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FDA GMP Guidelines

The U.S. Food and Drug Administration establishes quality guidelines for food, drugs, medical devices and biologics. These quality guidelines are called good manufacturing practices. GMPs are law under the Federal Food, Drug, and Cosmetic Act.

  1. Purpose

    • GMPs help companies produce safe and effective products while also protecting consumers from harm. Punishments for not following GMP guidelines include product recalls, product seizures, fines and jail.

    Features

    • GMPs set minimum guidelines for sanitation, recordkeeping, employee qualifications and complaint processes. These guidelines are flexible and do not prescribe specific procedures or processes. Instead, they allow manufacturers to design their own procedures that fit within GMP requirements.

    Considerations

    • GMPs are sometimes called CGMPs, which stands for current good manufacturing practices. Since GMPs change with time, manufacturers must always stay up to date with current guidelines.

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