cGMP, or current Good Manufacturing Practices, are regulations enforced by the US Food and Drug Administration (FDA) to ensure that systems are in place that assure proper design, monitoring, and control of manufacturing processes and facilities.
A company that adheres to cGMP regulations assures identity, strength, quality, and purity of products by requiring that we adequately control manufacturing operations. The quality system implemented helps to prevent instances of contamination, mix-ups, deviations, failures, and errors and this, in turn, assures that products meet their quality standards.
The FDA has published cGMPs for products across a variety of industries, including dietary supplements, drugs and pharmaceutical products, food processing and medical devices.
In October 1996, the FDA published a final rule on medical device cGMP indicating that it would revise the current requirements for medical devices and incorporate the regulations for medical device quality systems that we know today as 21 CFR Part 820. This part of the Federal Code of Regulations deals with the requirements for medical device quality systems that ensure the safety and effectiveness of medical devices sold in the United States.
Some of the main benefits of CGMP compliance include:
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