FDA publishes new GMP Guide for Cosmetic Products

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. This new draft Guideline includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

The new guidance document revises the existing “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 the FDA intends to harmonize their own requirments with those published by the International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007). However, FDA has only incorporated elements of ISO 22716, as appropriate, and consistent with FDA regulations. Some ISO requirements have not been transfered to the new FDA Guide. But also some additional requirements not included in the ISO 22716 have been incorporated in the guide. The Guide also refers to a Guidance for Industry on Cosmetics Processors and Transporters of Cosmetics Security Preventive Measures which was already revised in October 2007. Different to most other FDA Guidance documents this Guidance for Industry is also available in Dutch, German, French, Arabic, Korean, Thai as well as in Chinese language.

Reference:  June 2013 revision of the Guidance for Industry: Cosmetic Good Manufacturing Practices