Ensuring quality and safety in products and services

This page covers our manufacturing and quality management initiatives to ensure quality and safety in products and services.

To put into practice the Company Policy, we take Safety, Quality, Delivery, Low Cost, and Environmental Consciousness as the basis of our manufacturing activities. Going forward, we will continue to maintain an awareness of these five principles as we pursue earnest initiatives to realize a stable supply of high-quality drugs at reduced cost.

To consistently deliver a stable supply of high-quality drugs, SHIONOGI Group has put in place a quality assurance system based on Japanese and overseas GMP*, allowing us to pass the inspections of regulatory authorities in the US and Europe. Each drug product must undergo an individual inspection for compliance with GMP. SHIONOGI Group obtains a GMP compliance certificate for all products before initiating drug manufacturing at our facilities.

GMP compliance certification covers the pharmaceutical quality system in accordance with the ICH Q10 guideline. This pharmaceutical quality system is based on the principles of ISO 9001, because ICH Q10 utilizes ISO 9001 as the foundation for creating guidelines.

At our manufacturing facilities, each lot is subject to in-house tests and inspections to monitor product quality at every stage from receipt of raw materials through to the finished product. We also perform quality trend assessment and stability monitoring in an effort to realize continuous quality improvement. All data relating to drug manufacturing and quality are subject to appropriate document management to ensure the completeness of data as part of a system to consistently deliver the best possible medicines.

* GMP: Good Manufacturing Practice (regulations for pharmaceutical manufacturing control and quality control)

The mission in corporate quality management activity is to ensure compliance with all regulations in operations relating to quality, safety, and pharmaceutical regulatory affairs, and to thereby ensure the reliability of these activities across the whole Group. This means that it coordinates closely with Group companies worldwide in the US, Europe, Asia, and other regions, working to improve the quality of SHIONOGI Group products and information, ensure safety through a robust pharmacovigilance system, and implement pharmaceutical compliance in the rapidly changing regulatory environment. In this way, it helps to fulfill our responsibilities as a corporate citizen.

Based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), SHIONOGI has built a management system centered on the General Manager of Manufacturing and Marketing under the responsibility of designated executives, with the three key manufacturing and marketing roles. We conduct planned audits of supply chains including domestic and international manufacturing sites, and by collecting and evaluating post-marketing safety information, strive for regulatory compliance and quality/safety assurance to provide highly reliable products and services.

Going forward, we will continue to comply with regulations and take advance measures to avoid risk so as to make SHIONOGI Group a company that patients can have confidence in and all stakeholders can trust.

At SHIONOGI, we consider quality as one of our important corporate values and working to foster a quality culture including at Group companies and to advance a mindset of rigorous compliance not only within the Group but also in the supply chain.

In collaboration with domestic and international manufacturing sites including Shionogi Pharma Co., Ltd., we share quality improvement initiatives and deepen understanding through audits and regular educations.

We also create opportunities for self-reflection through factory visits and workshops with other companies in the industry, promoting Quality Culture development.

In addition, in accordance with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), the roles and scope of responsibility of the officer in charge are clearly defined, and annual training on legal compliance for all employees is conducted under an appropriate management system based on the three-role system of Pharmaceutical Officer, Quality Assurance Supervisor and Safety Supervisor.

Additionally, we hold the Global Compliance & Quality Week annually across the entire Group, promoting understanding of the importance of data integrity through events and always advancing quality activities based on regulatory compliance.

We conduct systematic on-site or remote audits of plants and manufacturing contractors in Japan and overseas, and conduct ad hoc audits of plants and manufacturing contractors where serious events have occurred in the past; thereby ensuring that management supervision is con[1]ducted efficiently and with a high level of quality.

To strive constantly to supply the best possible medicines to protect the health and wellbeing of the patients we serve, businesses must act efficiently with an approach to risk that takes preventive measures in advance rather than reacting after an issue has emerged. Through the SHIONOGI Group Quality Policy, which is subject to continuous improvement, SHIONOGI Group confirms that all products and data in Japan and overseas, from the development to the post-marketing stage, are covered by appropriate risk-preventive action of this kind.

We have also built a system that complies with the laws and regulations of each country and carry out global quality assurance so that these activities can be carried out by the entire group, including overseas.

To reliably supply high-quality medicines to patients around the world, we are working to improve manufacturing quality and ensure quality through GMP* and developing activities to protect patients from counterfeit medicines. In addition to participating in industry activities related to the prevention of counterfeit medicines, we have set up a Global Anti-Counterfeit Committee centered on members from Japan, the United States, and Europe to work on product security measures.

As set out in the SHIONOGI Group Drug Safety Policy, SHIONOGI Group gives utmost priority to the safety of patients and participants in clinical trials. To minimize risks and maximize the value of pharmaceuticals and medical devices, it is important to continuously cycle pharmacovigilance (PV) activities that collect, evaluate, and examine safety information such as adverse reactions and implement necessary measures such as package insert revisions.

Accordingly, we operate procedures for reliably gathering and evaluating safety information at all stages from development to post-marketing and have put in place a system so that the necessary safety measures can be rolled out rapidly through close coordination among safety management divisions in all Group regions, including overseas. We are currently advancing PV process reform, promoting system strengthening together with PV members from overseas group companies, including quality improvement in clinical trial safety management and consideration of new signal management methods. Additionally, for drugs where it is considered particularly necessary, we have put in place a special pharmacovigilance system with specific procedures stipulated for the individual product.

In order to ensure that safety measures are correctly implemented, it is vital that management and employees understand the importance of gathering and evaluating safety information.

At SHIONOGI Group, in order to handle safety information appropriately, we formulate procedural manuals and provide in-house education. 

We conduct regular education reflecting the latest safety information mainly for medical representatives (MR) in Japan, and response policies, improving appropriate information provision and response capabilities in the field. Also, we conduct annual safety training on pharmaceutical products for management and all employees, working to enhance PV awareness.

Through appropriate education, we work to improve awareness of safety in our business management.