Draft Guidance for Industry
Cosmetic Good Manufacturing Practices
February 12, 1997; revised April 24, 2008, and June 2013
This document provides guidance to industry and other stakeholders (e.g., consumer interest groups, academia, other regulatory groups) on FDA’s current thinking concerning what constitutes Good Manufacturing Practices (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.
This guidance revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience. In addition, as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience.
The predecessor to this guidance, FDA’s “Cosmetic Good Manufacturing Guidelines/Inspection Checklist,” was based on documents and information dating before the early 1990’s. Much of the material in the predecessor document has become outdated. In addition, there has been a great deal of progress in developing international consensus standards for cosmetics, specifically ISO 22716 (Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices. ISO 22716:2007. Geneva, Switzerland:ISO.).
ISO is a non-governmental organization that develops and publishes international consensus standards. In September 2007, the International Cooperation on Cosmetic Regulation (ICCR), the quadrilateral international harmonization group, met in Belgium. During that meeting, the regulators from the United States, Canada, the European Union, and Japan agreed that it would be useful for the cosmetic industry to have a standardized scheme for GMPs that could apply to their jurisdictions. As a result, the regulators from these four jurisdictions agreed to take ISO standards for cosmetic GMPs into consideration when developing or updating guidelines or other measures addressing GMPs (See International Cooperation on Cosmetic Regulation: Outcome of Meeting, September 26-28, 2007). In developing this guidance, FDA has incorporated elements of ISO 22716, as appropriate, and consistent with FDA regulations.
Last Updated: 2015-08-14