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Quality Management

As a pharmaceutical company involved with human life, we place top priority on ensuring that patients and healthcare professionals can use our products safely. Quality is placed first to guarantee efficacy and safety at every stage from product R&D to manufacturing and distribution.

As a matter of course we comply with all laws, government regulations, and industry standards. We also actively work to gain international certifications and have put in place a rigorous quality management system that takes into account the characteristics of each product.

We ensure that everyone working in the areas of manufacturing and quality assurance feels a strong sense that they play an important role in providing medical treatment. This sense of responsibility, combined with thorough quality management, assures that we are capable of stably delivering safe, high-quality products to patients and healthcare professionals.

Quality and Safety Management Systems

Compliance with laws, government regulations and industry standards

Pharmaceutical and Medical Device Act
A law designed to assure the quality, efficacy, and safety of pharmaceuticals, quasi drugs, cosmetics, and medical devices
GLP (Good Laboratory Practice)
A standard for ensuring reliability in safety-related non-clinical testing
GMP (Good Manufacturing Practice)
A manufacturing control and quality control standard (pharmaceuticals, quasi drugs)
QMS (Quality Management System)
A manufacturing control and quality control standard (medical devices, in vitro pharmaceutical products)
GQP (Good Quality Practice)
A quality control standard
GCP (Good Clinical Practice)
A clinical testing standard
GVP (Good Vigilance Practice)
A post-marketing safety management standard
PV (Pharmacovigilance)
The activities relating to drug-related safety problems
GDP (Good Distribution Practice)
A standard related to the distribution of pharmaceuticals
Food Sanitation Act
A law for assuring food safety that stipulates standards, labeling, testing, etc. of foods and additives, etc.

Certifications

ISO 9001
A standard for building and consistently improving a quality management system for products and services
ISO 13485
A quality management system standard for the medical field aimed at the consistent manufacturing and supply of safe, effective medical devices
ISO 22000
A food safety management system (FSMS) that enables the supply of safe foods to consumers
HACCP
An international standard developed by the Codex Alimentarius Commission regarding sanitary control methods for assuring food safety

Plans of the Otsuka Group and Otsuka Pharmaceutical Factory

  • To draft a Quality Policy
  • To draft a Code of Conduct
  • To build a Total Quality Management System (TQMS) for pharmaceuticals and medical devices
  • To establish a traceability system
  • Employee education

Life Cycle and Regulations in the Pharmaceutical Manufacturing Process

In pharmaceutical R&D, we comply with regulations (GLP, GCP) regarding clinical and non-clinical testing, and demonstrate not only the efficacy of candidate pharmaceutical substances but their guaranteed safety. We also strive to improve reliability through proper data management. We aim to build and implement a GMP system for manufacturing that will allow us to maintain the high quality of our products and consistently improve on that quality. From manufacturing through to marketing, based on GQP, GVP, and GDP, we implement quality management, post-marketing safety management, and distribution management, and prepare and update reports and documentation that we submit to the regulating authorities. We also practice pharmacovigilance, i.e., safety monitoring that involves constantly collecting and evaluating product safety data, the results of which we promptly share with medical organizations and distributors.

Our Global Quality Assurance System for IV Solutions

Around the world today, strict standards are being rapidly established with regard to the quality and safety of pharmaceuticals, and there are especially strong calls for rigorous quality control of IV solutions, as products which are injected directly into the body. As the leading manufacturer of IV solutions in Japan, and being in the position of providing technical cooperation for and managing the IV business of the Otsuka Group that is active internationally, we have established and proactively operate a robust global quality assurance system. A framework for exchanging safety data has been established for the 15 group companies engaged in our IV business across 10 countries. In addition to complying with the laws and government regulations of each country, and industry standards, we are working as one to unify our approach to quality assurance and steadily maintain and improve product quality.

Global Quality Assurance Officers' Meeting

A Framework for Listening to Stakeholders

At Otsuka Pharmaceutical Factory, a dedicated department corresponding to the nature of the inquiry handles inquiries from patients, their families, medical personnel, and other stakeholders. We take great care to listen sincerely to people's perspectives, and strive to provide answers in a polite, honest, easy-to-understand way. We promptly give the information we acquire on safety and quality from these calls to the pertinent department. We also provide information to callers on monitoring risks and proper use, while using the feedback they give us to improve and develop products.

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