CSAR Subsidiary Regulations: China Clarifies the Requirements for Cosmetics GMP

A cosmetics production quality management system will be established to realize the control and traceability of the entire process of cosmetics material procurement, production, inspection, storage, sales, and recall. Under the premise of ensuring product quality and safety, the enterprise can adopt technical schemes equivalent to the Practices’ requirements and should keep the necessary verification documents and records.

On Sep. 28, 2020, China NMPA released the draft Good Manufacturing Practices (GMP) for Cosmetics for public consultation ^[1]. Any suggestions can be mailed to ChemLinked (cosmetic@chemlinked.com) before Oct. 14, 2020, and we will submit to the NMPA.

Main Contents

CSAR stipulated that cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with the requirements of the Good Manufacturing Practices for Cosmetics. The Practices are divided into nine chapters and two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall.

Chapter I General Rules

Chapter II Institutions and Personnel

Chapter III Quality Management

Chapter IV Quality Control

Chapter V Plant Facilities and Equipment

Chapter VI Ingredients and Products

Chapter VII Production Management

Chapter VIII Product Sales Management

Chapter IX Supplementary Rules

Annex I Electronic Record Requirements for Cosmetics Production

Annex II Environmental Requirements for Cosmetics Production Workshop

Key Points

The Practices' formulation is based on the quality control requirements of Practice for Cosmetics Production Licensing issued in 2015, supplements and refines relevant contents combined with the problems found in regulatory and supervisory practice. The four key points of these Practices are as follows:

1. Establish a Cosmetic Production Quality Management System

Cosmetic registrants, notifiers, and entrusted production enterprises shall establish a cosmetics production quality management system to realize the control and traceability of the entire process of cosmetics material procurement, production, inspection, storage, sales, and recall.

Enterprises' responsibilities include:

Establish and implement management systems such as suppliers selection, ingredients acceptance, equipment management, production process, and quality control, product inspection and sample retention, product sales, record management, traceability management, etc.;