Eisai Machinery Division Receives ISO 9001 Certification
Tokyo (June 11, 1997) - The Eisai Machinery Division of Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) today announced the receipt of ISO 9001 certification of the design, development, production, and after service maintenance of the Automatic Inspection Machine (AIM) for quality management and quality assurance on June 6, 1997. In August 1996, Eisai's vitamin E production facilities at the Kawashima Industrial complex received the ISO 9002 certification from the Japan Quality Assurance Organization (JQA) for production and inspection processes. In the UK, the bulk chemical sales subsidiary, Eisai Pharma-Chem Europe Ltd. received certification of meeting ISO 9002 standards from the British Standardization Institute in January 1997.
The Automatic Inspection Machine (AIM), developed by Eisai, automatically inspects ampules and vials containing medicinal products for foreign matter or insufficient drug amounts. Since sales began, Eisai has installed over 630 machines in 38 countries worldwide.
Recently pharmaceutical production process standards in most all countries must meet the stringent Good Manufacturing Practice (GMP) Standards. AIM meets the high standards for the detection of foreign matter and makes contributions to the production of the highest quality pharmaceutical products.
<ISO 9000 Series>
ISO is the abbreviation for the International Organization for Standardization and is a worldwide federation of national standards bodies.
The ISO 9000 is a family of standards or quality management and quality assurance. The ISO 9000 standards represent an international consensus on the essential features of a quality system and not on the product. Over 50 countries worldwide are utilizing the ISO 9000 as national standards.
Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through its global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care systems. The Company reported sales of 281,561 million in 1996 with approximately 14 percent of sales spent for research and development.