What is cGMP?
Good Manufacturing Practices (GMPs) are regulations that apply to the methods, equipment, facilities, and controls required for manufacturing various products, including foods, pharmaceutical products, veterinary products, and medical devices. Most GMPs vary by country.
In the United States, GMPs relating to pharmaceutical formulation are referred to as Current Good Manufacturing Practices (cGMP). The U.S. cGMP regulations are enforced by the United States Food and Drug Administration (FDA) according to Title 21 of the Code of Federal Regulations. The regulations set forth in Part 210 as well as Parts 211 through 226 of Chapter I, Title 21, “contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.” [21 CFR 210.1(a)].
All drug-related products, whether prescription or over-the-counter, that are intended for commercial use in the United States must be produced according to the FDA’s cGMP regulations. “The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated . . . and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.” [21 CFR 210.1(b)]. The regulatory action can range from the recall or seizure of the non-compliant products to fines and even jail time.
New drug development that is carried out according to cGMP regulations is critical for ensuring the drug product is safe, properly identified, of the appropriate strength or potency, pure, and of high quality. Manufacturers, processors, and packagers of pharmaceuticals are required to take proactive steps to ensure adherence to cGMP regulations. They must take a top-quality approach in performing their responsibilities in order to avoid contamination and errors.
What Falls Under cGMP Regulations?
cGMP regulations identify a variety of responsibilities for manufacturers, processors, and packagers of pharmaceuticals to follow. For example, cGMPs necessitate specific documentation and other recordkeeping, quality control unit responsibilities, personnel qualifications and responsibilities, design and construction standards, sanitation and cleanliness standards, equipment verification, process validation, and standards for complaint handling, equipment, and product testing.
The documentation requirements are an extremely important aspect of cGMP. Manufacturers, processors, and packagers must detail every aspect of the process, activities, and operations they utilize during their individual pharmaceutical related tasks. If the documentation showing how a product was made and tested is not correct, the product will not meet the required cGMP manufacturing specification. Consequently, the product will be considered contaminated or adulterated and cannot be distributed within the United States.
cGMP rules also regulate the training necessary to perform duties relating to the manufacture, processing, and packaging of pharmaceuticals. The cGMP requirements for dosage form development in the United States mandate explicit education, training, and experience for individuals who perform certain functions.