Good Manufacturing Practice for Cosmetics

Chapter 1 General Provisions

Article 1 In order to standardize the quality management of cosmetics production, this specification is formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics", "Regulations on the Supervision and Administration of Cosmetics Production and Operation" and other laws and regulations. Article 2 This specification is the basic requirement for the quality management of cosmetics production, and cosmetics registrants, recorders, and entrusted production enterprises shall comply with this specification. 

Article 2 Cosmetics registrants, recorders, and entrusted production enterprises shall be honest and self-disciplined, establish a production quality management system in accordance with the requirements of this specification, and realize the control and traceability of the entire process of cosmetics material procurement, production, inspection, storage, sales and recall, so as to ensure the continuous and stable production of cosmetics that meet quality and safety requirements.

Chapter 2 Organizations and Personnel

Article 4 Cosmetics registrants, recorders, and entrusted production enterprises (hereinafter collectively referred to as "enterprises") engaged in cosmetics production activities shall establish organizational structures that are consistent with the types, quantities, and production license items of cosmetics produced, clarify the duties and powers of quality management, production and other departments, and equip technical personnel and inspection personnel that are consistent with the types, quantities, and production license items of cosmetics produced.

The quality management department of an enterprise shall be set up independently, perform quality assurance and control duties, and participate in all activities related to quality management. 

Article 5 Enterprises shall establish a cosmetics quality and safety responsibility system, clarify the job list of the enterprise's legal representative (or principal person in charge, hereinafter the same), quality and safety person in charge, person in charge of the quality management department, person in charge of the production department and other positions related to cosmetics quality and safety, and personnel in each position shall perform the corresponding cosmetics quality and safety responsibilities step by step in accordance with the requirements of the job list.

Article 6 The legal representative shall be fully responsible for the quality and safety of cosmetics, and shall be responsible for providing necessary resources, reasonably formulating and organizing the implementation of quality policies, and ensuring the achievement of quality goals.

Article 7 An enterprise shall appoint a person in charge of quality and safety. The person in charge of quality and safety shall have professional knowledge related to cosmetics quality and safety, such as cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health or law, and shall be familiar with relevant laws and regulations, mandatory national standards and technical specifications, and have more than 5 years of experience in cosmetics production or quality management. The person in charge of quality and safety shall assist the legal representative in assuming the following corresponding product quality and safety management and product release responsibilities:

• Establish and organize the implementation of the enterprise's quality management system, implement quality and safety management responsibilities, and regularly report to the legal representative on the operation of the quality management system;

• Decision-making on product quality and safety issues and issuance of relevant documents:

• Review and management of product safety assessment reports, formulas, production processes, material suppliers, product labels, etc., as well as the review of cosmetics registration and filing materials (except for entrusted production enterprises);

• Material release management and product release:

• Cosmetics adverse reaction monitoring management

The person in charge of quality and safety shall perform his duties independently without interference from other personnel of the enterprise. According to the needs of the operation of the enterprise's 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 other duties except (1) and (2) among the above duties. The designated personnel shall have the corresponding qualifications and ability to perform their duties, and the time and specific matters of their assistance in performing the above duties shall be recorded truthfully to ensure that the assistance in performing duties can be traced. The person in charge of quality and safety shall supervise the assistance in performing duties, and the legal responsibilities he should bear shall not be transferred to the designated personnel.

Article 8 The person in charge of the quality management department shall have professional knowledge related to cosmetics quality and safety, such as cosmetics, chemistry, chemical biology, medicine, pharmacy, food, public health or law, be 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 duties:

• Review all documents related to product quality;

• Organize changes, self-inspections, non-conforming product management, adverse reaction monitoring, recall and other activities related to product quality;

• Ensure the effective implementation of quality standards, Inspection methods and other quality management procedures;

• Ensure the completion of necessary verification work, review and approve verification plans and reports;

• Undertake the release review of materials and products;

• Evaluate material suppliers;

• Formulate and implement training plans related to production quality management to ensure that employees receive training that is appropriate to their job requirements and meet the requirements of their job responsibilities;

• In charge of other activities related to product quality.

