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ResourcesGMP and FDA Resources and LinksFDA Unique Device Identification (UDI) Program The FDA has established a new program called Unique Device Identification (UDI). The requirements establish a phased in system which creates unique medical device identifiers that are readable by both humans and machines. We can design labels to help you comply with this new requirement. You can access the FDA Guidance Document here- Unique Device Identification (UDI) GMP (Good Manufacturing Practice) Regulation Resource Links Good Manufacturing Practice regulations are promulgated by the United States Food and Drug Administration under the authority of the Food, Drug and Cosmetic Act The relevant FDA regulations which require that manufacturers, processors and packagers of drugs, medical devices and some food products take steps to ensure that their products are safe, pure and effective are contained in the Code of Federal Regulations
Over time, regulatory procedures, compliance guideline documents and FDA compliance policies provide further detail and clarity to the regulated community FDA Guidelines FDA Compliance Policy FDA Regulatory Procedures Manual FDA Compliance Program Manual FDA Inspection Guides FDA Warning Letters FDA CDER Guidance Documents FDA CDRH Guidance Documents GMP (Good Manufacturing Practice) Professional Associations Professional associations are often a helpful source of information sharing regarding cGMP label use, QSR label use, sound compliance practices and current agency interpretations among the regulated community and are an important part of ongoing professional education. We carry a full line of cGMP labels and QSR labels.
Training and Consultants A number of training and regulatory consultant businesses specialize in GMP regulations and practices. We have direct experience with the following: GMP Training Systems MWA, Inc. MWA offers a full range of consulting services in GCP, GLP, cGMP and GMP compliance. MWA provides consulting expertise from development through commercialization for the pharmaceutical, biotechnology, and medical device industries. (415) 388-1695 info@gxpsrus.com |