Development and Manufacture of Drug Substances (FDA Guidance Document)
cGMP – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (Code of Federal Regulations)
cGMP – Current Good Manufacturing Practice for Finished Pharmaceuticals (Code of Federal Regulations)
Modernizing the Way Drugs are Made: A Transition to Continuous manufacturing (FDA) - Continuous vs Batch Manufacturing
eDRLS: Electronic Drug Registration and Listing System (FDA) - Register drug establishment and list products
Drug Establishments Current Registration Site (FDA) - Look up registered establishments
Manufacturing broadly refers to the general production of a medical product. This process is different for pharmaceuticals/drugs, medical devices, and biologics/biosimilars; however, there are common manufacturing principles and practices followed by manufacturers for all medical product types. In Figures 1, 2, and 3 below, you can see batch, continuous, and biological manufacturing processes, respectively. For information on devices, go to the Manufacturing Devices section.
Manufacturers must comply with Current Good Manufacturing Practices (cGMP), which refers to the regulations enforced by the FDA to ensure the “proper design, monitoring, and control of manufacturing processes and facilities” of medical products. These regulations outline production standards and include the minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packaging of a medical product. The FDA enforces cGMP compliance by conducting surveillance inspections of manufacturing facilities to assess their compliance with cGMP and conducting application-based inspections as part of a marketing application filed with the FDA. Note that it is harder to test the final product's safety and potency for biologics. The starting materials come from living systems unlike traditional drug products that consist of pure chemical substances. Because of this, the FDA monitors the manufacturing of biologics from its early stages paying close attention to any changes to the process, equipment, or facility that can affect the product.
Additionally, the FDA requires registration of domestic and foreign companies (or establishments) that manufacture, repack, or re-label drug and biologic products, including vaccines, and devices marketed in the United States. These companies must also provide a list of all their commercially distributed products.
Click each title below to reveal the resources
Developing and Manufacturing Drugs Including Biologics (FDA)
cGMP – Biological Products: General (Code of Federal Regulations)
Biological Product Deviation Report
Manufacturing and Testing of Monoclonal Antibody Products (FDA)
Tissue Establishment Registration (FDA) - Register tissue establishment and list products
HCTERS: Human Cell Tissue Establishment Registration (FDA) - Look up registered establishments
BER: Blood Establishment Registration and Product Listing (FDA) - Register blood establishment and list products