Cosmetic Good Manufacturing Practices Guidance

  • By: Staff Editor
  • Date: November 27, 2016
  • Source:
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Cosmetic Good Manufacturing Practices Guidance

The FD&C Act prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded.

Tampering and other malicious or unlawful activity present additional risks that can also have a direct impact on products’ quality. To help minimize these risks to cosmetics, FDA recommends to consult a separate FDA guidance document entitled “Guidance for Industry: Cosmetic Processors and Transporters of Cosmetics Security Preventive Measures Guidance.

This FDA Guidance is proposed to aid industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products. The 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.

Summary of Requirements

The Guidance details the requirements for:

  • Documentation
  • Records
  • Buildings and Facilities
  • Equipment
  • Personnel
  • Raw Materials
    • Water
    • Color Additives
    • Prohibited and Restricted Cosmetic Ingredients
  • Production
  • Laboratory Controls
  • Internal Audit
  • Complaints, Adverse Events, and Recalls

Related Training:

FDA Regulations and New Legislation for Marketing Cosmetics in the U.S.

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