Enclosure

Production Quality Management Specification for Cosmetics

Key inspection points and judgment principles

In order to standardize the production license, supervision and inspection of cosmetics, guide the cosmetic registrants, registrants, and entrusted production enterprises to implement the Cosmetic Production Quality Management Standards, the State Food and Drug Administration has organized and formulated the Inspection Points and Judgment Principles of Cosmetic Production Quality Management Standards in accordance with the Cosmetic Supervision and Administration Regulations, the Cosmetic Production and Operation Supervision and Administration Measures and other laws and regulations.

One、 Application scope of inspection points of cosmetics production quality management specification

（1） The cosmetic registrants, registrants and entrusted production enterprises engaged in the production of cosmetics shall be inspected according to the inspection points of the cosmetics production quality management specifications (the actual production version, see Appendix 1). Attachment 1 has 81 inspection items, including 29 key items (including 3 key items and 26 other key items) and 52 general items.

（2） The cosmetic registrants and registrants entrusted for production shall be inspected according to the inspection points of the cosmetic production quality management specifications (entrusted production version, see Appendix 2). Attachment 2 has 24 inspection items, including 9 key items (including 1 key item and 8 other key items) and 15 general items.

（3） For cosmetic registrants and registrants who are both engaged in cosmetic production activities and commissioned to produce cosmetics, they shall be inspected and judged separately according to Appendix 1 and Appendix 2.

Two、 Cosmetics Production Quality Management Norms Inspection Classification and Judgment Principles

Ⅰ、On site inspection of production license

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize on-site inspection of the cosmetics production license applicants according to Appendix 1.

1. If the enterprise is not found to have any nonconforming items in the on-site inspection, it shall be judged as "passed the on-site inspection".

2. If any of the following circumstances is found in the on-site inspection, it shall be judged as "failed on-site inspection":

(1) Non conformance of key items;

(2) The total number of defects of key projects and other key projects that do not meet the requirements is more than 6 (inclusive);

(3) The total number of non conformities of key projects, defects of key projects and non conformities of general projects is more than 16 (inclusive).

3. If the enterprise is found to have items that do not conform to the provisions in the on-site inspection, but there is no such situation that should be judged as "on-site inspection failed", it should be judged as "review after rectification". Enterprises judged as "recheck after rectification" shall complete the rectification within the specified time and submit the rectification report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government. After receiving the rectification report, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government can organize on-site review of the enterprise according to the actual situation. After confirming that the rectification meets the requirements, it will be judged as "on-site inspection passed"; If the rectification report is not submitted within the specified time limit or the rectification items still do not meet the requirements after re inspection, it shall be judged as "failed on-site inspection".

Ⅱ、On site inspection after extension of production license

The drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within 6 months from the date of issuing a new cosmetic production license to the applicant for renewal of the cosmetic production license, supervise the applicant's application materials and commitments for renewal of the license, and organize on-site inspection of the enterprise according to Appendix 1. If the inspection result is that the above "on-site inspection fails", the cosmetic production license shall be revoked according to law; If the verification result is the above-mentioned "review after rectification", and the rectification report is not submitted within the specified time limit, or the rectification items are still found to be not in conformity with the provisions, the cosmetics production license shall be revoked according to law.

Ⅲ、Daily supervision and inspection

1. Supervise and inspect the cosmetic registrants, registrants and entrusted manufacturers engaged in cosmetic production activities

The department in charge of drug supervision and administration shall carry out supervision and inspection of all or part of the projects according to Appendix 1 on the implementation of the production quality management specifications of enterprises that have obtained the production license for cosmetics.

(1) If the enterprise is not found to have any nonconforming items in the on-site inspection, it shall be judged as "no defects in the production quality management system are found in the inspection".

(2) If one of the following circumstances is found in the on-site inspection, it shall be judged as "serious defects exist in the production quality management system":

1) Non conformance of key items;

2) The total number of defects of key projects and other key projects that do not meet the requirements is more than 6 (inclusive);

3) The total number of non conformities of key projects, defects of key projects and non conformities of general projects is more than 16 (inclusive).

(3) If the enterprise is found to have items that do not conform to the provisions in the on-site inspection, but there is no such situation that should be judged as "serious defects exist in the production quality management system", it should be judged as "defects exist in the production quality management system".

2. Supervise and inspect the registrants and registrants of cosmetics commissioned for production

The department in charge of drug supervision and administration shall carry out supervision and inspection of all or part of the project according to Appendix 2 on the implementation of the production quality management specifications of the cosmetic registrants and registrants entrusted to manufacture.

(1) If the enterprise is not found to have any nonconforming items in the on-site inspection, it shall be judged as "no defects in the production quality management system are found in the inspection".

(2) If one of the following circumstances is found in the on-site inspection, it shall be judged as "serious defects exist in the production quality management system":

1) Non conformance of key items;

2) The total number of defects of key projects and other key projects that do not meet the requirements is more than 4 (inclusive);

3) The total number of non conformities of key projects, defects of key projects and non conformities of general projects is more than 8 (inclusive).

(3) If the enterprise is found to have items that do not conform to the provisions in the on-site inspection, but there is no such situation that should be judged as "serious defects exist in the production quality management system", it should be judged as "defects exist in the production quality management system".

Three、 Other matters

The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government may, in light of actual conditions, refine and supplement the inspection points of the norms for the quality control of cosmetics production in their respective administrative regions.

Attachment: 

1. Inspection Points of Cosmetic Production Quality Management Specifications (Actual Production Version)

2. Inspection points of cosmetics production quality management specifications (commissioned production version)