FDA Good Manufacturing Practices

Calibration. Cahbration of lab instmments is important to the accuracy of test results. CaUbration, the use of an accepted standard to adjust an instmment or measurement standard so as to improve the accuracy of the instmment or measurement, is an essential requirement of both the U.S. Food and Dmg Administration (FDA) Good Manufacturing Practice (GMP) (24) and the ISO 9000 standards (25). 

Food and Drug Administration (FDA) Good Manufacturing Practices make significant distinctions between acid, low acid, and acidified foods based on a finished equilibrium pH of 4.6. 

Hooten, Fred W., A Brief History of FDA Good Manufacturing Practices, Medical Device and Diagnostics Industry, May 1996. 

Two similar dosage forms, eg, tablets, that contain the same amount of the same dmg entity and meet USP/NF and current good manufacturing practices (FDA) are referred to as pharmaceutical equivalents (PE). When, upon adiriinistration, such tablets achieve similar profiles of AUC, and... 

Good Manufacturing Practice. The GMPs were issued by the U.S. FDA in 1978 to provide minimum quahty standards in the production of pharmaceuticals (qv) for the finished dosage form as well as their ingredients. The standard has been updated periodically. 

Current Good Manufacturing Practice for Finished Pharmaceuticals," Code of Federal Regulations, Tide 21, Part 211.25, U.S. FDA, Washington, D.C., 1988. 

In 2002, the FDA announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century . The purposes of this... 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Current Good Manufacturing Practice for Finished Pharmaceuticals , 1995, 21 CFR 211.186, FDA. 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

Good manufacturing practices (GMPs) ensure that products meet specific quality standards, are not adulterated or misbranded, and contain the correct ingredients and doses stated on the label. GMPs specifically for dietary supplements are being proposed from the FDA. Cases of adulteration have been reported to the FDA, and examples include a plantain product adulterated with digitalis and hibiscus tea adulterated with warfarin [29]. 

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