In-depth analysis of key points of entrusted production management in "Cosmetics Production Quality Management Standard"

The "Cosmetics Production Quality Management Specification" (hereinafter referred to as the "Specification") will be implemented on July 1 this ye.

Specify the qualifications of both parties

The legal qualifications of both the entrusting parties are the premise for carrying out the entrusted production activiti.

For the entrusting party, Article 48 of the "Specifications" stipulates that if the production of cosmetics is entrusted, the entrusting party shall be the registrant or recorder of the produced cosmeti.

For the entrusted production enterprises, Article 48 of the "Specifications" stipulates that the entrusted production enterprises should be enterprises with valid cosmetics production licenses, and accept the entrustment within the scope of their production licens.

It should be noted that after some entrusted manufacturing enterprises accept the entrustment of the registrant or filer to produce cosmetics, when the production demand increases sharply in a specific period or the production conditions of the enterprise change, they may transfer the order to other manufacturing enterprises without authorizati.

Clarify the responsibilities of the quality and safety person in charge of the entrusting party

In the operation of the quality management system of the entrusting party, the person in charge of quality and safety plays an important ro.

There are seven responsibilities of the quality and safety person in charge of the entrusting party in the Specificati.

For the entrusting party, the establishment of the registration and filing management system is to ensure that the products are registered and filed in accordance with the law, and the quality and safety person in charge of reviewing the product registration and filing materials is to confirm the product quality and safety, and to clarify production-related quality requirements to the entrusted manufacturer to ensure delive.

The entrusting party shall clarify the responsibilities and authorities of the person in charge of quality and safety, and establish relevant systems to ensure that the person in charge of quality and safety can independently perform the corresponding duti.

Strengthen the supervision of the production activities of the entrusted production enterprises

Both the "Regulations" and the "Measures" stipulate that the entrusting party shall supervise the production activities of the entrusted production enterprises, and set legal liabilities for corresponding illegal ac.

Article 53 of the "Specifications" states that the entrusting party shall establish and implement the supervision system for the production activities of the entrusted production enterprises, but there are no restrictions on how to carry out supervision and what specific supervision measures should be tak.

Special attention should be paid to the supervision of the entrusted production enterpris.

Implement the product double release system

Cosmetics commissioned production implements a double release syst.

According to the "Specifications", the entrusting parties need to carry out two identical tasks: ensuring product inspection is qualified, and reviewing and approving relevant recor.

Request both parties to retain samples

Cosmetics commissioned production implements the double-reservation syst.

The entrusted production enterprise shall implement the retention of samples in accordance with the provisions of Article 18 of the "Specifications"; the requirements of the entrusting party in terms of the quantity of retained samples, the packaging form of retained samples, the storage conditions of retained samples, the storage period of retained samples, the observation of retained samples, and the records of retained samples are consistent with the requirements of the entrusting par.

In terms of the number of retained samples, the entrusting party can refer to the "Reference Table for the Quantity of Cosmetic Registrants and Filers' Product Retention Samples" in the State Food and Drug Administration's "Cosmetics Supervision and Administration Frequently Asked Questions (3)" to determine; for unlisted product types, Determine the number of reserved samples according to the requirements of regulations; for cosmetics products with a net content of less than 1 gram, the samples can be reserved by adding finished products and semi-finished produc.

It should be noted that the reserved samples should meet the requirements of product quality inspecti.

The entrusting party should regularly observe the samples according to the reserved sample syst.

If the samples are found to have deteriorated within the use period, they should analyze the reasons in a timely manner and recall the batches that have been marketed according to l.

Cosmetics, proactively eliminate safety ris.

Source/China Pharmaceutical News

Text / Shanghai Food and Drug Administration Jin Xin