[Updated] Japan Approves the Amendments to Good Manufacturing Practice for Quasi-drugs

On Apr. 30, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) officially approved the Ministerial Ordinance on the Good Manufacturing Practice for Quasi-Drugs and Pharmaceuticals. The amendments to the Good Manufacturing Practice for quasi-drugs will take effect on August 1^st 2021.

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On Nov. 27, 2020, Japan Ministry of Health, Labour and Welfare (MHLW) released the amendment to the Ministerial Ordinance on the Good Manufacturing Practice for Quasi-Drugs and Pharmaceuticals (hereinafter referred to as updated GMP Ministerial Ordinance) for public consultation. Advice and suggestions should be submitted before Dec. 26, 2020.

This updated GMP Ministerial Ordinance consists of 3 chapters and 53 articles. Compared with the previous edition, it refines the compliance requirements for the manufacturing and quality management of the manufacturing facility of pharmaceuticals and quasi-drugs, which includes

validation, deviation, recalling and self-inspections. Quasi-drugs, as they are called in Japan, are in-between cosmetics and pharmaceuticals with a wide variety of functions ranging from deodorants to bath products to medicated cosmetics.

The key points of the amendments are as follows:

1. Increases requirements to provide quasi-drug product standard code and procedure manuals

As per the updated GMP Ministerial Ordinance, the domestic and foreign manufacturers of quasi-drugs must carry out manufacturing and quality management of the products at their factories following the new requirements.

The manufacturing department and a quality department must be established at each factory, under the supervision of a "technical supervisor".

Quasi-drug product standard code

The product standard code is a document stipulating specifications and requirements for each product, which complies with the quality control supervision system.

Each quasi-drug product (except intermediate product (products still in process and aren’t sellable)) need to be equipped with a quasi-drug product standard code, which shall be prepared by the manufacturer under the approval of the quality department.

The quasi-drug product standard code includes the following four items.

1. The manufacturing method, standard, test method and other necessary items at the factory;

2. The properties, quality criteria, performance established by the Minister of Health, Labour and Welfare. And others related to quality;

3. Manufacturing procedure (excluding the first item);

4. Other requirements. 

Procedure Manual

In order to ensure the safety and quality of quasi-drug products, GMP stipulates that enterprises must strictly follow the following procedure manuals.

The updated GMP Ministerial Ordinance added that quasi-drug manufacturers should create procedure manuals involving the following procedures.

1. Procedures for hygiene management of structural equipment and staff;

2. Procedures related to the manufacturing process, manufacturing equipment, ingredients, materials and product management;

3. Procedures for test verification equipment and sample management, and other procedures necessary for test verification;

4. Procedures for managing delivery from the factory;

5. Validation procedures;

6. Procedures for managing changes;

7. Procedures for managing deviations from the Manuals;

8. Procedures related to quality and quality defects processing;

9. Procedures for the recall handling;

10. Procedures for self-inspections;

11. Procedures for training;

12. Procedures for creating, revising and storing documents and records;

13. Other procedures related to manufacturing and quality control work;

In case of any change occurred in manufacturing, the content of product standard code and procedure manuals shall be timely modified. It’s essential to ensure that the products meet the requirements of the GMP.

2. Increases requirements for tests and inspections

If the following two conditions can be met at the same time, the mandatory tests and inspections (except appearance inspections) can be replaced by tests and inspection records of the foreign manufacturers.

• The manufacturing management and quality management standards of the importing country are the same as those in Japan.

• The related procedures for confirming compliance with these standards, are the same as those in Japan.

In this case, the quality department of the manufacturer shall properly perform the following duties.

1. Periodically confirm that the imported product is manufactured at the manufacturing site of the foreign manufacturer according to appropriate manufacturing procedures;

2. Periodically confirm that the manufacturing site of the foreign manufacturer complies with the standards for manufacturing management and quality management in that country;

3. Make a record of the confirmation of the preceding two items and retain it;

4. Confirm the record of the tests and inspections conducted by the foreign manufacturer on the imported product, and make a record of the confirmation and retain it.