According to leading experts, in order to achieve Japan-GMP standard, enterprises need to meet many strict standards. Products that meet this standard will bring outstanding gold values to users.

Japan-GMP, a symbol of international standard quality

According to Pacific Bridge Medical (PBM), drug quality management is an important issue in Japanese medical market. Japan's quality control and quality assurance requirements are often very strict.

Japan-GMP is a Japanese standard of Good Manufacturing Practice. In Japan, Japan-GMP was established in 1974 and took effects in 1975. Since then, Japan-GMP has been continuously updated to improve its difficulty. In order to achieve Japan-GMP standard, medicine production lines must pass many evaluation steps lasting 16 to 27 months to assess whether they meet this world high-class standard or not.

Japan-GMP is a symbol for Japanese high-quality medicine, directly certified by Japanese Pharmaceuticals and Medical Devices Agency. This standard includes strict requirements on raw materials, aseptic storage of finished products, quality system management according to ICH Q10 standard, proper storage and transportation of drugs, etc. to ensure that each tablet meets the highest quality when it reaches patients, experts said.

 1

Mr. Masashi Nakaura – General Director reports the results on achievements 2020, particularly getting Japan-GMP certification to the shareholders

Accordingly, Japan-GMP standard has been pursued by many domestic pharmaceutical companies. However, cost for investment in this certified medicine production line is many times higher than conventional standards. In addition, enterprises need to comply with many strict and time-consuming requirements to be assessed whether they are successful or not.

Conquer Japan-GMP to bring the most benefits to consumers

Proudly overcoming these challenges, in Vietnam, DHG Pharma is the first pharmaceutical company to be granted Japan-GMP certification. Up to now, there are only three production lines in the country that have passed high-class technical barriers to achieve Japan-GMP certification, of which DHG Pharma owns two.

 1

 1

Representatives of DHG’s Board of Management at Annual General Meeting of Shareholders 2020

Thanks to right investment, any tablet of DHG Pharma produced by two lines is controlled all factors related to quality during production process from receiving raw materials to finishing products that the best quality is reached to users.

All DHG Pharma’s employees involved in these two production lines was trained according to defined functions of the production process with the most modern equipment conditions in the country. Personnel are trained locally as well as abroad to ensure sufficient qualification and ability for smoothly operating two tablet and film-coated tablet production lines meeting Japan-GMP standard.

Furthermore, hygiene principles and practices are strictly followed during the production process and medicines are properly stored and transported to hospitals as well as distribution network of more than 30,000 reputable drugstores across the country and export abroad.

Doctors shared that Japan-GMP was chosen as the priority standard for medicines to enter the mainstream channel in hospitals with the lines of antibiotic, nervous, digestive, hepatobiliary, cardiovascular, respiratory, analgesic and antipyretic drugs. It is worth mentioning that at present, nearly 100 products produced by DHG Pharma on two production lines of tablet and film-coated tablet reaching Japan-GMP standard have been delivered to users with a reasonable price, superior quality and well received by consumers. Typically, the anti-allergic drug Telfor has quick action, causes no drowsiness, no effect on central nervous system and the anthelmintic drug Fubenzon helps to kill worms effectively and helps the body health to be stable.

Accordingly, “Enterprise’s achievements are not only prestigious awards, the satisfaction and trust of customers and people are the best reward we want to receive”, a representative of DHG Pharma shared.

Source: https://www.pacificbridgemedical.com/regulatory-services/medical-device-pharmaceutical/quality-compliance/japan/#:~:text=In%20Japan%2C%20Good%20Manufacturing%20Practice,marketing%20Study%20Practice%20(GPSP).