CSAR Subsidiary Regulations: China NMPA Consults on the Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices

On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. ¹ Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA ([email protected]) before April 20, 2022.

The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.

Main Contents

There are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.

Applicable Scope

The applicable scope of the Points is divided into the following three categories,

• For cosmetic registrants, notifiers, and entrusted production enterprises engaged in production activities (hereinafter referred to as “manufacturing enterprises”): regulatory authorities will conduct on-site inspections in accordance with Annex I. There are 82 inspection items in total, including 5 core items, 24 key items, and 53 general items.

• For cosmetics registrants and notifiers who entrust production enterprises to produce cosmetics (hereinafter referred to as “entrusting enterprises”): regulatory authorities will conduct on-site inspections in accordance with Annex II. There are 24 inspection items in total, including 2 core items, 7 key items, and 15 general items.

• For cosmetic registrants and notifiers who are engaged in both self-production activities and entrusted production activities: regulatory authorities will conduct on-site inspections in accordance with Annex I and Annex II.

This is also the first time NMPA has proposed conducting a separate inspection for the entrusting enterprises, which will be a challenge for them.

Judgment Principles

The following are the principles for judging whether an enterprise complies with GMP. The judgment principles are based on the severity and proportion of non-compliant items, a scientific supervision method.

It is worth noting that if one core item is not compliant, the enterprise's production license will be revoked, or the enterprise will be punished. The supervision for non-compliance behaviors will be more stringent.

Inspection Points

The inspection points are divided into two versions, one for manufacturing enterprises and the other for entrusting enterprises.

• The inspection points for manufacturing enterprises cover six major parts: departments and personnel, quality assurance and control, plant facility and equipment management, material and product management, production process management, and product sales management;

• The inspection points for the entrusting enterprises center on the person in charge of quality and safety, the quality management system and the quality control system.

Core Inspection Items

Enterprises need to pay special attention to the following core inspection items. If one core item is not compliant, the enterprise’s production license will be revoked, or the enterprises will be punished. These items are also the key elements of the entire quality management system.

Person in Charge of Quality and Safety is the Key Inspection Item

The Points clarifies 15 inspection items related to the person in charge of quality and safety. There is no doubt that it will be the focus of the regulatory authorities when conducting GMP inspections.

Inspection Items related to the Person in Charge of Quality and Safety (Extract):

• whether the enterprise has a person in charge of quality and safety;

• whether the person in charge of quality and safety has the corresponding qualifications;

• whether the person in charge of quality and safety performs duties independently in accordance with regulations;

• if another person is designated to perform the duties on behalf of the person in charge of quality and safety, whether the person has obtained the written consent from the legal person;

• whether the designated person has the corresponding qualifications.

Industry Comments

According to a cosmetic media Qingyan ², the Points clarifies that both manufacturing enterprises and entrusting enterprises must be responsible for the production and quality of cosmetics. It also clearly regulates the enterprises’ production activities in detail, and help regulatory authorities across China unify the enforcement standards.

In the Points, there are relatively strict requirements for the entrusting enterprise, such as

• setting up a person in charge of quality and safety;

• establishing a supervision system for the entrusted production enterprises;

• ensuring that the entrusted production enterprise meets the production conditions, and compiling supervision records;

• establishing a quality management system, the files of registered and notified products, an adverse reaction monitoring and evaluation system, etc. 

These requirements can be very challenging for entrusting enterprises with no relevant management experience before, but may have less impact on the manufacturing enterprises. "After all, the previous Practice for Cosmetics Production Licensing was implemented in 2016, which means manufacturing enterprises have accumulated 7 years of experience and are more familiar with these requirements,” Said an industry insider.

Further Reading

• Breaking! China to Release the Safety and Technical Standard for Cosmetics 2022 (STSC 2022)

• 4 Authoritative Replies from NMPA: Explicit Guidelines on Cosmetic Supervision and Administration

• China NIFDC Consults on Limitation of Benzene in Cosmetics