The person in charge of quality and safety and 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 professional knowledge related to cosmetics quality and safety, such as cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health or law, be familiar with relevant laws and regulations, mandatory national standards and technical specifications, and have experience in cosmetics production or quality management. The person in charge of the production department shall assume the following responsibilities:

• Ensure that the products are produced in accordance with the technical requirements stated in the registration and filing materials of cosmetics and the production process procedures and job operation procedures formulated by the enterprise;

• Ensure that the production records are true, complete, accurate and traceable;

• Ensure that the production environment, facilities and equipment meet the production quality requirements;

• Ensure that the employees directly engaged in production activities have been trained and have the knowledge and skills corresponding to their job requirements;

• Be responsible for other activities related to product production.

Article 10 Enterprises shall formulate and implement employee induction training and annual training plans to ensure that employees are familiar with their job responsibilities, have the legal knowledge, professional knowledge and operational skills to perform their job duties, and can only take up their posts after passing the assessment.

Enterprises shall establish employee training files, including training personnel, time, content, methods and assessment results. 

 Article 11 Enterprises shall establish and implement a health management system for employees. Personnel directly engaged in cosmetics production activities shall undergo a health examination before taking up their posts and undergo a health examination every year after taking up their posts. Personnel suffering from diseases that are harmful to the quality and safety of cosmetics as specified by the health authorities of the State Council shall not directly engage in cosmetics production activities. Enterprises shall establish health records for employees and keep them for at least 3 years.

Enterprises shall establish and implement a hygiene management system for entering the production workshop and a management system for outsiders, and shall not carry out activities that have an adverse impact on product quality and safety in the production workshop or laboratory.

Chapter 3 Quality Assurance and Control

Article 12 Enterprises shall establish and improve the quality management system documents for cosmetic production, including quality policy, quality objectives, quality management system, quality standards, product formula, production process procedures, operating procedures, and other documents required by laws and regulations.

Enterprises shall establish and implement a document management system to ensure that the formulation, review, approval, issuance, and destruction of the quality management system documents for cosmetic production are effectively controlled.

Article 13 All activities related to this specification shall be recorded.

Enterprises shall establish and implement a record management system. Records shall be true, complete, accurate, clear and easy to identify, interrelated and traceable, and shall not be changed at will. Corrections shall be marked and the name and date of the person making the correction shall be signed.

The use of computer (Electronic) systems to generate and save records or data shall comply with the requirements of Appendix 1 to this specification. Records shall be clearly marked, stored in an orderly manner, and easy to access. The retention period of records related to product traceability shall not be less than 1 year after the expiration of the product's use period; if the product's use period is less than 1 year, the record retention period shall not be less than 2 years. The retention period of records not related to product traceability shall not be less than 2 years. There are other rules for record retention periods.

Article 14 Enterprises shall establish and implement a traceability management system, formulate clear batch management rules for raw materials, inner packaging materials, semi-finished products, and finished products, and all records related to the production of each batch of products shall be interrelated to ensure that all activities such as material procurement, product production, quality control, storage, sales and recall are traceable. 

Article 15 Enterprises shall establish and implement a self-inspection system for the quality management system, including self-inspection time, self-inspection basis, relevant departments and personnel positions, self-inspection procedures, and result evaluation. Before the implementation of the self-inspection, a self-inspection plan shall be formulated, and a self-inspection report shall be formed after the self-inspection is completed. The self-inspection report shall include the problems found, product quality and safety evaluation, and rectification measures. The self-inspection report shall be approved by the person in charge of quality and safety, reported to the legal representative, and fed back to the relevant departments of the enterprise. The enterprise shall conduct follow-up evaluation of the rectification. Enterprises shall conduct self-inspection on the implementation of cosmetic production quality management specifications every year. If there is a continuous suspension of production for more than one year, self-inspection shall be conducted before re-production to confirm whether it meets the requirements of this specification; if the sampling inspection results of cosmetics are unqualified, self-inspection shall be carried out in a timely manner and rectification shall be carried out in accordance with the regulations. 

