In order to standardize the production license and supervision and inspection of cosmetics, and guide the cosmetics registrants, filers, and entrusted production enterprises to implement the "Cosmetics Production Quality Management Standards", in accordance with the "Cosmetics Supervision and Administration Regulations" and "Supervision and Administration Measures on Cosmetics Manufacture and Operation" and other regulations, Regulations, the NMPA organized and formulated the " Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices ", which are hereby published and will come into force on December 1, 2022. The relevant matters are hereby announced as follows:
First, the department responsible for medical products supervision and administration based on "Good Manufacturing Practices for Cosmetics " " Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices" of cosmetics registrants, filers, entrusted production enterprises (hereinafter collectively referred to as "enterprises") to carry out inspections, and make a comprehensive determination according to the implementation of " Good Manufacturing Practices for Cosmetics " of enterprises.
Second, the inspection determined that the " production quality management system with defect " in the enterprise, the department responsible for medical products supervision and administration should urge the enterprise to complete rectification within the specified time and submit a rectification report, if necessary, it can organize on-site review. Slight illegal act with no harm caused by the consequences, rectification in line with the “Good Manufacturing Practices for Cosmetics" requirements, according to law, there will be no administrative penalty.
Third, the inspection determined that the "production quality management system with serious defects" of the enterprise, the department responsible for medical products supervision and administration should take orders to suspend production, operation and other emergency control measures to control the risk of products in a timely manner based on "CSAR" Article 54. The enterprise should complete the rectification within the specified time, and submit a rectification report. The medical products supervision and administration departments responsible for the enterprise should carry out on-site review, to confirm that the rectification meets the requirements before resuming its production, operation.
Fourth, the inspection determined that the "production quality management system with serious defects" of the enterprise, the department responsible for medical products supervision and administration should implement an investigation based on the "CSAR" Article 60 (3), " Supervision and Administration Measures on Cosmetics Manufacture and Operation" Article 59 and etc.
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