To standardize the quality management of cosmetics production,according to Regulations on the supervision and administration of cosmetics Measures for the supervision and administration of the production and operation of cosmetics Other regulations rules,The State Food and drug administration has organized and formulated Specification for quality management of cosmetics production hereinafter referred to as standard ,It is hereby announced,since2022year7month1Effective as of.
since2022year7month1From the day,Cosmetic registrant Filed by The entrusted production enterprise shall standard It is required to organize the production of cosmetics.2022year7month1Enterprises that have obtained cosmetics production license recently,The hardware conditions such as plant facilities and equipment must be upgraded,Should be from2023year7month1The upgrade and transformation have been completed recently,Make the plant facilities and equipment meet the requirements standard requirement.  
It is hereby announced.

State Food and Drug Administration

2022year1month6day

Specification for quality management of cosmetics production

Chapter I  total be
Article 1  To standardize the quality management of cosmetics production,according to Regulations on the supervision and administration of cosmetics Measures for the supervision and administration of the production and operation of cosmetics Other regulations rules,Develop this specification.

Article 2  This specification is the basic requirement of cosmetic production quality management,Cosmetic registrant Filed by Entrusted production enterprises shall comply with these specifications.
Article 3  Cosmetic registrant Filed by The entrusted production enterprise shall be honest and self disciplined,Establish a production quality management system in accordance with the requirements of this specification,Realize the purchase of cosmetics materials production test keep in storage Control and trace the whole process of sales and recall,Ensure the continuous and stable production of cosmetics that meet the quality and safety requirements.

Chapter II Organization and personnel
Article 4  Cosmetic registrants engaged in cosmetic production activities Filed by Entrusted production enterprise Hereinafter collectively referred to as enterprise Varieties of cosmetics shall be established and produced Number and production license projects, etc,Define quality management Responsibilities and authorities of production and other departments,Types of cosmetics equipped and produced Technicians and inspectors with the appropriate quantity and production license items.
The quality control department of an enterprise shall be established independently,Perform quality assurance and control responsibilities,Participate in all activities related to quality management.
Article 5  Enterprises shall establish a cosmetics quality and safety responsibility system,Specify the legal representative of the enterprise Or principal,The same below Person in charge of quality and safety Head of quality management department Responsibilities of the person in charge of the production department and other positions related to the quality and safety of cosmetics,The personnel of each post shall comply with the requirements of post responsibilities,Perform corresponding cosmetics quality and safety responsibilities level by level.
Article 6  The legal representative is fully responsible for the quality and safety of cosmetics,It should be responsible for providing the necessary resources,Reasonably formulate and organize the implementation of quality policy,Ensure the achievement of quality objectives.
Article 7  The enterprise shall have a person in charge of quality and safety,The person in charge of quality and safety shall be qualified Chemistry chemical industry biology Medical Science pharmacy food Professional knowledge of cosmetics quality and safety such as public health or law,Familiar with relevant laws and regulations Mandatory national standards technical specifications,And have5At least years experience in cosmetics production or quality management.
The person in charge of quality and safety shall assist the legal representative to undertake the following corresponding responsibilities of product quality and safety management and product release
    one Establish and organize the implementation of the enterprise's quality management system,Implement quality and safety management responsibilities,Regularly report the operation of the quality management system to the legal representative
two Decision making on product quality and safety issues and issuance of relevant documents
three Product safety assessment report formula Production process Material supplier Audit management of product labels, etc,And cosmetic registration Review of filing materials Except for entrusted production enterprises
four Material release management and product release
five Monitoring and management of adverse reactions of cosmetics.
The person in charge of quality and safety shall perform his duties independently,Free from interference from other personnel of the enterprise.According to the operation needs of enterprise quality management system,With the written consent of the legal representative,The person in charge of quality and safety may designate other personnel of the enterprise to assist in performing the above responsibilities, except one two Other responsibilities outside.The designated personnel shall have corresponding qualifications and ability to perform their duties,And the time for him to assist in the performance of the above responsibilities Specific matters shall be truthfully recorded,Ensure traceability of assistance in the performance of duties.The person in charge of quality and safety shall supervise the assistance in performing his duties,And the legal liability it shall bear shall not be transferred to the designated person.
Article 8  The person in charge of the quality management department shall be qualified Chemistry chemical industry biology Medical Science pharmacy food Professional knowledge of cosmetics quality and safety such as public health or law,Familiar with relevant laws and regulations Mandatory national standards technical specifications,And have experience in cosmetics production or quality management.The person in charge of the quality management department shall undertake the following responsibilities
    one Review of all documents related to product quality
    two Organize changes related to product quality self-examination Nonconforming product management Adverse reaction monitoring Recall and other activities
    three Quality assurance standard Effective implementation of inspection methods and other quality management procedures
    four Ensure that the necessary verification work is completed,Review and approve validation scheme and report
    five Undertake the release audit of materials and products
    six Evaluate material suppliers
    seven Develop and implement training plans related to production quality management,Ensure that employees receive training appropriate to their job requirements,And meet the requirements of post responsibilities
eight Responsible for other activities related to product quality.
Person in charge of quality and safety The person in charge of the quality management department shall not concurrently serve as the person in charge of the production department.
Article 9  The person in charge of the production department shall have Chemistry chemical industry biology Medical Science pharmacy food Professional knowledge of cosmetics quality and safety such as public health or law,Familiar with relevant laws and regulations Mandatory national standards technical specifications,And have experience in cosmetics production or quality management.The person in charge of the production department shall undertake the following responsibilities
one Ensure that products are registered in accordance with cosmetics The technical requirements specified in the filing materials and the production process procedures and post operation procedures formulated by the enterprise
two Ensure the authenticity of production records complete accuracy Traceability
three Ensure production environment Facilities and equipment meet the needs of production quality
four Ensure that employees directly engaged in production activities are trained,Have the knowledge and skills appropriate to the job requirements
five Responsible for other activities related to product production.
Article 10  An enterprise shall formulate and implement an induction training and annual training plan for employees,Ensure that employees are familiar with job responsibilities,Have legal knowledge of performing post responsibilities Professional knowledge and operation skills,Only after passing the examination can he take the post.
The enterprise shall establish employee training files,Including trainers time content Method and assessment, etc.
Article 11  An enterprise shall establish and implement a health management system for employees.Personnel directly engaged in cosmetics production activities shall receive health examination before taking up their posts,Receive health examination every year after taking the post.Persons suffering from diseases that hinder the quality and safety of cosmetics as stipulated by the competent department of health under the State Council shall not directly engage in cosmetics production activities.An enterprise shall establish health records for its employees,Save at least3year.
The enterprise shall establish and implement a hygiene management system for entering the production workshop Management system for foreign personnel,Not in the production workshop Carry out activities in the laboratory that have an adverse impact on product quality and safety.

