Manufacturing - Therapeutics

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.

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