The FDA Draft Guidance for Cosmetic Good Manufacturing Practices (GMPs)

In attempts to harmonize GMPs internationally, the FDA has published a draft guidance for Cosmetic Good Manufacturing Practices (GMPs). This change comes from revisions to the predecessor FDA guidance, Cosmetic Good Manufacturing Guidelines/Inspection Checklist. With this guidance dating back to the early 1990’s, much of this information has become outdated with little consideration to implement ISO 22716 standards.

In September 2007, the International Cooperation on Cosmetic Regulation (ICCR) met with regulators from the United States, Canada, the European Union, and Japan. A decision was made that it would be useful for the cosmetic industry to have a standardized method to apply GMPs to their jurisdictions. The four regulators agreed to take ISO standards into consideration when developing or updating respective guidelines.

Although there are no GMP regulations for cosmetics, this draft guidance has provided a list of GMP criteria to self-inspect operations and proactively prevent adulteration of product.

For further details regarding the guidance, please refer to the link here.

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