GVP/GQP
Updated: July 2024, 9
Manufacturers and distributors of cosmetics are obligated to appropriately carry out "quality control" and "post-marketing safety control."
That is,Permits are granted only to companies that are capable of carrying out the work.It will be said.
Therefore, if you want a permit, make sure that you have the ability to properly carry out "quality control" and "post-marketing safety control."
This means that you will have to prove it to the Pharmaceutical Affairs Department.
A tool to prove the ability to appropriately perform "quality control" and "post-marketing safety control"
"GVP・GQP".
Procedure manual for “post-marketing safety management”GVP (Good Vigilance Practice)
Procedure manual for “quality control”GQP(Good Quality Practice)
.
The Pharmaceutical Affairs Division will discuss the contents of the procedure manual.
We examine questions such as ``Do you understand quality control, etc.?'' ``Can you really carry out this procedure after approval?''
If it is determined that the permit criteria are met, the permit will be granted.
The content of the procedure manual will be unique to each company.
In addition, the shipping inspection items are different for "in-house manufacturing" and "imported" products.
In this way, GQP and GVP that match the characteristics of each company are the criteria for approval.
table of contents
What is GVP?
GvpIsDocumentation of post-marketing safety control procedures.
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 quasi-drugs, 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 order to minimize the damage caused by adverse effects, it is necessary to decide in advance what to do in case of an emergency.
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 quasi-drugs 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 quasi-drug manufacturers and distributors to:
These are mandatory;This does not preclude implementation of other matters (self-inspection, education and training, etc.).
(Quasi-drug manufacturers and distributors fall under the category of "Third Type Marketing Authorizer" under the GVP Ministerial Ordinance.)
| number | Message | ministerial ordinance |
| 1 | have sufficient personnel; | GVP Ministerial Ordinance Article 13 (applied mutatis mutandis pursuant to Article 15) |
| 2 | Things to be done by the general manufacturing and sales manager | GVP Ministerial Ordinance Article 3 (applied mutatis mutandis pursuant to Article 15) |
| 3 | Appointment of a safety manager | GVP Ministerial Ordinance Article 13 (applied mutatis mutandis pursuant to Article 15) |
| 4 | What the safety manager must do | GVP Ministerial Ordinance Article 6 (applied mutatis mutandis pursuant to Article 15) |
| 5 | Implementation of safety management operations | 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 management 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 work, and who has the ability to handle quasi-drugs.Persons who do not belong to departments related to sales
A person who is not likely to interfere with the proper and smooth performance of other safety assurance operations shall be appointed as the safety management officer.
4: Have the safety manager do the following:
・Safety assurance workSupervisionTo
・Safety ensuring 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. ・Appropriately evaluate proposed safety measures, decide on safety measures, and create and preserve records. 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 set out in advance the necessary matters regarding the implementation of safety measures in writing. ・If the safety management manager is to take safety measures, he/she shall be instructed in writing regarding the implementation and shall be required to preserve it. ・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.
What is GQP?
GQP is a documented procedure that defines 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").
Conforming to the GQP Ministerial Ordinance For quality control of quasi-drugs, 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 quasi-drug manufacturers and distributors to:
This is a mandatory item and does not prevent other items (self-inspection, education and training, etc.) from being implemented.
| number | Message | ministerial ordinance |
| 1 | have sufficient personnel; | GQP Ministerial Ordinance Article 4, Paragraph 1 (applied mutatis mutandis pursuant to Article 19) |
| 2 | Things to be done by the general manufacturing and sales manager | GQP Ministerial Ordinance Article 3 (applied mutatis mutandis pursuant to Article 19) |
| 3 | Appointment of quality assurance manager | GQP Ministerial Ordinance Article 17 |
| 4 | What the quality assurance manager should do | GQP Ministerial Ordinance Article 8 (applied mutatis mutandis pursuant to Article 19) |
| 5 | Creation of quality control work procedures | GQP Ministerial Ordinance Article 18, Paragraphs 1 and 3 |
| 6 | Implementation of quality control operations | GQP Ministerial Ordinance Article 18, Paragraph 2 |
| 7 | Document and record management | GQP Ministerial Ordinance Article 16 (applied mutatis mutandis pursuant to Article 19) |
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 quasi-drugsPersons 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 Matters necessary for manufacturers and distributors to perform quality control operations, such as procedures for self-inspection, education and training, mutual cooperation with safety management managers, preparation of quality standard documents, and agreements with manufacturers. To create. |
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 through on-site inspections based on agreements, etc., and create a record of this.
③Processing quality information and creating records
When we receive information regarding quality, etc. (including complaints, etc.),
Evaluate and investigate the causes of the effects of the information on human health,
If improvements are necessary, take necessary measures. We will 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 quality defects or the possibility of such defects are found, we will promptly take necessary measures such as recall.
Create a record of it. In addition, if there is no description regarding the lot in the "Shipping Records",
All lots that may be distributed in the market will be covered without limiting the lot.
7: Document and record management
・Documents and records related to quality control shall be changed from the date of creation (for quality control work procedures, the date they are no longer used).5 yearsTo save.
- When creating or revising a document, approve, distribute, preserve, etc. the document.
・The quality control work procedure manual includesCreatoras 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.
For inquiries regarding approvals and approvals regarding quasi-drugs, please contact Support Administrative Scrivener Corporation.
At the Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the quasi-drug industry to existing marketing distributors, manufacturers, and distributors. Masu.
Applications for quasi-drugs 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.
Our dedicated staff handles cases nationwide.
