Quality Assurance

Fundamental Philosophy and Policies

To ensure the peace of mind and satisfaction of our consumers, it is essential that all employees carry out their work earnestly in a manner based on our shared philosophy. The Company defines our fundamental philosophy in quality assurance on the basis of management philosophy, comprehensive in all concepts related to reliability.

To realize this fundamental philosophy, the Company:

1. At all times takes the opinions of all our consumers with the highest sincerity, and puts these into action to improve our quality and safety management.
2. Acquires all the latest knowledge in response to the progress and changes in quality assurance practices that have accompanied the progress in science and technology and diversification of products.
3. Establishes a cooperation framework between the departments involved, clarifies the framework of responsibilities, and at all times revitalizes the organization to allow several departments working cooperatively to proceed in their tasks.

For this purpose, 1 to 3 above were established as our fundamental policy in quality assurance work, and we always strive to develop and strengthen the quality assurance systems even further.

Basic Principle of Quality Assurance

We constantly strive to ensure product efficacy and safety and to improve product quality from the consumers’ perspective. We are also dedicated to the peace of mind and satisfaction of our customers. This commitment to this responsibility is unwavering.

Policies for Quality Assurance

1. Stance: We will listen to consumers’ opinions and meet their expectations.
2. Technology: We will constantly aim for the most advanced technology, adopting a global perspective.
3. Management: We will constantly work on self-management activities that ensure the reliability of our activities.

Quality Policy

We continue to provide products high in quality, efficacy, and safety that earn the trust of our consumers, and bring them peace of mind and satisfaction.

Quality Assurance Framework

In full compliance with the spirit established at its foundation, the Group believes that providing products, services and information that are reliable to all consumers is the Group’s social responsibility. To fulfill this responsibility, first each area of business concerning our products, research and development, manufacturing and sales, is in compliance with the relevant laws and regulations, where the highest priority must be placed on the effectiveness, safety and quality assurance of the products. In addition, in order for all consumers to have trust in these areas of our business, it is essential that we firmly look over our processes from the consumers’ perspective. The work we conduct in this area is our quality assurance.

At Taisho Pharmaceutical, our Quality Assurance Headquarters, having become independent from our research and development, manufacturing and sales lines, is placed at the center and seeks to maintain and improve our system of promoting quality assurance. Pushing forward daily in this work, we are committed to delivering products, information and services that can receive a high level of trust from all consumers.

Quality Assurance Organization for Taisho Pharmaceutical Holdings and Taisho Pharmaceutical

• * GCP (Good Clinical Practice): Standards for conducting clinical trials

Roles of the Quality Assurance Headquarters

In the research and development stage, various tests to evaluate the efficacy and safety of our products are carried out using the appropriate methods, and other methods are developed to produce high-quality products. We find it highly important that these records are kept in a form where reliability is guaranteed. The Non-Clinical Quality Assurance Section and GCP* Audit Section are responsible for this quality assurance. In the manufacturing and sales stage, our products are manufactured and shipped using the appropriate equipment and predetermined procedures, and further down the line, the Product Quality Assurance Division is constantly monitoring that the products sold on the market are of our guaranteed level of quality. In addition, to promptly deliver to all consumers and medical professionals information regarding the proper use of our products and safety information, information relating to product efficacy and safety is collected, examined and evaluated, and the work to take the appropriate measures is carried out. Taisho Pharmaceutical, taking into account differences in product characteristics and sales forms, sets up specialist organizations and performs the work responsibilities of each. These organizations include the Prescription Drug Pharmacovigilance Division and Postmarketing Surveillance Division responsible for medical pharmaceuticals as well as the Self-Medication Pharmacovigilance Division in charge of OTC drugs, quasi-drugs, cosmetics, medical equipment and food.

Initiatives at Group Companies in Japan and Overseas

To promote quality assurance and safety management at a high level at Group companies both in Japan and overseas, Taisho Pharmaceutical built a management system centered on the Head Office. We are also actively working to create a global pharmaceutical quality assurance system. In addition, we are creating a pharmacovigilance system with enhanced collaboration between Head Office and Group companies to assess and review safety properly and to take appropriate safety measures to ensure that people overseas can use our pharmaceuticals safely and with peace of mind.

We comply with the laws and regulations of each country, share our fundamental philosophy throughout the Group, and work to provide products, information and services that our customers overseas can rely upon.

Employee Training on Quality Assurance and Product Safety

Taisho Pharmaceutical has set procedures for training and is providing education for persons engaged in quality control and safety management following production and sale based on the GQP^*1 and GVP^*2 ministerial ordinances.

We implement ongoing training programs that include education for those involved with quality control under the guidance of a quality assurance officer aimed at imparting the basic knowledge necessary for the proper execution of operations on a day-to-day basis as well as on-the-job audit training and education through outside instructors.

At the same time, we provide product safety education under the responsibility of a self-medication pharmacovigilance officer and a prescription drug pharmacovigilance officer. We are continuously giving education to employees engaged in after-sales safety management to ensure the ability to perform duties and properly carry out safety assurance-related tasks, thus guaranteeing reliability. Employees appointed to a quality control or safety management position shall pass a test to check their understanding following introductory education before commencing the job.

Taisho Pharmaceutical provides opportunities for education to all employees each year, believing that we need to provide training for the prevention of drug-induced diseases, quality control/after-sales safety management as part of our mission as a pharmaceutical company. Through this education and training, we seek to raise awareness among all employees.

• *1. GQP (Good Quality Practice): Ministerial ordinance on standards for quality control for drugs, quasi-drugs, cosmetics and regenerative medicine products
• *2. GVP (Good Vigilance Practice): Ministerial ordinance on after-sales safety management for drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine products

Ensuring Reliability in Clinical Trials

Taisho Pharmaceutical has formulated a framework for conducting clinical trials that is based on relevant laws and regulations such as the Pharmaceuticals and Medical Devices Act, ICH-GCP^* and GCP for countries conducting clinical trials. This framework clarifies our policy of prioritizing subjects’ human rights, stipulates such areas as persons of responsibility and committees, and seeks to secure the reliability of data used in clinical trials with clear assignment of responsibilities and roles.

• * ICH-GCP: Good Clinical Practice (GCP) as stipulated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)