Chapter III  Quality assurance and control
Article 12  The enterprise shall establish and improve the documents of cosmetics production quality management system,Including quality policy Quality objectives Quality management system quality standard Product formula Production process specification Operating procedures,And other documents required by laws and regulations.
The enterprise shall establish and implement a document management system,Ensure the formulation of cosmetics production quality management system documents to examine approval grant Destruction, etc. are effectively controlled.
Article 13  All activities related to this specification shall be recorded.
An enterprise shall establish and implement a record management system.The record shall be true complete accuracy,Clear and easy to distinguish,Correlation and traceability,It shall not be changed at will,The correction shall be marked with the name and date of the corrector.
Using computer Electronization System generation To keep records or data,It shall comply with the appendix to this specification1Requirements.
Records shall be clearly marked,Orderly storage,Easy to consult.Records related to product traceability,The storage period shall not be less than after the expiration of the service life of the product1year Insufficient service life of the product1Year,The retention period of records shall not be less than2year.Records not related to product traceability,The storage period shall not be less than2year.If the retention period of records is otherwise specified, such provisions shall prevail.
Article 14  The enterprise shall establish and implement a traceability management system,For raw materials Inner packing material Partially Prepared Products Formulate clear batch number management rules for finished products,All records related to the production of each batch of products shall be interrelated,Ensure material procurement Product production Quality Control keep in storage All activities such as sales and recall can be traced.  
Article 15  The enterprise shall establish and implement a self inspection system for the quality management system,Including self inspection time Self inspection basis Responsibilities of relevant departments and personnel Self inspection procedure Result evaluation, etc.
Before the implementation of self-examination, a self-examination plan shall be formulated,After the self-examination is completed, a self-examination report shall be formed.The self inspection report shall include the problems found Product quality and safety evaluation Rectification measures, etc.The self inspection report shall be approved by the person in charge of quality and safety,Report legal representative,And feed back to relevant departments of the enterprise.The enterprise shall track and evaluate the rectification.
The enterprise shall conduct self inspection on the implementation of the cosmetics production quality management standards every year.Continuous shutdown1More than years,Self inspection shall be conducted before re production,Confirm whether it meets the requirements of this specification The sampling inspection results of cosmetics are unqualified,Self inspection and rectification shall be carried out in time as required.
Article 16  The enterprise shall establish and implement an inspection management system,Formulation of raw materials Inner packing material Quality control requirements for semi-finished products and finished products,Using inspection method as quality control measure,Inspection items The inspection method and frequency shall be consistent with the registration of cosmetics The technical requirements specified in the filing materials are consistent.
The enterprise shall specify the inspection or confirmation method Sampling requirements Sample management requirements Inspection procedures Inspection process management requirements and inspection abnormal result handling requirements, etc,The results of inspection or confirmation shall be true complete accuracy.
Article 17  Enterprises shall establish and produce cosmetics varieties Number of laboratories suitable for production license projects, etc,At least the total number of colonies Inspection ability of microbial inspection items such as total number of molds and yeasts,And ensure the detection environment Inspection personnel and inspection facilities equipment Instruments and reagents culture medium Standard products meet the inspection needs.heavy metal Pathogenic bacteria and other safety risk substances specified in the standards implemented by the product,An inspection and testing institution that has obtained qualification can be entrusted for inspection.
The enterprise shall establish and implement the laboratory management system,Ensure the normal operation of experimental equipment and instruments,Reagents used in the laboratory culture medium Preparation of standard use Scrap and validity period implementation management,Ensure that the inspection results are true complete accuracy.
Article 18  The enterprise shall establish and implement a sample retention management system.Samples shall be kept for each batch of products leaving the factory,The quantity of reserved samples shall at least meet the requirements of delivery inspection2times,And shall meet the requirements of product quality inspection.
The ex factory products are finished products,The retained samples shall be kept in the original sales packaging.The sales package is in the form of box,The sales package contains multiple cosmetics and all are the smallest sales unit,If the sample has been reserved for the smallest sales unit in the package,You can not leave samples for the whole sales package product,However, the outer package of boxes that can meet the requirements of quality traceability shall be retained.
The ex factory products are semi-finished products,The reserved samples shall be sealed and can ensure the stability of product quality,And there are label information that meets the requirements,Guarantee traceability.
The enterprise shall store and retain in accordance with the provisions of relevant laws and regulations and the requirements of labels,s%s.s%s6s%s.s%s,s%s,s%s,s%s.

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