cGMPs BT 202 Biotechnology Techniques II

Food and Drug Administration Established under 1906 Pure Food and Drugs Act to prevent sale of unacceptable food and drugs Became the FDA in 1930 to enforce food and drug legislation Currently holds jurisdiction over most food products, human and animal drugs, medical devices, biologicals, radiation-emitting products, cosmetics, and animal feed

History In 1938 the revised Food, Drug, and Cosmetic Act was passed requiring pre-release drug safety testing In 1962 an amendment was passed requiring proof of safety and effectiveness for drugs In 1963 the first set of Good Manufacturing Practices (GMP) was published GMPs were revised in late 1970s to include requirements for SOPs, validation, and extensive documentation

cGMPs Current Good Manufacturing Practices Regulations enforced by FDA that provide for systems assuring proper design, monitoring, and control of manufacturing processes and facilities GMPs apply to all products regulated by the FDA Published in CFR and available to the public

cGMPs 21 CFR contains regulations relating to food and drugs Parts 210 and 211 contain cGMP regulations relating to pharmaceutical products Additional parts of CFR 21 list cGMPs for other products regulated by the FDA Entities involved in manufacture and sale of FDA regulated products must adhere to cGMPs

21 CFR (a) Applicability of current good manufacturing practice regulations. (a) The regulations in this part and in parts 211 through 226 of this chapter as they may pertain to a drug and in parts 600 through 680 of this chapter as they may pertain to a biological product for human use, shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event that it is impossible to comply with all applicable regulations in these parts, the regulations specifically applicable to the drug in question shall supersede the more general.

GMPs Regulations often arise from a tragedy or public outcry and are meant to protect consumers FDA-regulated entities must prove they are operating under cGMPs applicable to their facilities Facilities found in violation of regulations face penalties for their actions and may be placing consumers at risk of harm

FDA and GMP The FDA is responsible for oversight of facilities falling under its jurisdiction FDA has the responsibility of inspecting facilities and reporting findings Anyone working in a biotechnology facility that is FDA regulated has a responsibility to understand and follow cGMPs for that facility

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