Article 16 Enterprises shall establish and implement inspection management systems, formulate quality control requirements for raw materials, inner packaging materials, semi-finished products and finished products, and if inspection methods are used as quality control measures, the inspection items, inspection methods and inspection frequency shall be consistent with the technical requirements stated in the registration and filing materials of cosmetics. Enterprises shall clarify the inspection or confirmation methods, sampling requirements, sample management requirements, inspection operating procedures, inspection process management requirements and inspection abnormal result handling requirements, etc. The inspection or confirmation results shall be true, complete and accurate.

Article 17 Enterprises shall establish laboratories that are suitable for the types, quantities and production license items of cosmetics produced, and at least have the inspection capabilities of microbial inspection items such as total colony count, total number of toxic bacteria and yeast, and ensure that the inspection environment, inspection personnel, inspection facilities, equipment, instruments and reagents, culture media, standard products, etc. meet the inspection needs. Heavy metals, pathogenic bacteria and other safety risk substances specified in the standards implemented by the product can be inspected by qualified inspection and testing institutions. Enterprises shall establish and implement laboratory management systems to ensure the normal operation of laboratory equipment and instruments, manage the preparation, use, scrapping and validity period of reagents, culture media and standard products used in the laboratory, and ensure that the inspection results are true, complete and accurate.

Article 18 Enterprises shall establish and implement sample retention management systems. Samples shall be retained for each batch of products shipped out of the factory, and the number of retained samples shall be at least twice the number required for factory inspection, and shall meet the requirements of product quality inspection. If the product shipped out of the factory is a finished product, the retained sample shall be kept in the original sales packaging. If the sales packaging is in the form of a set box, and the sales packaging contains multiple cosmetics and all of them are the smallest sales units, if the smallest sales unit in the packaging has been sampled, the sales packaging product as a whole may not be retained, but the outer packaging of the set box that can meet the quality traceability requirements shall be retained. If the product shipped out of the factory is a semi-finished product, the retained sample shall be sealed and can ensure the stability of product quality, and have label information that meets the requirements to ensure traceability. Enterprises shall store samples of products in accordance with the provisions of relevant laws and regulations and the requirements of labeling, and keep records of samples. The storage period of samples shall not be less than 6 months after the expiration of the product's use period. If it is found that the sampled product has deteriorated during the use period, the enterprise shall promptly analyze the cause and recall the batch of cosmetics that have been put on the market in accordance with the law to actively eliminate safety risks.

Chapter 4 Factory Facilities and Equipment Management

Article 19 Enterprises shall have production sites and facilities and equipment that are suitable for the variety, quantity and production license items of cosmetics produced. The site selection of production sites shall not be affected by toxic. Harmful places and other pollution sources, and the building structure, production workshops and facilities and equipment shall be easy to clean, operate and maintain.

Article 20 Enterprises shall set up production workshops in accordance with production process and environmental control requirements, and shall not change the functional area division of production workshops without authorization. There shall be no pollution sources in the production workshop, and the flow of materials, products and personnel shall be reasonable to avoid pollution and cross-contamination. The locker room of the production workshop shall be equipped with wardrobes and shoe cabinets, and the clean area and quasi-clean area shall be equipped with non-hand contact hand washing and disinfection facilities. Enterprises shall set up secondary locker rooms according to the needs of production environment control.

Article 21 Enterprises shall divide the production workshop into clean area, quasi-clean area and general production area according to the product process environment requirements, and the production workshop environmental indicators shall comply with the requirements of Appendix 2 of this specification. Areas of different clean levels shall be physically isolated, and the corresponding pressure difference shall be maintained according to the process quality assurance requirements. The production workshop shall maintain good ventilation and appropriate temperature and humidity. According to the production process requirements, purification and disinfection measures shall be taken in the clean area, and disinfection measures shall be taken in the quasi-clean area. Enterprises shall formulate environmental monitoring plans for clean areas and quasi-clean areas, conduct regular monitoring, and inspect the production workshop every year according to the environmental requirements of cosmetics production workshops. 

