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What Is GMP & Why Is It So Important?

GMPs (Good Manufacturing Practices) are government-mandated systems to ensure that food, drugs and medical devices are safe and effective.

  1. Importance

    • GMPs safeguard consumers by keeping harmful substances out of food and drugs. These government regulations help prevent product recalls and lawsuits. The U.S. Congress created the first GMPs in 1963 after the sleeping aid thalidomide caused more than 10,000 infant deformities in Europe and was almost allowed to be sold in the United States.

    Enforcement

    • Sanitation, record keeping, testing raw materials, worker qualifications and equipment safety are all regulated by GMPs. In the United States, the Food and Drug Administration (FDA) enforces GMPs and inspects production facilities. FDA regulations refer to cGMPs (current Good Manufacturing Practices). In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA) enforces GMPs. In Australia, the enforcement agency is the Therapeutical Goods Administration (TGA). The World Health Organization's version of GMPs are used in more than 100 countries, primarily in the developing world.

    Exports

    • GMPs also increase the export potential for drugs. Most countries will not accept medicines that have not been made to GMP standards, according to the World Health Organization.

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