Quality Assurance
GMP Management System
The concept of GMP originated in the United States. It spread worldwide after the World Health Organization (WHO) created GMP standards and recommended their adoption by member countries in 1969.
It is now legally mandated in most countries. In Japan, a comparable standard is the Ministry of Health, Labor and Welfare's GMP Ordinance, established in 1980 based on the Pharmaceutical Affairs Law.
This ordinance has formed the basis for pharmaceuticals manufactured domestically. Pharmaceutical GMP aims to improve public health and hygiene by providing effective, safe, and high-quality pharmaceuticals.
For this reason, the three principles of GMP -- "minimizing human error," "preventing contamination and quality deterioration," and "designing a system to ensure high quality" -- are essential throughout pharmaceutical manufacturing.
The majority of our products are active pharmaceutical ingredients and pharmaceutical intermediates. We boast the world's largest production volumes of pharmaceutical cysteine and its derivatives, and infusion-use L-tyrosine.
Our company has three independent departments that strictly monitor the manufacturing process and product quality, meeting the strict requirements of government agencies and customers not only in Japan but around the world.