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FDA Issues Draft Good Manufacturing Practice Recommendations for Cosmetic Products

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Center for Food Safety and Applied Nutrition - Food and Drug Administration

June 25, 2013

The Food and Drug Administration has issued draft guidance on good manufacturing practices (GMPs) for cosmetic products. This document is intended to assist industry and other stakeholders by identifying standards and issues that can affect the quality and safety of cosmetic products.

The new draft guidance updates FDA’s current “Cosmetic Good Manufacturing Guidelines/Inspection Checklist.” Updates include a new section on definitions, which is intended to clarify terms contained in the guidance, and one on documentation, which notes its role in preventing errors and correcting problems that may occur during manufacture.

The guidance also is part of an effort to align international standards on cosmetic manufacturing. FDA participates in this effort through its work with the International Cooperation on Cosmetics Regulation (ICCR).

The guidance includes specific recommendations on documentation, recordkeeping, buildings and facilities, equipment, personnel, raw materials, production, internal audits, laboratory controls, handling consumer complaints and reports of adverse events, and conducting recalls.

The updated draft guidance is available at: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm353046.htm