Article 22 The production workshop shall be equipped with facilities to prevent mosquitoes, flies, insects, rats and other animals from entering and growing, and shall be effectively monitored. Storage areas for materials, products, etc. shall be equipped with appropriate lighting, ventilation, rodent-proof, insect-proof, dust-proof, moisture-proof and other facilities, and equipped with temperature, humidity adjustment and monitoring facilities according to the characteristics of materials and products. Production workshops and other places shall not store or produce materials, products or other items that have an adverse effect on the quality and safety of cosmetics. 

Article 23 Production processes that are prone to generate dust and are difficult to clean shall be completed in separate production operation areas, using dedicated production equipment and taking appropriate cleaning measures to prevent cross contamination. Operation areas for production processes that are prone to generate dust and use volatile substances shall be equipped with effective dust removal or exhaust facilities. 

 Article 24 Enterprises shall be equipped with equipment that is compatible with the types, quantities, production license items, and production process of the cosmetics produced, and equipment related to product quality and safety shall be assigned unique numbers. The design and installation of pipelines shall avoid dead ends, blind pipes, or contamination. Fixed pipelines shall clearly indicate the name of the contents or the purpose of the pipeline, and indicate the flow direction.

The materials of all equipment, utensils, pipelines, etc. that come into contact with raw materials, inner packaging materials, and products shall meet the use requirements and shall not affect product quality and safety. 

Article 25 Enterprises shall establish and implement a production equipment management system, including the procurement, installation, confirmation, use, maintenance, cleaning, and other requirements for production equipment, and regularly verify or calibrate key scales, measuring instruments, meters, and instruments.

Enterprises shall establish and implement procedures for the use of major production equipment. Equipment status identification and cleaning and disinfection identification shall be clear. Enterprises shall establish and implement cleaning and disinfection operating procedures for production equipment, pipelines, containers and utensils. The selected lubricants, cleaning agents and disinfectants shall not cause pollution or corrosion to materials, products or equipment and utensils.

Article 26 The design, installation, operation and maintenance of the water production, water storage and transportation systems of enterprises shall ensure that the process water meets the quality standards.

Enterprises shall establish and implement a system for regular cleaning, disinfection, monitoring and maintenance of water treatment systems.

Article 27 The design, installation, operation and maintenance of the air purification system of enterprises shall ensure that the production workshop meets the environmental requirements.

Enterprises shall establish and implement a system for regular cleaning, disinfection, monitoring and maintenance of air purification systems.

Chapter 5 Material and Product Management

Article 28 Enterprises shall establish and implement a material supplier selection system and conduct audits and evaluations on material suppliers. Enterprises shall sign purchase contracts with material suppliers and specify the material Acceptance standards and quality responsibilities of both parties in the contracts.

Enterprises shall establish a list of qualified material suppliers based on the results of the audit and evaluation, specify key raw material suppliers, and conduct key audits on key raw material suppliers. On-site audits shall be conducted when necessary.

Article 29 Enterprises shall establish and implement a material review system, establish a list of raw materials, purchased semi-finished products and inner packaging materials, specify the ingredients of raw materials and purchased semi-finished products, and retain necessary information related to the quality and safety of raw materials, purchased semi-finished products and inner packaging materials. Enterprises shall review raw materials, purchased semi-finished products and inner packaging materials before purchasing materials, and shall not use banned raw materials or new raw materials that have not been registered or filed, and shall not use restricted raw materials beyond the scope of use and restrictions, and ensure that raw materials, purchased semi-finished products and inner packaging materials comply with the requirements of laws, regulations, mandatory national standards and technical specifications. 

