What is cosmetics manufacturing and sales industry?
Cosmetic manufacturing and sales business is a license required to ship and distribute cosmetics within Japan. In other words, it can be said to be the "final person responsible for the cosmetics shipped and distributed to the world (market)."
Cosmetics are originally supposed to have a mild effect on the human body, but when applied to people's skin, they can cause various health hazards such as skin irritation, eczema, and itchiness that will not subside. may lead to.
Cosmetics manufacturers and distributors are the ``ultimate holders of the market'' for such potentially dangerous cosmetics.
Also applicable when handling separate production and sales or imported cosmetics
We bear an important responsibility for ensuring the appropriate quality of cosmetics, not only when we manufacture cosmetics in-house, but also when we outsource production to other companies (so-called "separation of production and sales"), or when we import finished cosmetics from overseas.
The Pharmaceutical Affairs Law stipulates various roles for cosmetics manufacturers and distributors to ensure the appropriate quality of the cosmetics they handle, always ensure their safety, and prevent health hazards.
When obtaining permission for cosmetics manufacturing and sales business, such <Is it suitable as a “company or individual” with important responsibilities?From this perspective, the organizational structure, division of duties, status of establishment of manuals (GVP/GQP, etc.), knowledge and experience of the person in charge, etc. will be examined. Therefore, applications must be made for each "company or individual" (cf: Cosmetics manufacturing industryIn this case, application will be made for each "location."
Differences between the cosmetics manufacturing and sales industry and the cosmetics manufacturing industry
There are two types of cosmetics licenses: "Cosmetics Manufacturing and Sales License" and "Cosmetics Manufacturing License". These permits must be obtained depending on the nature of the work and the scope of responsibilities.
A cosmetics manufacturing and sales license is a license required to ship and sell your own brand of cosmetics to the market. Manufacturers bear the ultimate responsibility for the quality and safety of their products, and are obligated to control the quality of products shipped to the market, as well as collect, analyze, and evaluate safety information, and take appropriate measures as necessary.
On the other hand, a cosmetics manufacturing license is not required to manufacture cosmetics. Depending on the manufacturing process, they are further classified into two categories: "general category" and "packaging category."
The role of cosmetics manufacturers and distributors
The main roles of a cosmetics manufacturer and distributor are as follows.
Quality control and post-marketing safety management
Properly manage the quality and post-sales safety of the products you intend to manufacture and sell.
Appoint a general manufacturing and sales manager, quality assurance manager, and safety manager who meet certain requirements
To give the necessary consideration to the Chief Manufacturing and Sales Manager in order to fulfill his/her legal responsibilities, and to respect his/her opinions.
Ensure that the general manufacturing and sales manager properly supervises the quality assurance manager and safety management manager
The general manufacturing and sales manager, quality assurance manager, and safety manager must cooperate with each other and take necessary measures to ensure that they can carry out their duties.
Establish and prepare various documents stipulated by the Pharmaceutical Affairs Law and procedures related to GVP and GQP
Ensure that employees involved in the quality control of cosmetics perform their duties properly and smoothly in accordance with the above procedure manual.
Records created based on the above procedures must be properly stored.
Providing information to consumers
Establish a system that can provide accurate information in response to consumer inquiries.
Reporting of side effects, etc.
When you become aware of a research report or other information indicating that a cosmetic product you have manufactured or sold may have harmful effects,Within 30 days from the day of enrollmentto report the matter to the Minister of Health, Labor and Welfare.
Reporting a recall
When a voluntary recall of a manufactured or sold cosmetic product is initiated, the company must promptly report the statutory details to the governor of the prefecture having jurisdiction.
How to manufacture and sell cosmetics?
Cosmetic manufacturing and sales industry requirements
To manufacture and sell cosmetics, the following requirements must be met:
① Preparation of procedure manuals (GQP, GVP)
② Establishment of <General Manufacturing and Sales Manager> <Quality Assurance Manager> <Safety Management Manager>
③The applicant (in the case of a corporation, the officer conducting the business) does not fall under any of the reasons for disqualification.
Check it out in the video!
① Preparation of procedure manuals (GQP, GVP)
What is the GQP Ministerial Ordinance (Good Quality Practice)?A ministerial ordinance that stipulates standards such as systems and rules necessary to maintain appropriate quality control of cosmetics..
