CGMP Regulations

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA assessors and inspectors determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.

Code of Federal Regulations (CFR). FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

The regulations enable a common understanding of the regulatory process by describing the requirements to be followed by drug manufacturers, applicants, and FDA.

• 21 CFR Part 314 and Part 600. Application and licensing submission requirements for new and generic drug applicants.

• 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.

• 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.

The following pages provide more information with respect to regulations for particular product types and manufacturing considerations:

• Compressed Medical Gases

• Positron Emission Tomography (PET)

• Field Alert Reports (for NDAs) and Biological Product Deviation Reports (for BLAs)

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

Pharmaceutical Quality Resources

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER developed a Quality Initiative and 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.

Guidances and Manuals on Pharmaceutical Quality

This page provides quick access to guidances documents for industry on pharmaceutical quality topics, including drug application/license policies on quality. In addition to the guidance document resources below, CDER Manuals of Policies and Procedures (MAPPs) are approved instructions for internal practices and procedures followed by FDA and CDER staff to help standardize the drug review process and other activities.

https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality

Inspection/Enforcement Resources

• Inspections Classifications Database: This database provides final inspection classifications for inspections related to currently marketed FDA-regulated products, including inspections of facilities that manufacture, process, pack, or hold an FDA-regulated product. The classifications are based upon findings identified during an inspection and Agency review for compliance.

• FDA Data Dashboard: This dashboard builds on data from resources such as the inspection database, and also provides information regarding compliance actions, recalls, and imports.

Inspection and Enforcement Programs and Guidelines

• Compliance Programs. These programs and instructions are for FDA staff, primarily investigators and compliance officers, when conducting and evaluating routine types of inspections, like CGMP inspections. Compliance Programs also provide guidelines for agency staff evaluating significance of violations, and may provide instructions for sampling regulated articles.

• Inspection and Enforcement references. This web site from the Office of Regulatory Affairs provides links to Compliance Policy Guides, Regulatory Procedures Manual, the Investigations Operations Manual, and related information. Chapter 4 of the Compliance Policy Guide covers human drugs, and Chapter 1 includes information on multiple commodities regulated by FDA.

https://www.fda.gov/drugs/pharmaceutical-quality-resources/inspectionenforcement-resources

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