Article 30 Enterprises shall establish and implement a material purchase inspection record system, establish and implement material acceptance procedures, and specify material acceptance standards and acceptance methods. Enterprises shall inspect or confirm the incoming materials in accordance with the material acceptance procedures to ensure that the materials actually delivered are consistent with the purchase contract and delivery ticket and meet the material quality requirements. Enterprises shall keep samples of key raw materials and keep sample records. The retained raw materials shall be labeled with at least the Chinese name of the raw material or the raw material code, the name of the manufacturer, the raw material specifications, storage conditions, expiration date and other information to ensure traceability. The number of samples retained shall meet the requirements of raw material quality inspection. 

Article 31 Materials and products shall be stored under the prescribed conditions to ensure stable quality. Materials shall be classified and placed in batches and clearly marked. If the material name is marked with a code, a code comparison table shall be formulated, and the raw material code shall clearly indicate the corresponding Chinese name of the raw material standard. 

Article 32 Enterprises shall establish and implement a material release management system to ensure that materials can be used for production only after release. Enterprises shall establish and implement procedures for handling unqualified materials. Materials that have exceeded their expiration date shall be managed as unqualified products. 

Article 33 The quality and quantity of water used in production by enterprises shall meet production requirements, and the water quality shall at least meet the requirements of drinking water hygiene standards. If the production water is supplied by a small centralized water supply or a decentralized water supply, the production water shall be tested by a qualified inspection and testing agency at least once a year. Enterprises shall establish and implement process water quality standards and process water management procedures, and regularly monitor the quality of process water to ensure that it meets the production quality requirements. 

 Article 34 Products shall comply with relevant laws and regulations, mandatory national standards, technical specifications and technical requirements specified in the registration and filing materials for cosmetics. Enterprises shall establish and implement a label management system, review and confirm product labels, and ensure that product labels comply with the requirements of relevant laws and regulations, mandatory national standards and technical specifications. The production process of labeling on the inner packaging material shall be completed in the production enterprise that completes the last production process that contacts the contents of the cosmetics. The expiration date marked on the product sales packaging shall not be changed without authorization.

Chapter 6 Production Process Management 

Article 35 Enterprises shall establish and implement a production management system that is compatible with the types, quantities and production license items of the cosmetics produced. 

Article 36 Enterprises shall establish and implement product production process procedures and job Operation procedures in accordance with the technical requirements specified in the registration and filing materials for cosmetics to ensure that products are produced in accordance with the technical requirements specified in the registration and filing materials for cosmetics. The enterprise shall clarify the production process parameters and key control points of the process, and the main production process shall be verified to ensure that qualified products can be produced continuously and stably.

Article 37 The enterprise shall issue production instructions according to the production plan. The production instructions shall include the product name, production batch number (or a unique identifier that can be associated with the production batch number), product formula, total production volume, production time and other contents.

The production department shall produce according to the production instructions. The person who receives the materials shall check the packaging and label information of the materials received and write the receipt for the materials. 

Article 38 The enterprise shall confirm the production workshop, equipment, utensils and materials before the start of production to ensure that they meet the production requirements. Before using the inner packaging materials, the enterprise shall clean and disinfect them according to the cleaning and disinfection operating procedures, or confirm their hygienic compliance. 

Article 39 The enterprise shall clearly mark the materials and semi-finished products used in the production process throughout the process, indicating the name or code, production date or batch number, quantity, and shall be traceable. 

Article 40 The enterprise shall control the production process in accordance with the production process procedures and job operation procedures, and shall write production records truthfully, completely and accurately. Production records shall at least include production instructions, material collection, weighing, preparation, filling or filling, packaging, product inspection and release. 

Article 41 After production, the enterprise shall check the material level and confirm that the material level meets the limit range set by the production process specification. If it exceeds the limit range, the cause shall be found out and confirmed that there is no potential quality risk before entering the next process.

Article 42 After production, the enterprise shall clean up the site in time, clean and disinfect the production workshop and production equipment, pipelines, containers, utensils, etc. in accordance with the operating procedures and record them. After cleaning and disinfection, it shall be clearly marked and the validity period shall be indicated in accordance with regulations. 

