Otsuka Pharmaceutical Factory pursues initiatives to maintain and improve quality, working closely with the Group’s seven international plants that manufacture I.V. solutions. The international plants are mainly based in Asia and engage in good manufacturing practices (GMPs) to secure quality control in the manufacturing of pharmaceuticals. Until now, however, the specific practices have varied slightly from country to country.
In fiscal 2011, Group companies held an international meeting to discuss the Group-wide adoption of an internationally harmonized GMPs, which requires the updating of quality assurance systems in and outside of Japan. The Group’s nine plants in seven countries are working together to implement these updates and stay abreast of internationalization trends. The changes will make it possible for the plants to assume responsibility for supplying I.V. solutions based on an internationally harmonized GMP.

Otsuka Pharmaceutical Factory endeavors to be a best partner of both patients and healthcare professionals in the field of clinical nutrition products. In particular, the company has focused on developing kits that help to reduce medical accidents and infection, while simplifying administration by medical practitioners. For example, the company developed ELNEOPA No. 1 injection and ELNEOPA No. 2 injection solutions in 2009. The products are packaged in an innovative quad-bag kit formulation and are the world’s first high-calorie injection solutions formulated with vitamins and trace elements.
Certain types of vitamins lose their stability when formulated with trace elements, which Otsuka Pharmaceutical Factory addressed by developing quad-bag kits that greatly improve the stability of vitamins after mixing. The company will continue to develop other products that deliver superior quality and safety together with convenience.

Otsuka Pharmaceutical is reducing the weight of PET bottles, focusing on 500 ml eco-bottles made from preforms.^* The company’s plants employ different systems, including use of in-house blow molding machines to open up preforms. In some cases the preforms are manufactured in-house. The latter eliminates energy expenditure and chemical use that is otherwise needed for bottle washing.
In addition, a method called positive pressure aseptic filling is being used. This enables filling at room temperature, which improves the flavor of beverages. Otsuka Pharmaceutical will continue working to develop manufacturing systems that raise quality and that are friendlier to the environment.

• * Preforms are test tube-shaped plastics that are expanded into a mold and formed into PET bottles.

Initiatives to secure food safety and security are increasingly critical today, in light of the increasing importance of global procurement for securing the stable supply of basic ingredients for food production. Otsuka Foods, which manufactures products such as Java Tea and Bon Curry, operates traceability systems and identifies the origin of raw materials and the processes it uses.
In fiscal 2010, the company inspected management practices at tea plantations in Indonesia and checked pesticide management and usage. In China, the company inspected the safety of Chinese raw materials with the cooperation of Otsuka (Shanghai) Food Safety Research & Development, which has acquired CNAS certification.^*

• * Laboratory accreditation based on the ISO/IEC 17025, the global standard for testing and calibration laboratories, given by the China National Accreditation Service (CNAS)

Otsuka Pharmaceutical has improved the efficiency of baking ovens used to make Calorie Mate and SOYJOY products, replacing gas ovens with new ovens that use both gas and heat transmission from steam.
The new ovens achieve faster baking times, increasing production capacity approximately 1.6 times, while also improving the texture of goods through more even browning. Otsuka Pharmaceutical will pursue other initiatives in an effort to further reduce energy expenditure.