What is the GVP Ministerial Ordinance (Good Vigilance Practice)?A ministerial ordinance that stipulates standards such as systems and rules necessary to ensure the safety management of cosmetics after they are manufactured and sold..
In order to obtain a manufacturing and sales license for cosmetics, compliance with this GQP Ministerial Ordinance and GVP Ministerial Ordinance is a requirement, and it is necessary to establish a manual to properly operate business in accordance with this Ministerial Ordinance.
This manual is called a "procedure manual", and when applying for a cosmetics manufacturing and sales license, the details of the procedure manual, the status of its establishment, and the response status are examined during an on-site inspection by the Pharmaceutical Affairs Division. It will take shape.
② Establishment of <General Manufacturing and Sales Manager> <Quality Assurance Manager> <Safety Management Manager>
These responsible persons are the key persons in carrying out the work specified in the procedure manual in ①, and are often referred to as the "three roles (three responsibilities)."
These three roles, with the ``General Manufacturing and Sales Manager'' at the top, ensure proper business operations in a triangular structure as shown below.
For the three roles, it is preferable to have one person in charge of each role, but it is possible for the person to serve concurrently.
However, even if they hold concurrent positions, each person in charge must fulfill their respective roles.
The "General Manufacturing and Sales Manager" must meet one of the following requirements.
Additionally, the general manufacturing and sales manager must be full-time.
Requirements
certificate
1
pharmacist
Pharmacist license (Original trade name is required at the Pharmaceutical Affairs Division counter)
2
Those who have completed a specialized course related to pharmacy or chemistry at a high school or equivalent or higher school.
Example) Graduation certificate or diploma
Credit acquisition certificate (Required depending on major)
3
A person who has completed a subject related to pharmacy or chemistry at a high school or equivalent or higher school and has been engaged in work related to quality control or post-marketing safety control of pharmaceuticals, quasi-drugs, or cosmetics for three years or more.
Example: Certificate of credit acquisition Certificate of employment
Reference: [Cosmetics Permit] Procedures required for manufacturing and sales businesses
About the three roles of responsible persons in the cosmetics manufacturing and sales industry
For more information about the three roles of managers in the cosmetics manufacturing and sales industry, please see the following page.
GQP is an agreement that stipulates what is necessary to ensure product quality correctly and smoothly.
GQP is required to ensure comprehensive quality. In addition to checking factory management, you will be responsible for overall quality after shipment to the market. As standards for quality control, there is the Ministerial Ordinance on Quality Control Standards for Pharmaceuticals, Quasi-drugs, Cosmetics, and Medical Devices (hereinafter referred to as the "GQP Ministerial Ordinance").
Complying with the GQP Ministerial Ordinance For quality control of cosmetics, it is necessary to comply with the GQP Ministerial Ordinance. The GQP Ministerial Ordinance is a condition for obtaining a manufacturing and sales license, and compliance with the GQP Ministerial Ordinance is also a condition for maintaining the license.
The GQP Ministerial Ordinance requires cosmetics manufacturers and distributors to: This is a mandatory item and does not prevent other items (self-inspection, education and training, etc.) from being implemented.
1: Have sufficient personnel who have the ability to carry out quality control operations properly and smoothly.
As a manufacturer and distributor, you must determine that a person has the ability to do so by comparing the work content, practical experience, education and training, etc.
2: Have the general manufacturing and sales manager do the following:
Supervision of Quality Assurance Manager and Quality Assurance Managerrespect for opinions.
In response to reports from quality assurance managers such as quality information, etc.Decide on necessary measuresand instruct the quality assurance manager to implement the same.
Communication between the quality assurance manager, safety management manager, and other related personnelEncourage close cooperation.
3: Appointment of a quality assurance manager
We perform quality control work after comprehensively evaluating work history, years of experience, education and training status, educational background, etc.A person who can be entrusted with responsibilityAnd cosmeticsPersons who do not belong to departments related to salesA person who is not likely to interfere with the proper and smooth execution of quality control operations shall be appointed as the quality assurance officer.
4: Have the quality assurance manager do the following:
Oversees quality control operations.
Confirm that quality control operations are being carried out properly and smoothly.
When necessary for the performance of quality control operations, reports shall be made in writing to the general marketing and sales manager.
When performing quality control operations, communicate or provide instructions in writing to manufacturers and other related parties as necessary.
