Recently, the Guangzhou Administration for Market Regulation released the "Questions and Answers on Filling of Ordinary Cosmetics" (Issue 60) and (Issue 61).

Guangzhou Administration for Market Regulation--FAQs on Filling of Ordinary Cosmetics (60th Issue)

1、Q: What obligations should the entrusting party bear for the production of cosmetics?

A: For the production of cosmetics, the entrusting party shall be the registrant or recorder of the produced cosmetics. It shall establish a corresponding quality management system and organizational structure, be responsible for the quality, safety and efficacy claims of the cosmetics throughout the life cycle, perform registration and filing management, production activity supervision, as well as post-market adverse reaction monitoring, evaluation and reporting, product risk control and recall, product and raw material safety re-evaluation and other related obligations.

2、Q: What quality management systems should the entrusting party establish?

A: The quality management systems that the entrusting party should establish and implement include but are not limited to the following:

Cosmetics registration and filing management, employee health management, employee training, quality management system self-inspection, product release management, product sample management, product sales records, product storage and transportation management, product return records, product quality complaint management, product recall management, and cosmetics adverse reaction monitoring and evaluation system. If the entrusting party provides materials to the entrusted production enterprise, the entrusting party shall also establish and implement relevant systems such as material supplier selection, material review, material purchase inspection record and acceptance, and material release management in accordance with the requirements of the "Cosmetics Production Quality Management Standards".

3、Q: How should the entrusting party implement the sample retention management system?

A: The entrusting party shall retain samples on its own and shall not entrust the production enterprise to retain samples on its behalf. The entrusting party shall retain samples at its residence or main business premises, or at other business premises where its residence or main business premises are located (usually deemed to be within the administrative area of the same prefecture-level city or municipality directly under the Central Government). If the sampling location is not its 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.

Samples shall be retained for each batch of products shipped out of the factory, and the number of samples retained shall be at least twice the amount required for factory inspection, and shall meet the requirements of product quality inspection. The retention period of the retained samples shall not be less than 6 months after the expiration of the product's shelf life. Keep good records of sample retention. If it is found that the sampled product has deteriorated during the shelf life, the enterprise shall promptly analyze the cause and recall the batch of cosmetics that have been marketed in accordance with the law to actively eliminate safety risks.

4、Q: How should the entrusting party supervise the production activities of the entrusted party?

A: The entrusting party shall establish a system for supervising and managing the production activities of the entrusted production enterprise, and clarify the content, method, frequency, and handling methods of problems found in the supervision and management. The entrusting party shall take effective supervision measures according to the company's own situation. In actual operation, various measures such as dispatching quality management personnel to the entrusted production enterprise, irregular on-site inspections, or regular sample inspections can be taken to ensure that the entrusted production enterprise produces in accordance with laws and regulations, technical requirements stated in the registration and filing materials, and quality requirements of the entrustment agreement, and form supervision records.

5、Q: How should the entrusting party select qualified entrusted production enterprises?

A: The entrusting party shall establish the selection criteria for entrusted production enterprises, and determine the selection criteria for entrusted production enterprises according to the type, unit, production scale, production frequency, quality requirements, etc. of the entrusted products. Before the first entrusted production, the production enterprise shall be subject to qualification review and inspection and evaluation.

The focus of the qualification review is whether the entrusted production enterprise has the basic conditions for entrusted production. The main review is whether the enterprise has a valid production license; whether it has production license items that are consistent with the intended entrusted products; for children's skin care and eye skin care cosmetics, it is also necessary to see whether it has the corresponding production conditions.

The inspection and evaluation focus on the production capacity of the entrusted production enterprise and the establishment and operation of the production quality management system. The inspection and evaluation is generally carried out in the form of on-site assessment of the production enterprise. The assessment content mainly includes the production environment, production and inspection facilities and equipment, management and technical personnel, material and product management, quality management and quality control, quality management system and record system of the production enterprise. During the inspection, you can refer to the records of the company's previous inspections by regulatory authorities or third-party quality system certification.

