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FDA Draft Guidance for Industry Cosmetic Good Manufacturing Practices

蒋千琴 3/1/2022 浏览 360 FDA U.S

标准简介

Draft Guidance for Industry Cosmetic Good Manufacturing Practices[附网盘链接]是于过去发布的FDA标准，适用于U.S。

标准截图

Draft Guidance for Industry Cosmetic Good Manufacturing Practices[附网盘链接]
Draft Guidance for Industry Cosmetic Good Manufacturing Practices[附网盘链接](截图)

 

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标准部分原文

Draft-Not for Implementation 1

Guidance for Industry Cosmetic Good Manufacturing Practices This guidance represents the Food and Drug Administration's (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction

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. II. Background

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 1

This guidance has been prepared by the Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

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