Ensuring quality and safety in products and services
Our approach to manufacturing: high-quality drugs in stable supply at competitive cost
Initiatives to improve manufacturing quality
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[*1], 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.
- ※1GMP: Good Manufacturing Practice (regulations for pharmaceutical manufacturing control and quality control)
A socially responsible system of quality management
The mission in corporate quality mnagement 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.
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.
Quality assurance and response to counterfeit drugs
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.
Building a pharmacovigilance system
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. 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. 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.
Education for improved safety awareness
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. Within Japan, as well as regular training on gathering of safety information designed mainly for medical representatives (MR), we also provide safety education for general employees. In this way we work to improve awareness of safety in our business management.
Safety education: fiscal 2018 achievement record:
Safety control divisions 5 courses; Medical representatives
6 courses; Management 1 course; Company-wide education 1 course