Reliability Assurance

Reliability assurance initiatives

The Production & Assurance Division handles compliance with relevant laws and ordinances as well as tasks spanning the entire pharmaceutical life cycle, from the R&D stage through to product launch and beyond. Taking charge of product quality assurance, data reliability maintenance, safety information management, pharmaceutical applications and their maintenance and management, post-manufacture and marketing surveys, and medicine consultations, we strive to ensure the effectiveness and safety of pharmaceuticals.

Reliability assurance system

Through solid coordination between the various reliability assurance divisions under the general marketing supervisor, QA manager, and safety manager, we ensure compliance with the terms of approvals; maintain and manage pharmaceutical manufacturing and marketing licenses; and implement compliance with the GQP,^*1 GVP,^*2 and GPSP^*3 ministerial ordinances. Through these means, we aim to further enhance our manufacturing and marketing systems to ensure product quality, effectiveness, and safety.

• *1 GQP: The abbreviation of Good Quality Practice. A standard for the quality management of, among others, pharmaceuticals, quasi-drugs, cosmetics, and regenerative medicine products. Conformity to this standard is one of the requirements of pharmaceutical manufacturing and marketing licenses.
• *2 GVP: The abbreviation of Good Vigilance Practice. A standard for post-manufacture and marketing safety management of pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic products, and regenerative medicine products. Conformity to this standard is one of the requirements of pharmaceutical manufacturing and marketing licenses.
• *3 GPSP: The abbreviation of Good Post-marketing Study Practice. A standard for post-manufacture and marketing surveys and testing.

Ensuring safety

We have formulated the Risk Management Plan to widely share pharmaceutical risks and management methods with medical professionals. We also continue to collect and assess safety information from all domestic and international sources after marketing to promptly provide everyone involved in the medical field with the information necessary to ensure product safety.