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A Review on Current Good and Manufacturing Practices

Karan Gupta

Abstract


The CGMP and effluent  emission  regulation of the US Food and Drugs Administration  (FDA) and manufacturing effluent discharge and emission  regulation of the US Environmental protection Agency  (USEPA) require  contain manufacturer, use and disposal of pharmaceuticals with the goal of minimizing the releasing the  pharmaceuticals chemical into the environment. It is important to understand the relevance of current CGMP regulation and emission regulation that have a direct bearing on the releases of pharmaceuticals chemicals in the environment during manufacture, use and disposal of active pharmaceuticals ingredients and drugs product. This knowledge may help us assess the quantity of residues that may be released into the environment. Additionally, the information on physical, chemicals and degradation and sorption properties of the pharmaceuticals chemicals may help determine the net residue level that could persist in the environment to evaluate if such residues have any bearing on human and environment health. CGMP along with Good Agriculture practice, Good Laboratory Practice and Good Clinical Practice, are overseen by regulatory agencies in the United State, Canada, Europe, China and other countries. A consumer usually cannot detect (through smell, touch or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of the batches. CGMP reminding manufacturer that  they must employ technologies and system that are  up-to-date in order to comply with the regulation. It is promulgated by the USFDA under the authority of the Federal Food, Drug and Cosmetic Act. The regulation  make sure that a product is safe for use, and that it has the ingredients and strength it claims to have to protect the consumer from purchasing a product that is not effective or even dangerous for  health.

Keywords: cGMP, FDA, USEPA, USFDA, FFDCA, CAPA, Quality Management.


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References


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