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More About GMP

Good Manufacturing Practice (GMP) Regulations are issued by FDA under the Federal Food, Drug, and Cosmetic Act.  The set out quality standards for the manufacture of products regulated by FDA, including pharmaceuticals, medical devices, biologic products including blood, food, and other specific products.

GMP Regulations carry the force of law, and violating them can result in serious consequences including seizures, injunctions, and prosecution of those responsible.

GMP Mastery™ embraces the philosophy that GMP Regulations provide a roadmap to mastering performance.  Following the GMP regulations is NOT just a matter of compliance, but also of aligning an organization's values, objectives and measures; assuring quality, productivity, health/safety, and regulatory compliance; and adding value to all stakeholders.

Where did GMP come from?


Beyond GMP Compliance: How GMP Helps Organizations Align, Assure, and Add Value


Read the GMP regulations.


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