Is Your Facility GMP Compliant for 2020?
GMP, also known as cGMP, stands for current Good Manufacturing Practices, and is a set of regulations set forth by the U.S. Food and Drug Administration (FDA) to help ensure that various products intended for human consumption and use are safe and effective.
cGMP regulations mandate a quality-related methodology to manufacturing - enabling businesses to minimize product contamination, mislabelling and other errors. This protects the consumer from purchasing a product that may be effective or even dangerous.
GMP is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries now require that pharmaceutical and medical device companies must follow GMP regulations, and have created their own GMP guidelines.
Most of the GMP regulations address issues such as sanitation, process validation, equipment and document traceability, and personnel qualification. Failure of firms to comply with GMP regulations can result in product recall or seizure, fines and prison.
All Good Manufacuring Practice (GMP) regulations fall under the Code of Federal Regulations (CFR), TITLE 21: Food and Drugs, CHAPTER I: Food and Drug Administration, Department of Health and Human Services.
Pharmaceutical GMP: 21 CFR 210-212
Good Manufacturing Practices (cGMP) for the pharmaceutical industry deals with issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. The regulations are codified in 21 CFR Part 210, 211, and 212 that deal with drugs for human use. Regulations that deal with drugs for animal use are in 21 CFR Part 225, 226 - Animal GMP.
Medical Device GMP: 21 CFR 820
Good Manufacturing Practices (cGMP) for the medical device industry deals with having a solid Quality Management System (QMS) in place that is traceable and auditable. This regulation governs the methods, controls, and facilities used used in the design, manufacture, packaging, labeling, storage, installation, servicing, and maintenance of all finished medical devices for human use.
Food GMP: 21 CFR 106, 110, 117
Good Manufacturing Practices (cGMP) for the food industry complements the HACCP (Hazard Analysis Critical Control Points) program. 21 CFR Part 110 deals with food sanitation, food handling and food preparation issues. 21 CFR 106 deals with a specific food subset - infant formula. 21 CFR 117 deals with risk management issues around food.
Closely related is 21 CFR Part 111 - Supplement GMP that effects the dietary supplement industry. Although dietary supplements are regulated by the FDA as foods, they are treated differently from foods and from drugs.
Supplement GMP: 21 CFR 111
Good Manufacturing Practices (cGMP) for the dietary supplement industry deals with the manufacturing, processing and holding of these substances. Although dietary supplements are regulated by the FDA as foods, they are regulated differently from foods and from drugs.
Animal GMP: 21 CFR 225, 226, 507
Good Manufacturing Practices (cGMP) for the animal industry deals with issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. The regulations are codified in 21 CFR, Subchapter C - Drugs: General, Part 225, 226 that deal with drugs for animal use. 21 CFR Part 507 deals with food for animal consumption. Regulations that deal with drugs for human use are in 21 CFR Part 210-212 - Pharmaceutical GMP.
Blood GMP: 21 CFR 606
Good Manufacturing Practices (cGMP) for the biotech and blood industry deals with tissue and blood collection, handling, analysis and transfusion products.