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FDA法規

FDA 21 CFR Part 11

“Part 11,” as it is commonly called, is the section of Title 21 of the United States’ Code of Federal Regulations that describes the FDA’s regulations on electronic records and electronic signatures. It outlines the conditions under which electronic records and signatures can be judged to be dependable and comparable to paper records. As such, it requires life sciences and other FDA-regulated industries to implement controls on software systems that are involved in processing and managing quality data.

FDA 21 CFR Part 111

Specific to dietary supplements, Part 111 represents the FDA’s regulatory requirements for current good manufacturing practices (cGMPs). The final rule on Part 111 was established in 2007 in an effort to ensure that any foreign or domestic company that manufactures, packages, labels or holds dietary supplements implements proper controls. Such controls are in place for dietary supplements and ingredients with an expectation that they will be processed in a consistent manner (i.e., consistency in regards to identity, purity, strength and composition) and that they will meet the anticipated standard of quality.

FDA 21 CFR Parts 210-211

All pharmaceutical manufacturers need to be keenly aware of the particulars of FDA 21 CFR Parts 210-211. These regulations mandate that all drugs need to be made according to current good manufacturing practices, or cGMPs, which are intended to provide an assurance that companies have sufficient design, monitoring and control of manufacturing processes and facilities. Parts 210-211 are generally applicable to drug makers’ processes that involve the manufacturing, processing, packing, or holding of drugs intended for human consumption. According to the FDA, adherence to these regulatory guidelines helps assure the identity, strength, quality and purity of drug products.

FDA 21 CFR Part 820

Medical device manufacturers are intensely scrutinized by the FDA to ensure their products are safe and suitable for their intended use. The guidelines set forth in 21 CFR Part 820 are focused on the establishment of quality systems that safeguard manufacturers’ medical devices from inconsistency. The Part 820 quality systems regulation affords an “umbrella” approach to current good manufacturing practices (cGMPs) in that it provides a basic framework of guidelines within which manufacturers are allowed to fill in appropriate processes and procedures specific to their devices.

FDA 21 CFR Parts 1270-1271

Organizations that deal with human cells, tissues and cellular- and tissue-based products are subject to FDA 21 CFR Part 1270-1271. These products, also known as HCT/Ps, are frequently used in life-saving medical procedures. The FDA enforces Good Tissue Practices (GTP) through the administration of Part 1270-1271 with the intention of guaranteeing the safety of HCT/Ps and preventing the introduction, transmission and spread of communicable diseases.

FDA 21 CFR Part 606

For the purpose of designating that blood and blood components are safe, pure and effective, the FDA has outlined the current good manufacturing practices (CGMPs) for blood establishments in 21 CFR Part 606. It provides guidelines for blood establishments’ facilities, processing procedures, compatibility testing, distribution methods, controls and more. Part 606 includes the accountabilities of the personnel involved in the aforementioned activities as well.