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Quality in all we do -Production and Quality Control-

Basic Policy

The duty of a healthcare company is to always put its customers first. In pursuing product quality and safety, the Otsuka group has established a production and quality control system suited to the characteristics of each of our business lines, namely, pharmaceuticals, foods, beverage, chemicals and, cosmetics.

Approach

The Otsuka group’s production, quality, and safety control systems comply with legal requirements and governmental and industry standards (including Japan’s Pharmaceutical and Medical Devices Act (PMD Act) and Japan’s Food Sanitation Act). The group is also working to acquire international certifications such as ISO9001 for quality, ISO13485 for medical devices, and ISO22000 and FSSC22000 for food safety. Furthermore, in order to ensure thorough quality control, we employ a traceability system covering all stages of the product lifecycle, from raw material procurement to production, distribution, and sale. Group-wide global production meetings are held regularly to share various issues and case examples related to production at our plants in order to provide the latest information about production control and prevent issues from occurring. In addition, we provide regular training to relevant employees from health and safety to GMP*, environmental protection, food safety, compliance, ISO standards, and so on.
Our major group companies that operate on a global scale have also established and operate global quality assurance systems. For instance, Global Product Quality Meeting was held in 2019 at Otsuka Pharmaceutical and attended by around 100 people, including managers and quality supervisors, to discuss quality issues and future initiatives. In our Pharmaceutical Business, we established global product quality policies for each area in 2017. In addition to product quality, we also aim to improve the quality of clinical practices and IT operations that handle clinical data and we are constantly making improvements by globally managing quality benchmarks. In the Nutraceutical Business, we utilize our global network to draw up guidelines and establish benchmarks for monitoring quality control activities and strive to constantly improve quality through mutual knowledge and inspection. Owing to differences in systems and regulations in each country and region, we encourage each of our plants to acquire international standards, such as ISO9001, FSSC22000, and ISO14001 (environment). We also perform internal audits on our plants on a periodic basis.
As for inquiries about our products from customers, we have in place a framework that further improves the value of our products. More specifically, we confirm with our product quality departments about how the product lot was manufactured, analyze the returned item, compare it with other products in storage at the plant, analyze the cause of the issue, and come up with future countermeasures.

*Good Manufacturing Practice