Article 43 The enterprise shall return the remaining materials of production to the warehouse in time. The returned materials shall be sealed and marked, and repackaged if necessary. The warehouse management personnel shall check the name or code, production date or batch number, quantity, etc. of the returned materials according to the return material documents. 

Article 44 The enterprise shall establish and implement a non-conforming product management system and analyze the reasons for non-conformity in a timely manner. The enterprise shall prepare rework control documents. Defective products can only be reworked if they are confirmed to be reworkable after evaluation. The destruction and rework of defective products shall be approved and recorded by the quality management department. The enterprise shall stipulate the use period of semi-finished products. If they are not filled or refilled after the use period, they shall be promptly treated as defective products. 

Article 45 The enterprise shall establish and implement a product release management system to ensure that the product is released only after it has passed the inspection and the relevant production and quality activity records have been reviewed and approved. Cosmetics sold on the market shall be accompanied by a product quality inspection certificate in the form of a factory inspection report or a qualified mark.

Chapter 7 Entrusted Production Management

Article 46 The registrant and recorder of entrusted production of cosmetics (hereinafter referred to as the "entruster") shall establish a corresponding quality management system in accordance with the provisions of this specification and supervise the production activities of the entrusted production enterprise.

Article 47 The entruster shall establish an organizational structure that is compatible with the registered or registered cosmetics and the needs of entrusted production, clarify the responsible departments and positions of key links such as registration and filing management, production quality management, and product sales management, and equip corresponding management personnel. 

Article 48 Where cosmetics are produced by entrustment, the entrusting party shall be the registrant or recorder of the cosmetics produced. The entrusted production enterprise shall be an enterprise holding a valid cosmetics production license and accept the entrustment within the scope of its production license.

Article 49 The entrusting party shall establish a cosmetics quality and safety responsibility system, clarify the job list of the entrusting party’s legal representative, the person in charge of quality and safety, and other positions related to cosmetics quality and safety, and the personnel of each position shall perform the corresponding cosmetics quality and safety responsibilities step by step in accordance with the requirements of the job list. 

Article 50 The entrusting party shall set up a person in charge of quality and safety in accordance with the provisions of the first paragraph of Article 7 of this specification.

The person in charge of quality and safety shall assist the legal representative of the entrusting party in assuming the following corresponding product quality and safety management and product release responsibilities:

• Establish and organize the implementation of the enterprise's quality management system, implement quality and safety management responsibilities, and regularly report the operation of the quality management system to the legal representative;

• Decision-making on product quality and safety issues and issuance of relevant documents;

• Review of cosmetic registration and filing materials:

• Review and management of material suppliers and material release for materials purchased and provided by the entrusting party:

• Product marketing release:

• Supervision and management of the selection and production activities of the entrusted production enterprise:

• Cosmetic adverse reaction monitoring management.

The person in charge of quality and safety shall comply with the relevant provisions of the third paragraph of Article 7. 

Article 51 The entrusting party shall establish the selection criteria for the entrusted production enterprise, and before entrusting production, review the qualifications of the entrusted production enterprise, examine and evaluate the operation status of its production quality management system and production capacity, and ensure that the entrusted production enterprise obtains the corresponding cosmetic production license and has the corresponding product production capacity. The entrusting party shall establish a list of entrusted production enterprises and management files.

Article 52 The entrusting party shall sign a contract for entrusted production with the entrusted production enterprise, clarify the entrusted matters, entrustment period, and quality and safety responsibilities of both parties, and ensure that the entrusted production enterprise organizes production in accordance with laws and regulations, mandatory national standards, technical specifications, and technical requirements stated in the registration and filing materials for cosmetics. 

Article 53 The entrusting party shall establish and implement a supervision system for the production activities of the entrusted production enterprise, supervise the production activities of the entrusted production enterprise at all links, and ensure that the entrusted production enterprise produces in accordance with legal requirements.

