirements in parts 600-680 (biologics only).
Many drugs are required to have FDA approval prior to marketing. If FDA agrees to file an application for marketing, the agency performs a multi-disciplinary assessment of the facilities identified in the application and their manufacturing processes and related controls, including testing, to assess whether the drug substance and drug product are of sufficient quality and conform to the quality and purity characteristics that the drug purports or is represented to possess.
FDA has also published many guidance documents for applicants and manufacturers describing the types of quality-related studies, data, and other information that FDA recommends be submitted to meet the requirements described above. For human drugs, including biologics, FDA has issued guidance for many different manufacturing operations and drug types that encompass drug development through commercialization. Guidance covering FDA’s quality expectations can be found under these topic filters on the guidance page:
- Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
- Pharmaceutical Quality/Manufacturing Standards (CGMP)
- Pharmaceutical Quality/Microbiology
FDA also issues guidance documents with the International Council for Harmonisation (ICH). Visit FDA Guidance documents and filter by topic “ICH – Quality”. These quality guidances cover manufacturing quality for the drug substance (API) and finished drugs.
FDA inspects manufacturing facilities for drugs, including biologics, using a risk-based approach. A pre-approval inspection is often conducted as part of the review of an application to market a drug, including a biologic, and is an evaluation of a manufacturer’s readiness for commercial manufacturing under CGMP. A surveillance inspection is performed to monitor the manufacturing process and drug quality and evaluate whether a manufacturer is complying with CGMP. See the Compliance Program Guidance Manual (CPGM) for more information about how FDA performs these inspections, as well as other inspection program types. After the evaluation of a surveillance inspection is complete, the outcomes can be found in the inspection classification database.
Manufacturing facilities are required to electronically register their establishment and list the drugs, including biologics, they produce with the agency. See Drug Registration and Listing System for more information.
Imported products must meet the same FDA standards for quality, safety, and effectiveness as drugs, including biologics, manufactured in the United States. See Human Drug Imports and CBER-Regulated Products (biologic imports) for more information.
Applicants are required to submit postmarket safety reports of adverse events to FDA. Other entities (e.g., manufacturers, packers and distributors named on the product label) are required under certain circumstances to submit postmarket safety reports of adverse events to the agency or to the applicant. See FDA Adverse Event Reporting System and Vaccine Adverse Event Reporting System for more information on how to submit adverse events.
Applicants and manufacturers are also required to notify FDA about a permanent discontinuance or interruption in manufacturing of certain drugs and biological products under section 506C of the Federal Food, Drug, and Cosmetic Act. These timely notifications help our efforts to prevent or mitigate shortages of drugs, including biologics.
Additionally, applicants holding an approved NDA, ANDA or BLA are required to submit reports to FDA in certain circumstances under 21 CFR parts 314 and 600. See Field Alert Reports for reporting quality defects about drugs and Biological Product Deviations for reporting about biologics.