5: Creating quality control procedures
In order to carry out quality control work properly and smoothly, documents related to the following procedures (hereinafter referred to as "quality control work procedure manual") must be created.
In addition, the created quality control work procedure manual will be kept in the office where the general manufacturing and sales manager conducts his work, and copies of the necessary parts of the quality control work procedure manual will be sent to other offices that perform quality control work. To be equipped.
1
Procedures for creating records related to market shipments
2
Procedures for ensuring proper manufacturing control and quality control
3
Information regarding quality, etc. and procedures for handling quality defects, etc.
4
Procedures for collection processing
5
Procedures for document and record management
6
Procedures related to other necessary quality control operations Procedures for self-inspection, procedures for education and training, procedures for mutual cooperation with safety management personnel, For manufacturers and distributors to conduct quality control operations, such as creating quality standard documents and making arrangements with manufacturers, Prepare necessary matters.
6: Implementation of quality control operations
In order to ensure product quality, perform the following operations based on the quality control work procedure manual.
① Creation of records regarding shipment to the market
1
Appropriately evaluate the results of manufacturing control and quality control, and decide whether or not each lot can be shipped to the market. The following items may be considered during evaluation: A. Confirmation of manufacturing records (confirmation that products are manufactured according to quality standards) B. Confirmation of test and inspection records (confirmation that the specifications of the quality standard document are met) C. Others (confirmation of changes in raw materials, manufacturing method, etc., storage status, etc.)
2
Create records regarding the results of 1. whether or not the product can be shipped and the destination of the shipment. Lot information should also be provided so that recall and other measures can be implemented promptly. The following records can be considered as records to be created. A Records related to evaluation of manufacturing control and quality control results B. Records related to decisions regarding whether or not to ship to the market (state the sales name, lot number, decision maker, decision date, etc.) C. Accounting and disbursing records (listing sales name, lot number, quantity of disbursements, shipping destination, etc.)
② Confirmation and record creation of proper and smooth manufacturing
Confirm that the product has been manufactured properly and smoothly by the manufacturer, etc. through on-site inspections based on the agreement, and create a record of this.
③Processing quality information and creating records
When information (including complaints) about quality, etc. is obtained, an evaluation will be conducted regarding the impact of the matter related to the information on human health, an investigation will be conducted into the cause, and if improvements are required, the necessary measures will be taken. Also, create records of these.
④ Written communication to the safety manager
Among quality information, information regarding safety measures shall be provided in writing to the safety management manager without delay.
⑤Measures such as collection and record creation
If a quality defect or suspected quality defect is discovered, necessary measures such as recall will be implemented immediately and a record will be kept. If there is no mention of the lot in the "Shipping Records," the record applies to all lots that may have been distributed in the market, without any lot restrictions.
7: Document and record management
Documents and records relating to quality control shall be valid from the date of creation (or from the date of discontinuance of use for quality control work procedures).5 yearsTo save.
When a document is created or revised, the document must be approved, distributed, stored, etc.
The quality control procedure manual includes the following:Creatoras well as the Creation date,andPerson responsible for revision,Revision date,Revisionsas well as the Reason for revisionIn addition, the revision history should be saved.
What is GVP? GVP requirements
GvpIsAgreements stipulating matters related to "product safety". We collect and consider information such as ``Is this a harmful effect?'' and then decide on the rules for how to respond.
In the case of cosmetics, the frequency of serious side effects and adverse effects is thought to be relatively low, but it is by no means zero. Adverse effects such as ``skin irritation'' and ``feeling itchy'' may occur. Additionally, harmful effects of ingredients may be published in specialized journals or research papers.
In case of an emergency, it is necessary to decide on a response in advance to minimize damage caused by adverse effects.
The standards for post-marketing safety management include the Ministerial Ordinance on Standards for Post-marketing Safety Management of Pharmaceuticals, Quasi-drugs, Cosmetics, and Medical Devices (hereinafter referred to as the "GVP Ministerial Ordinance").
Post-marketing safety management of cosmetics must comply with GVP ministerial ordinances. The GVP Ministerial Ordinance is a condition for obtaining a manufacturing and sales license, and compliance with the GVP Ministerial Ordinance is also a condition for maintaining the license.
The GVP Ministerial Ordinance requires cosmetics manufacturers and distributors to: These are mandatory items and do not preclude the implementation of other items (self-inspection, education and training, etc.).