The entrusting party shall establish and implement a replacement system for the entrusted production enterprise. If it is found that the production conditions and production capacity of the entrusted production enterprise have changed and no longer meet the needs of the entrusted production, the entrustment shall be stopped in time and the entrusted production enterprise shall be replaced according to production needs. 

Article 54 The entrusting party shall establish and implement cosmetics registration and filing management, employee health management, employee training, quality management system self-inspection, and product release management. Quality management systems such as product sample management, product sales records, product storage and transportation management, product return records, product quality complaint management, and product recall management shall be established and implemented, and a cosmetics adverse reaction monitoring and evaluation system shall be established and implemented.

If the entrusting party provides materials to the entrusted production enterprise, the entrusting party shall establish and implement relevant systems such as material supplier selection, material review, material purchase inspection records and acceptance, and material release management in accordance with the requirements of this specification. The entrusting party shall establish and implement other relevant quality management systems in accordance with this specification based on the actual entrusted production. 

Article 55 The entrusting party shall establish and implement a product release management system. On the basis of the entrusted production enterprise completing the release of the product, it shall ensure that the product has passed the inspection and the relevant production and quality activity records have been reviewed and approved before it can be released on the market.

The cosmetics sold on the market shall be accompanied by a product quality inspection certificate in the form of a factory inspection report or a qualified mark. 

Article 56 The entrusting party shall establish and implement a sample retention management system and retain samples at its residence or main business premises; it may also retain samples at other business premises where the base residence or main business premises are located. The retention of samples shall comply with the provisions of Article 18 of this specification. If the sampling location is not the entrusting party’s residence or main business premises, the entrusting party shall report the address and other information of the sampling location to the local department responsible for drug supervision and management within 20 working days from the date of the first sampling.

Article 57 The entrusting party shall establish and implement a record management system and keep records of activities related to this specification. The records shall comply with the relevant requirements of Article 13 of this specification. If the relevant records of the implementation of the production quality management specification are kept by the entrusted production enterprise, the entrusting party shall supervise its preservation of relevant records.

Chapter 8 Product Sales Management

Article 58 Cosmetics registrants, record holders, and entrusted production enterprises shall establish and implement a product sales record system and ensure that the shipping documents and sales records of the products sold are consistent with the actual goods.

Product sales records shall at least include product name, special cosmetics registration certificate number or general cosmetics filing number, expiration date, net content, quantity, sales date, price, and the name, address and contact information of the purchaser.

Article 59 Cosmetics registrants, record holders, and entrusted production enterprises shall establish and implement a product storage and transportation management system. Store and transport products in accordance with the provisions of relevant laws and regulations and the requirements of product labeling, regularly inspect and promptly handle products with abnormal quality such as deterioration or exceeding the expiration date.

Article 60 Cosmetics registrants, record holders, and entrusted production enterprises shall establish and implement a return record system. The content of the return record shall include the return unit, product name, net content, expiration date, quantity, reason for return and handling results. 

Article 61 Cosmetics registrants, record holders and entrusted production enterprises shall establish and implement a product quality complaint management system, designate personnel to handle product quality complaints and record them. The quality management department shall analyze and evaluate the content of the complaint and improve product quality. 

Article 62 Cosmetics registrants and record holders shall establish and implement a cosmetics adverse reaction monitoring and evaluation system. Entrusted production enterprises shall establish and implement a cosmetics adverse reaction monitoring system.

Cosmetics registrants, record holders and entrusted production enterprises shall be equipped with institutions and personnel corresponding to the types and quantities of cosmetics they produce, carry out adverse reaction monitoring work in accordance with regulations and form monitoring records.

