Jia Na

Center for Food and Drug Inspection of NMPA, China

Abstract

Key words

nation；cosmetics；flight inspection；analysis

Cosmetics flight inspection refers to the supervisory inspection on the cosmetics production, management and other procedures uninformed by cosmetics supervision department.[1]Flight inspection is featured by five outstanding aspects such as the confidentiality of the operation, the suddenness of the reception, the flexibility of the spot and the immediacy of the record.In order to strengthen the prevention and control of safety, the State Drug Administration (SDA) organized the flight inspection towards cosmetics production businesses (hereinafter referred to as business).According to the data of the notice on flight inspection in 2018, the situation of the national cosmetics flight inspection is analyzed herein, with an aim to provide reference to businesses which could improve their production and quality management capability, build the corporate responsibility awareness and ensure the quality safety.

Cause of flight inspection

The inspection of cosmetics include two types:flight inspection out of reasons and random flight inspection.The former involve media exposure, supervision and sampling inspection, risk supervision as well as adverse drug reaction monitoring; random flight inspection is aimed at the businesses with normal operation in line with the principle of double randomness.

The key businesses accepting flight inspection include:(1) businesses with production safety risks detected from the supervision and sampling inspection, risk supervision and supervision of adverse reaction; (2) complaint, exposure or other clues which indicate the existence of potential product safety risks; (3) businesses which may have untrue production certificate, product registration (filing) and other materials；(4) businesses with broken record.

Key contents of flight inspection

National cosmetics flight inspection is mainly based on theRegulation on Cosmetics Production Permit(hereinafter referred to as the Regulation) and theInspection Key Outlines on Cosmetics Production Permit[2](hereinafter referred to as Inspection Key Outlines).The 35tharticle in the Inspection Key Outlines identifies the following aspects of the supervision on businesses:(1) whether or not businesses have engaged in production according to the permit items and have legal Cosmetics Production Permit; (2) whether or not the production condition of businesses is in line with the permit items; (3) whether or not businesses have the risk of quality safety；(4) requirements of other laws and regulations on cosmetics.The Inspection Main Outline has stipulated the permit threshold in the form of list which includes 104 “inspection items”.Among them, there are 26 key items, 70 general items and 8 recommended items.

The items found not conforming to the requirements in the inspection are collectively referred to as “defect items”, which are divided into “serious defects” and “general defects”.The results are as follows:(1) if you refuse to inspect or offer the information needed for inspection, hide, destroy or provide false information (including the files of the computer system), you will be directly judged not to pass; (2) over 5 items with serious defects are judged as not passed; (3) over 20 items (including 20 items) with defects are judged as not passed；(4) less than 5 serious defect items and less than 20 defect items are required to be reformed; (5) If there are no defect items, the inspection results are in line with the requirements; For enterprises which are judged as not passed, we will ask them to take administrative measures that suspend production.

To be specific, the flight inspection mainly targets at ten aspects involving the qualification of the subjects, product access, quality management, inspection management, institution personnel, factory and facility, production equipment, material control, production management and product management.

Qualification of the subjects

Key inspection:if businesses have legal Cosmetics Production Permit and produce based on permitted items; if the production workshop of the enterprise is consistent with the permit and if businesses have arbitrarily change the layout of production workshop; if businesses have engaged in production in nonproduction places.

Product access

Key inspection:the registration or record of products; if products’ actual formula is in accordance with the registration or record formula.If the domestic cosmetics for special use produced by businesses are in line with the annexed production formula and craftsmanship by the Registration Permit of Domestic Cosmetics to conduct production; if the filing and archiving materials of domestic non-special purpose cosmetics produced and sold out of the warehouse are complete and standard.

Quality management

Key inspection:whether the quality management system continues to operate effectively, whether it could ensure product quality and safety; if quality management system is complete and applicable; if the product has been produced and if the quality has been secured according to policies and has been recorded; if materials and products have been released and recorded; if unqualified products have been dealt with and recorded based on rules and if unqualified products have been classified and analyzed with improvement measures to be taken; if product tracking management accords with policies; if internal audit has been carried out and recorded in line with regulations.

Examination and management

Key inspection:if the lab meets the business requirement and if relevant policies are perfect and available and if the management of labs is in accordance with the policies; if the examination standards in terms of materials, intermediates and finished products have been set up and if the inspection and record have been conducted on the basis of standards; if product samples have been reserved.

Institutional person

Key inspection:if organizations have been operated in an orderly manner; if staff have performed their duties while meeting the requirements; if the person in charge of quality and quality management department, as well as the production leader have executed their duties according to the requirements; if inspection persons are qualified to take the inspection work；if the health management of relevant workers accords with stipulations; if the training work is in line with the rules and has been recorded.

Factory and facility

Key inspection:if the hardware facility in production factory meet the requirement of production and relevant rules; if logistics, transportation could avoid two-way pollution; if the environmental monitoring in production factory has mapped out plan and monitored and recorded on a regular basis; if production factory has met with cases like any kind of product pollution due to insect pest, facility or pesticide; if storage zone has been established according to rules and regulations.

Production facility

Key inspection:if the production equipment in the production workshop meets the production conditions; if the management of the production equipment and the instruments with measuring requirements conforms to the regulations with record; if the cleaning and sterilization of water system meet the regulations with record; if the management of process water is up to the standards of production quality with regular monitoring and record; if facility cleaning, sterilization and maintenance meet the standards with record.

