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Factory Qualifications

U.S. FDA Cosmetic GMP

Definition

FDA Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics

The U.S. FDA publishes Cosmetic GMP Guidelines/Inspection Checklist to guide and inspect cosmetic manufacturers' production and quality management practices concerning premises, personnel, equipment, raw materials, production, laboratory controls and records. FDA states that strict adherence to GMP helps reduce the risk of adulteration or misbranding of cosmetics.[1] FDA itself does not operate an official ‘FDA Cosmetic GMP Certificate’ certification program and does not directly issue a GMP certificate simply because a company follows these guidelines.

However, third-party auditing and certification bodies may audit factories against FDA's Cosmetic GMP Guidelines and issue their own GMP certificates after confirming that management systems and manufacturing practices meet the relevant requirements. For example, VINNER Health has been audited by Intertek against the Cosmetic Good Manufacturing Practice Guidelines (2022) published by the U.S. FDA and has obtained a certificate issued by Intertek.

Why does it matter?

For cosmetics and personal care products intended for the U.S. market, an independent third-party audit against FDA Cosmetic GMP guidance can help customers assess a factory's maturity in hygiene, production control, quality control and record management, even when a procurement project does not require a particular third-party GMP certificate.

References

  1. [1]U.S. Food and Drug Administration (FDA), Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics.
  2. [2]VINNER Health Huanggang Branch, Cosmetic GMP Certificate issued by Intertek — assessed against Cosmetic Good Manufacturing Practice Guidelines (2022) published by U.S. FDA.

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  • U.S. FDA Cosmetic GMP

    The U.S. FDA publishes Cosmetic GMP Guidelines/Inspection Checklist to guide and inspect cosmetic manufacturers' production and quality management practices concerning premises, personnel, equipment, raw materials, production, laboratory controls and records. FDA states that strict adherence to GMP helps reduce the risk of adulteration or misbranding of cosmetics.

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