21 CFR 820 is also known as medical devices GMP (Good manufacturing practices).  These are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high quality, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end-user. Additional tenets include ensuring the product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.

GMPs are overseen by regulatory agencies in various countries.  In the United States, GMP is enforced by the US FDA, but FDA does not issue a GMP certificate nor does the FDA recognize one issued by a third-party certification body.  They do site audits and inspections based on 21 CFR 820.

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  • Quality Manual
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