Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration Forty first issue
problem1 Cosmetics manufacturing enterprises use it for quality testing Can the stability test sample be used as a factory sample for the same batch of products
answer Quality Management Standards for Cosmetics Production Article 18: Clear regulations have been made on the packaging for leaving samples at the factory,The products that leave the factory are considered finished products,Samples should be kept in their original sales packaging The products that leave the factory are semi-finished products,The retained sample should be sealed.If the enterprise uses it for physical and chemical testing The retained samples for microbiological testing and stability testing do not meet the packaging requirements for the aforementioned factory retained samples,It cannot be used as a factory sample for the same batch of products.
problem2 What are the requirements for retaining samples of key raw materials in cosmetics production enterprises
answer Quality Management Standards for Cosmetics Production Article 30: Provisions,Enterprises should keep samples of key raw materials,And save the sample retention record.The raw materials for sample retention should have labels,At least including the Chinese name or code of the raw material Name of manufacturing enterprise Raw material specifications Storage conditions Usage period and other information,Ensure traceability.The quantity of retained samples should meet the requirements of raw material quality inspection.
problem3 Should the production consistency audit of cosmetics manufacturing enterprises be completed by the production department
answer Implementing the Regulations on Supervision and Management of the Main Responsibility for Cosmetics Quality and Safety in Enterprises Article 17: Provisions,Enterprises should establish a consistency audit system for cosmetics production.The person in charge of quality and safety shall review the formula of the cosmetic products produced before the first production Production process Review and manage product labels and other related content,Form consistency audit records for cosmetics production,And regularly conduct retrospective reviews of relevant content,Ensure that the products produced comply with cosmetics registration Technical requirements stated in the filing documents.The record should include the name of the audited product Registration certificate number for special cosmetics or filing number for ordinary cosmetics Review content, etc.The quality and safety manager discovered the formula of the cosmetic product being produced Production process Existence and registration of product labels and other related content Inconsistent technical requirements or other non-compliance with legal and regulatory requirements stated in the filing materials,Immediate measures such as risk control should be taken by the organization.
problem4 If cosmetic production enterprises adopt inspection methods as quality control measures,How to determine the inspection items Inspection methods and frequency
answer Quality Management Standards for Cosmetics Production Article 16: Provisions,Enterprises should establish and implement inspection management systems,Develop raw materials Internal packaging materials Quality control requirements for semi-finished and finished products,Adopting inspection methods as quality control measures,Inspection items The inspection method and frequency should be consistent with the registration of cosmetics The technical requirements stated in the filing materials are consistent.problem5 What are the requirements for cosmetic production enterprises to submit rectification reports as inspection targets
answer Management Measures for Cosmetics Inspection Article 17: Provisions,The inspected object shall rectify the defects and problems found during the inspection within the prescribed time,And submit the rectification report as required.The rectification report should include the main problems that exist Problem investigation analysis and risk assessment Risk control measures Effect after rectification, etc.
Thoughtful reminder basis Management Measures for Registration and Filing of Cosmetics Article 37,according to The National Medical Products Administration's Implementation<Regulations on the Management of Registration and Filing Materials for Cosmetics>Announcement on Relevant Matters 2021Year's Day35number requirement,since2022year1month1From now on,Ordinary cosmetics registered through the original registration and filing platform and the new registration and filing platform,Unified implementation of annual reporting system,The registrant shall submit it annually1month1Solstice3month31Date interval,Through the new registration and filing platform,Submit an annual report for ordinary cosmetics with a filing period of one year or more.basis Regulations on the Supervision and Management of Toothpaste Article 23 Supervision and management of toothpaste,Not specified in these measures,Reference applicable Management Measures for Registration and Filing of Cosmetics Regulations on the Supervision and Administration of Cosmetics Production and Operation Regulations on waiting. ,Toothpaste filers should also submit annual reports as required.2025year1month1Solstice3month31Day is the window period for a new round of annual reports,Please have the relevant filing personnel promptly carry out annual report work in accordance with regulations.