Article 63 Cosmetics registrants and record holders shall establish and implement a product recall management system and implement recall work in accordance with the law. If a product is found to have quality defects or other problems,. It may endanger human health, it shall immediately stop production, recall products that have been put on the market, notify relevant cosmetics operators and consumers to stop operating and using, and record the recall and notification. Recalled products shall be clearly marked and stored separately, and remedial, harmless treatment, destruction and other measures shall be taken as appropriate. The recall and handling of cosmetics due to product quality issues shall be reported to the drug supervision and administration department of the province, autonomous region or municipality where they are located in a timely manner by the cosmetics registrant and recorder. The entrusted production enterprise shall establish and implement a product cooperation recall system. If it is found that the products it produces are in the circumstances specified in the first paragraph, it shall immediately stop production and notify the relevant cosmetics registrants and recorders. If the cosmetics registrant and recorder implements a recall, the entrusted production enterprise shall cooperate. The content of the recall record shall at least include the product name, net content, expiration date, recall quantity, actual recall quantity, recall reason, recall time, handling results, and report to the regulatory authorities.

Chapter 9 Supplementary Provisions

Article 64 The meanings of the relevant terms in this specification are as follows: Batch: a certain number of cosmetics with uniform quality produced in the same production cycle and the same process Batch number: a unique identifier used to identify a batch of products, which can be a set of numbers or any combination of numbers and letters, used to trace and review the production history of the batch of cosmetics. Semi-finished products: refers to products that have completed all other production and processing processes except filling or filling processes. Materials: raw materials and packaging materials used in production. Semi-finished products purchased from outside should be managed in accordance with materials. Finished products: products that have completed all production processes and are labeled.

Products: semi-finished and finished cosmetics produced.

Process water: water used to manufacture and process products and related to the manufacturing and processing process in production.

Inner packaging: packaging materials that directly contact the contents of cosmetics. Production workshop: the area engaged in the production and storage of cosmetics, which can be divided into clean area, quasi-clean area and general production area according to the product process environment requirements. Clean area: an area (room) where the number of dust particles and microorganisms in the environment needs to be controlled. Its building structure, equipment and use should be able to reduce the introduction, generation and retention of pollutants in the area.

Quasi-clean area: an area (room) where the number of microorganisms in the environment needs to be controlled. Its building structure, equipment and use should be able to reduce the introduction, generation and retention of pollutants in the area. Production area: a production area that does not contact the contents of cosmetics, clean the inner packaging materials, and does not control the number of microorganisms during the production process. Material balance: a comparison between the sum of the actual output or actual usage of products and materials and the collected losses and the theoretical output or theoretical usage, and consider the allowable deviation range.

Requirements for electronic records in cosmetic production

If a computer (electronic) system (hereinafter referred to as the "system") is used to generate and save records or data, corresponding management measures and technical means shall be taken, and operating procedures shall be formulated to ensure that the generated and saved data or information are true, complete, accurate and traceable. Electronic records shall at least achieve the same functions as the original paper records and meet the requirements of activity management. In the case of coexistence of electronic records and paper records, the form used as a benchmark shall be clearly specified in the operating procedures and management system.

Systems using electronic records shall meet the following functional requirements:

• The system shall be verified to ensure the consistency of the recording time with the system time and the authenticity and accuracy of the data,

• The system shall be able to display all the data in the electronic record, and the generated data shall be readable and printable;-)

• There shall be effective measures to ensure the security of the teaching data. The data generated by the system shall be backed up regularly, and the backup and deletion of the data shall be recorded accordingly. When the system is changed, upgraded or retired, measures shall be taken to ensure that the original system data can be consulted and traced within the prescribed retention period:

• Ensure the uniqueness and traceability of the logged-in user. Specify the user login permissions to ensure that only personnel with login, modification and editing permissions can log in and operate. When electronic signatures are used, they shall comply with the relevant regulations of the "Electronic Signature Law of the People's Republic of China";

• The system shall establish an effective automatic tracking system that can track and query login, modification, copying, printing and other behaviors:

• Relevant information on system operations shall be recorded, including at least the operator, operation time, operation process, operation reason, data generation, modification, deletion, reprocessing, renaming, transfer, changes or modifications to system settings, configuration, parameters and timestamps, etc.