Material control

Key inspection:if material is used based on rules and if the banned material has been used and if those materials with limited use has been excessively utilized (the monitoring and sampling inspection need to be done if necessary); if material purchase, acceptance, storage and release are in commensurate with regulations with marks or record; if material supplier management is in line with rules with record.

Production management

Key inspection:if production process is in line with rules with record and if the quality management requirement has been made according to production management policy; if production procedure has been established and implemented in an earnest way; if the production record of the same batch of products could be traced back and if various batches of products could been identified effectively.

Product management

Key inspection:if product packaging label identification is in accordance with legal requirements；if product sales is in compliance with rules and could be traced; if product storage conforms to rules; if product quality and complaint management are in line with rules with record; if negative reaction and monitoring management meet the standards with record; if product callback is up to specification with record.

Analysis on flight inspection results

In 2018, the national bureau issued the flight inspection notice of 42 businesses[3]and found out 431 defected projects, with 148 seriously defected ones；12 businesses failed to pass the inspection as a result, and were required to suspend production, accounting for 28.6% of the total businesses.

Analysis of the result of 10 key flight inspection projects

According to the statistics:for top 7 defected projects, the total of them reaches 420, 97.4% of the defected projects, as is shown in Table 1; for top 5 seriously defected projects, the total of them reaches 139, 93.9% of the total, as is shown in Table 2.

According to the above results, it is far from perfect in terms of material control, inspection management, production and facility, production management, factory and facility, quality management as well as institutional personnel for businesses.In light of seriously defected projects, quality management, production and facility, factory and facility as well as institutional personnel are the key area for risk control and are prone to produce mismatched condition.All this indicates to some degree that since January 1, 2016 when businesses began to set up and operate the production and quality management system in accordance with the guideline and inspection key points, some of them wrongly believed that they could be relaxed once they got the administrative permit and put little emphasis on the sustainable and effective operation of production and quality control system.Enterprises should pay attention to how to maintain the continuous and effective operation of production quality management system.

Table 1.Distribution of top 7 defected projects among flight inspection projects

Table 2.Distribution of the top 5 seriously defected projects among flight inspection

Analysis of result of defected flight inspection

Flight inspection generally does not take recommended items as the content of supervision and inspection, so key items and general items are taken as the analysis objects.In 2018, among 431 defected projects found out by national flight inspection, there exist 148 seriously defected projects and 283 generally defected ones.A total of 111 key projects were discovered, accounting for 75.0% of seriously defected projects.The specific distribution and proportion is seen in Table 3.It turns out that there were altogether 132 general projects ranking at the top 10, 46.6% of the generally defected projects.The distribution and proportion is seen in Table 4.

From the statistical result of Table 3 and Table 4, the defected projects are relatively concentrated, indicating that such problems are common and symbolic to the cosmetics industry and businesses should highlight such projects with concentrated issues.Production water is one of the essential raw materials for cosmetics production.Its quality directly affect the product quality of cosmetics.Enterprises, however, do not pay enough attention to the regular monitoring of clean and sterilized water quality of water treatment system, and the corresponding records are lacked.The absence of production records and quality management records is also one of the obvious problems of enterprises at present, which has a bearing on the fact that enterprises do not pay attention to traceability records.The management of washing and disinfection facilities in the changing room of the production workshop should also be in place to avert pollution risks.Enterprises should also put enough emphasis on the storage of materials and corresponding identification information, product sample reservation, production equipment disinfection and records, and other problems.These are also more common in enterprises.

Suggestions for business to do well in production quality management

Based on the analysis of flight inspection results and the root cause of the problems in the enterprise, it is suggested that the enterprise should do a good job in production quality management from the following dimensions.

Table 3.Distribution of top 10 seriously defected ones

Table 4.Distribution of top 10 generally defected cases

Have a clear picture of the present condition and improve the management system

Businesses should identify what the shortages are concerning the papers on quality management system in accordance with law.And they shall understand the rules and regulations and technological standards in terms of cosmetics supervision before revise their own quality management policy papers.Next, enterprises should promptly organize an internal audit to thoroughly check the weaknesses in the production quality management process.The internal audit shall not be a formalism one but shall be earnestly conducted like flight check (external audit) so as to find out the issues and solutions by themselves.

Sustainable improvement to control key risks

Cosmetics production should highlight the risk factors:first, be legal.Enterprises shall be equipped with the cosmetics production qualification and engage in the cosmetics production within the permitted items, and the products made shall comply with the requirements of laws and regulations; second, make sure the production process of cosmetics is standard and the inspection of the produced cosmetics is passed.And the sold products could be traced.The ultimate goal of continuous improvement is to better the economic benefit and product quality.The establishment of quality management system is not static.Instead, the requirements of laws, regulations and the market are constantly changing.The quality management system of enterprises should also be continuously improved.The enterprise is not to establish a perfect quality management system through licensing, but to make continuous progress as a whole.

Standard management and improve management efficiency

Quality management system documents are not for coping with, but really to guide staff how to better perform their duties.Enterprise personnel must “record as they do” because truthfully and timely record is the real reproduction of production quality management ability while falsification will only be self-defeating.Moreover, businesses shall try their best to “keep papers on file in a timely manner”.It is how they could improve their management efficiency.The sustainable filing could elevate the scale of their own production and quality management.