(Cosmetics manufacturers and distributors fall under the category of "Third Type Marketing Authorizer" under the GVP Ministerial Ordinance.)
GVP Ministerial Ordinance Articles 7 to 9 (applied mutatis mutandis pursuant to Article 15)
6
Document and record management
GVP Ministerial Ordinance Article 16
1: Having sufficient personnel with the ability to properly and smoothly carry out safety assurance operations.
To have sufficient personnel with the ability to properly and smoothly carry out safety assurance operations.
2: Have the general manufacturing and sales manager do the following:
Safety Managerdirected byand Safety Management Officerrespect for opinions - Coordination between the safety management manager, quality assurance manager, and other persons responsible for manufacturing and sales of cosmetics.Encourage close cooperation
3: Appointment of a safety manager
A person who has the ability to properly and smoothly carry out safety assurance duties, and who is a cosmetics manufacturer.Persons who do not belong to departments related to sales- Appoint as the safety manager a person who is not likely to impede the proper and smooth execution of safety assurance operations.
4: Have the safety manager do the following:
Safety assurance workSupervisionTo
Safety assurance workAppropriate and smoothconfirm what is being done, create and save a record of it
When necessary for the performance of safety assurance operations,Report in writing to the general manufacturing and sales managerand save a copy.
5: Implementation of safety management operations
To ensure product safety, perform the following tasks:
①Collecting safety management information
The safety management officer shall collect the following safety management information, create and preserve its records.
A. Information regarding academic conference reports, literature reports, and other research reports.
B Other safety management information
② Examination of safety management information
The safety management manager shall review the collected safety management information without delay and record the results. Additionally, if it is deemed necessary for the quality assurance manager to understand the safety management information, the safety management information shall be provided to the quality assurance manager in writing without delay.
③Planning safety measures
As a result of examining the safety management information, the safety management manager may, if deemed necessary, dispose of, recall, suspend sales, revise package inserts, provide information, or report to the Minister of Health, Labor and Welfare based on the law (reports on side effects, etc.) (recall report, etc.) and other safety measures and report the proposal in writing to the general marketing and sales manager. Also, save a copy.
number
Contents of safety measures
1
The general manufacturing and sales manager shall perform the following duties.
- Properly evaluate proposed safety measures, decide on the safety measures, and prepare and retain records of them. Matters stipulated in advance in documents may be carried out by the safety officer in place of the general marketing and sales manager. However, in this case, it is necessary to define in advance in writing the necessary matters regarding the implementation of security measures.
- When having the safety manager implement safety measures, instruct him/her on their implementation in writing and have him/her keep the written records.
・If a person other than the safety management supervisor is to carry out safety measures, the safety management supervisor shall instruct the implementation in writing and have the safety management supervisor retain a copy of the instructions.
・If a person other than the Safety Management Officer is to take safety measures, have that person create a record of the implementation and report it in writing to the General Marketing and Marketing Manager, and also send a copy to the Safety Management Officer. Have it issued.
2
The Safety Management Officer shall perform the following duties.
・Take safety measures based on the instructions of the general manufacturing and sales manager, and create and preserve records.
・The results of the implementation of safety measures shall be reported in writing to the general marketing and marketing manager, and a copy thereof shall be retained.
6: Document and record management
Documents and records related to safety management operations that are required to be preserved according to the GVP Ministerial Ordinance shall be retained from the day the records, etc. are no longer used.5 yearsTo save. However, for records related to biological products, from the day they are no longer used.10 years, from the date on which records related to specified biological products are no longer used.30 yearsTo save.
For consultation regarding cosmetics-related permits, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act for everyone, from those newly entering the cosmetics industry to existing marketing distributors, manufacturers, and distributors.
Applications for cosmetics are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
Our staff have experience filing applications and notifications in prefectures across the country. Please feel free to contact us.
[GQP/GVP] Comprehensive outsourcing of legal management is also possible
Laws regarding cosmetics licensing are frequently updated, and compliance awareness has particularly increased in recent years. If a violation is discovered, there is a risk of product recall or fines in the worst case, so continuous vigilance is essential.
There have been cases where there were no problems at the time of obtaining the permit, but before you know it you are in violation of the law, so we recommend comprehensive risk management by experts.
This content is especially recommended for "business operators who are about to renew their licenses" and "business operators who have lost their predecessor and are not yet able to keep up with training a successor."
