On October 30th and 31st, 2024, Duoc Ha Tay welcomed an inspection team and conducted a simulated inspection at the Hataphar High-Tech Pharmaceutical Factory (Hoa Lac). This is the final step in preparations for the Hataphar High-Tech Pharmaceutical Factory, which is expected to undergo PIC/S-Japan GMP standard assessment in 2025.
The Hataphar High-Tech Pharmaceutical (CNC) factory project, with a capacity of approximately 2 billion pills per year, was commenced by Duoc Ha Tay Joint Stock Company in 2022, designed to meet the Good Manufacturing Practices (GMP) standards of Japan (PIC/S Japan-GMP). With its large scale, modern technology, and strict quality control and assurance processes, the CNC Hataphar factory is expected to be the first pharmaceutical factory in the North to achieve PIC/S Japan GMP standards – along with the EU GMP of Europe or the PIC/S GMP of PIC/S member states, and the USA CGMP of the United States, which are currently among the highest standards in the pharmaceutical industry worldwide.
The simulated inspection team consisted of:
- Ms. Hayasaka Yukari – Quality Assurance Department, Iwaki Factory of ASKA Pharceutical
- Mr. Yasuda Kento – Quality Assurance Department, Iwaki Factory of ASKA Pharceutical
Along with the cooperation of the Board of Directors, the Management Board, and other relevant departments at the Hataphar High-Tech Pharmaceutical Factory
After two days of simulated inspection, all areas of the warehouse, production workshops, administration building, and the production management, quality assurance, and quality system processes of the CNC pharmaceutical factory were inspected and evaluated by the team according to the strict standards of PIC/S Japan GMP and achieved very positive results. This result is thanks to Duoc Ha Tay’s determination from the beginning: to build a new factory that meets the highest standards of Good Manufacturing Practices. This not only contributes to improving the company’s production capacity and enhancing the quality of pharmaceuticals for domestic consumers but also aims to export to the world, including the most demanding markets such as Japan and Europe.
With the positive results from the two-day simulated inspection, The Hataphar High-Tech Pharmaceutical (CNC) factory team is now more determined than ever to secure the PIC/S Japan GMP certification in the year ahead.