Guangzhou Administration for Market Regulation--FAQs on Filling of Ordinary Cosmetics (61st Issue)

1、Q: What are the statutory responsibilities of the person in charge of quality and safety?

A: The person in charge of quality and safety appointed by the registrant/registrant of the entrusted production of cosmetics shall assist the legal representative of the enterprise in assuming the following corresponding product quality and safety management and product release responsibilities:

(i) 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;

(ii) Decision-making on product quality and safety issues and issuance of relevant documents;

(iii) Review of cosmetic registration and filing materials;

(iv) Review and management of material suppliers and material release for materials purchased and provided by the entrusting party;

(v) Product release for marketing;

(vi) Supervision and management of the selection of entrusted production enterprises and production activities;

(vii) Monitoring and management of adverse reactions to cosmetics.

2、Q: What abilities should the person in charge of quality and safety have to perform his duties?

Answer: (i) Ability to apply professional knowledge. Possess professional knowledge related to cosmetics quality and safety that meets the requirements of job responsibilities and can apply it in quality and safety management;

(ii) Ability to apply legal knowledge. Be familiar with laws and regulations related to cosmetics and be able to ensure that the company's quality and safety management work complies with the provisions of laws and regulations;

(iii) Organization and coordination ability. Possess the leadership ability to organize and implement the company's cosmetics quality and safety responsibility system and be able to effectively organize and coordinate the work of the company's quality and safety-related departments;

(iv) Risk assessment ability. Be familiar with cosmetics quality and safety risk management work and be able to accurately identify and judge product quality risks that may arise in the company's production and operation activities, and propose solutions;

(v) Other cosmetics quality and safety management abilities that should be possessed.

3、Q: What are the qualifications for the person in charge of quality and safety?

A: (i) Professional knowledge requirements: Must have professional knowledge related to cosmetics quality and safety, such as cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health or law. Professional knowledge can be reflected in academic education, non-academic education, technical titles or effective training.

(ii) Work experience requirements: Familiar with relevant laws and regulations, mandatory national standards, technical specifications, and have more than 5 years of experience in cosmetics production or quality management. In regulatory practice, the person in charge of cosmetics quality and safety, on the premise of having professional knowledge related to cosmetics quality and safety, can be regarded as having experience in cosmetics production or quality and safety management in the production or quality management of drugs, medical devices, and special foods.

4、Q: Can the person in charge of quality and safety hold other positions concurrently?

A: (i) Requirements for part-time work across enterprises: In order to ensure effective performance of duties, the person in charge of quality and safety is generally not allowed to hold part-time work across enterprises. When the cosmetics registrant/registrant and the entrusted production enterprise belong to the same group company and implement the same quality management system, and the entrusted production enterprise accepts the commissioned production of the registrant/registrant, the registrant/registrant and the entrusted production enterprise can employ the same natural person as the person in charge of quality and safety.

(ii) Requirements for part-time work within the enterprise: The person in charge of quality and safety should be able to perform his duties independently without interference from other personnel of the enterprise. He shall not hold concurrent positions as the head of a department that affects his independent performance of duties, such as the head of the production department. For smaller enterprises, the person in charge of quality and safety can concurrently hold the head of the quality management department.

5、Q: How to ensure that the person in charge of quality and safety performs his duties independently and is not interfered with by others?

A: First, the quality system documents of the enterprise clearly stipulate that the person in charge of quality and safety should perform his duties independently and not be interfered with by other personnel, especially the main person in charge of the enterprise or other managers at the same level, and stipulate the responsibilities and penalties that should be borne if other people arbitrarily interfere with the correct decision-making of the person in charge of quality and safety.

Second, the legal representative of the enterprise should also fully listen to the opinions of the person in charge of quality and safety before making quality and safety decisions.

Third, the person in charge of quality and safety should perform his duties correctly, and when interfered with, he should stick to his position and bear in mind his legal responsibilities.

Of course, the person in charge of quality and safety should also continuously improve his ability to perform his duties, and should pay attention to listening to well-intentioned suggestions, especially those that are beneficial and positive to ensuring product quality and safety.