Article | August 31, 2022

What Does The "Current" In Current Good Manufacturing Processes (cGMP) Mean?

Source: AcuraBio

In the United States, the phrase "current good manufacturing practice" appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. FDA’s cGMP regulations for drugs establish minimum standards for cGMP compliance. But to comply with cGMPs, manufacturers at the minimum are required to establish systems to control every stage of the manufacturing process, including oversight and control of raw materials and components, design, processing, testing, packaging, and labelling, storage, and distribution. If implemented properly, these controls help assure that the product is of high quality and unadulterated and help to prevent the release of nonconforming products.

Manufacturers with aging facilities and technology are certainly in danger of being found by inspectors to not meet the requirement to remain “current” under cGMPs. These companies are more likely to experience problems with quality and correcting those problems may be expensive for these manufacturers.

AcuraBio offers an inclusive set of services including the production of cGMP material for pre-clinical studies and clinical trial material batches for Phase 1, 2 and 3 clinical studies. In this article, explore further: What does the "current" in current Good Manufacturing Practices (cGMPs) mean?


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