The FDA Issues an Updated Draft GMP Guidance for Cosmetics

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July 10, 2013 - Mujadala Abdul-Majid

The Food and Drug Administration (FDA) on 25 June 2013 published revisions to a draft guidance on good manufacturing practices (GMPs) for cosmetic products. The guidance is to share the FDA’s current thinking concerning what constitutes GMPs for cosmetics. It is intended to assist industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products.

The draft revises the FDA’s current Cosmetic Good Manufacturing Guidelines/Inspection Checklist and includes two new sections: one on definitions and another on documentation and recordkeeping, which focuses on preventing errors and correcting problems during manufacture. When revising the guidance, the agency considered the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007). The FDA reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on the agency’s experience.

The revision is part of an effort by the FDA within the framework of the International Cooperation on Cosmetics Regulation (ICCR), a voluntary partnership among the health authorities of Canada, Europe, Japan, and the U.S., with participation and technical support from the cosmetics industry associations of the four jurisdictions.

The prior version of the guidance was based on outdated information that was available prior to the 1990s. This version is to reflect the great deal of progress in developing international consensus standards for cosmetics, specifically ISO 22716. This will not provide any added enlightenment for manufacturers who were already in conformance with the international standard. For others, it creates an opportunity to adhere to a more harmonized quality manufacturing standard.