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          Draft Guidance for Industry: Cosmetic Good Manufacturing PracticesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
					
		
		June 2013


	Download the  Draft  Guidance Document 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition, Office of Cosmetics and Colors


What's New

May 3, 2023

FDA intends to withdraw or revise and reissue this draft guidance as appropriate, based on the GMP rulemaking required by the Modernization of Cosmetics Regulation Act of 2022. See also Public Meeting: Good Manufacturing Practices for Cosmetic Products - 06/01/2023.


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.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance


 
	Submit Comments
	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      05/03/2023
         
                  
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