Requirements, duties, and possibility of holding multiple positions for the three roles of responsible persons in the cosmetics manufacturing and sales industry

Updated: July 2025, 8

　Cosmetics manufacturing and sales industry's three top executives (pharmaceutical affairs three top executives)

To obtain permission to manufacture and sell cosmetics, three responsible persons must be appointed.
These are called the "three pharmaceutical roles"General manufacturing and sales manager,Quality Assurance Manager,Safety management managerRefers to that.
　
General manufacturing and sales managerhas overall responsibility for the quality and safety of our products.
Requirements include a pharmacist qualification, completion of a specialized course in chemistry or pharmacy, and experience in related work.
　
Quality Assurance Managerhas established a management system to maintain product quality and also handles defective products.
This position does not require a position in the sales department and requires appropriate knowledge and experience.
　
Safety management managerwill collect safety information and implement necessary measures.
This is also independent from the sales department and requires expertise.
　

From here, we will explain in more detail the requirements for these positions, the job content, and whether they can be held concurrently.

　General manufacturing and sales manager

Cosmetics manufacturers and distributors are required to appoint a general manufacturing and sales manager as the person responsible for overseeing the quality assurance and safety management of cosmetics.
A person who falls under any of Article 85, Paragraph 2 of the Enforcement Regulations of the Pharmaceutical and Medical Device Act may serve as the general marketing manager.

Requirements for general manufacturing and sales manager

①Pharmacist

Applies to those who hold pharmacist qualifications.
Since full-time employment is required at a manufacturing and sales license, a person who is currently working at another pharmacy cannot be appointed as the general manufacturing and sales manager.

② Those who have completed a specialized course related to pharmacy or chemistry at a junior high school or high school under the old system, or a school of equivalent or higher level.

Those who have earned a certain number of credits in pharmacy or chemistry at a high school, vocational school, university, etc. fall under this requirement.
Although the number of credits etc. differs depending on the local government, in general, students are required to have completed 10 to 20 credits of courses related to pharmacy or chemistry as specialized courses at university.

③ After completing a specialized subject related to pharmacy or chemistry at a junior high school or high school under the old system, or a school of equivalent or higher level, engage in work related to quality control or post-marketing safety control of pharmaceuticals, quasi-drugs, or cosmetics for three years or more. person who did

Those who have acquired a certain level of credits in pharmacy or chemistry at a high school, vocational school, university, etc., and who are working as a licensee for manufacturing and sales of pharmaceuticals, quasi-drugs, and cosmetics related to quality control or post-marketing safety management. Those who have 3 years or more of work experience fall under this requirement.
Experience at a company licensed to manufacture and sell pharmaceuticals, quasi-drugs, and cosmetics is required; experience at a manufacturer does not meet this requirement.
The number of credits etc. differs depending on the local government, but generally speaking, if you have taken chemistry as a regular high school subject, you can be selected as long as you meet the qualifications for work experience.

General manufacturing and sales manager concurrently serves as quality assurance manager and safety management manager

General manufacturing and sales managers, quality assurance managers, and safety management managers may work in the same location and to the extent that it is reasonable for them to hold concurrent positions, such as not interfering with their respective duties. , it will be possible for three parties to hold concurrent positions.

　Quality Assurance Manager

Cosmetics manufacturers and distributors are required to appoint a quality assurance manager to be responsible for quality control operations for cosmetics.
Based on Article 17 of the GQP Ministerial Ordinance, a person who meets the following requirements may be appointed as the Quality Assurance Manager.

Requirements for Quality Assurance Manager

① Must have the ability to carry out quality control operations appropriately and smoothly.

No qualifications or experience are required, but quality control work carries the important responsibility of distributing cosmetics on the market.
In addition, this person will be responsible for a large amount of work in daily operations.
Appropriate personnel selection within the company is required.

② The applicant must not be a member of a department related to the sale of pharmaceuticals, etc. or medical devices, or otherwise pose a risk of interfering with the appropriate and smooth performance of quality control operations.

Pharmaceuticals, etc. refer to pharmaceuticals, quasi-drugs, cosmetics, and regenerative medicine products.
Persons belonging to sales departments such as sales departments cannot be appointed as quality assurance managers.

Duties of quality assurance manager

The duties that the quality assurance manager is responsible for are as follows.

• Market Delivery Management
• Ensuring proper manufacturing and quality control
• Information regarding quality, etc. and handling of quality defects, etc.
• Collection process
• Document and record management

Quality assurance manager concurrently serves as general manufacturing and sales manager/safety management manager

General manufacturing and sales managers, quality assurance managers, and safety management managers may work in the same location and to the extent that it is reasonable for them to hold concurrent positions, such as not interfering with their respective duties. , it will be possible for three parties to hold concurrent positions.

　Safety management manager

Retailers are required to appoint a safety manager to be responsible for cosmetic safety management operations.
The Safety Management Officer can be appointed by a person who meets the following requirements based on Article 13, which applies mutatis mutandis to Article 15 of the GVP Ministerial Ordinance.

Safety management officer requirements

① Persons who have the ability to appropriately and smoothly carry out safety assurance tasks.

Although no qualifications or work experience are required, safety assurance duties are an important responsibility for distributing cosmetics to the market.
Appropriate personnel selection within the company is required.

② The applicant must not belong to a department related to the sale of pharmaceuticals, etc., and there is no other risk of interfering with the proper and smooth performance of safety assurance operations.

Pharmaceuticals, etc. refer to pharmaceuticals, quasi-drugs, cosmetics, and regenerative medicine products.
Persons belonging to sales departments such as sales departments cannot be appointed as safety management managers.

Safety management officer duties

The duties that the safety management manager is responsible for are as follows.

• Collection of safety management information
• Reviewing safety management information and proposing safety measures based on the results
• Implementation of safety measures

Safety management manager concurrently serves as general manufacturing and sales manager/quality assurance manager

General manufacturing and sales managers, quality assurance managers, and safety management managers may work in the same location and to the extent that it is reasonable for them to hold concurrent positions, such as not interfering with their respective duties. , it will be possible for three parties to hold concurrent positions.

　For consultation regarding cosmetics-related permits, please contact Support Administrative Scrivener Corporation.

At the Support Administrative Scrivener Corporation, we provide procedural support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the cosmetics industry to existing marketing agents, 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 has a track record of applying in all prefectures across the country. Please contact us by all means.