In the United States, the Current Good Manufacturing Practice (cGMP) is the Food and Drug Administration (FDA) 's formal regulations on the design, monitoring, control and maintenance of manufacturing processes and facilities. Pharmaceutical and biotechnology companies comply with cGMPs to ensure that their products meet specific requirements, including characteristics, strength, quality and purity. Compliance is regulated by the FDA. There are many federal regulations related to cGMP, failure to comply with them will lead to criminal penalties.
The requirements of CGMP are flexible so that each manufacturer can decide how to use scientific and reasonable design, processing methods and testing procedures to best implement the necessary controls independently. The flexibility of these regulations allows companies to use modern technology and innovative methods to achieve higher quality production through continuous improvement. Therefore, the "C" in CGMP stands for "current" and requires the company to use the up-to-date technologies and systems to comply with regulations. If you’d like to know more about cGMP, just contact us or send us a query directly.
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