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

Manufacturing

Our approach to manufacturing: high-quality drugs in stable supply at competitive cost

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.

Initiatives to improve manufacturing quality

To consistently deliver a stable supply of high-quality drugs, Shionogi 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 obtains a GMP compliance certificate for all products before initiating drug manufacturing at our facilities.
At our manufacturing facilities, each lot is subject to 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.
  1. ※1
    GMP: 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 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 Shionogi’s 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 a company that patients can have confidence in and all stakeholders can trust.

A socially responsible system of quality management

To strive constantly to supply the best possible medicine 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. Among the quality risk scenarios envisaged, some are associated with the launch of new businesses and the establishment of new Group companies. Anticipating potential risk and devising mitigating measures makes it possible to respond appropriately and minimize the impact if and when the risk materializes. Through the Shionogi Group Quality Policy, which is subject to continuous improvement, Shionogi 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.
Additionally, to implement these activities Group-wide, including in overseas operations, we put in place a quality assurance system compliant with the regulation of the relevant country. In addition to presenting a unitary policy, we also operate integrated information management, thus realizing a global quality assurance system for Shionogi products.
[Quality Assurance Management] Investigational drugs, Drug manufacturing sites, Raw material manufacturers, Medical institutions, etc. ⇄ [Response from regulatory authorities] Ministry of Labour, Health and Welfare, Overseas regulatory authorities

Building a pharmacovigilance system

Pharmacovigilance system

As set out in the Shionogi Group Drug Safety Policy, Shionogi 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 which allows necessary safety measures to be rolled out rapidly through close coordination between safety management divisions in all Group regions, including overseas. Additionally, for drugs where it is considered necessary, a special pharmacovigilance system is put in place with specific procedures stipulated for the individual product. Through measures of this kind, we promote proper use tailored to the specific characteristics of the 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, 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

[Pharmacovigilance (PV)] Adverse event Information gathering, Adverse event Evaluation and review, Adverse event Review and decision, Safety Information provision (→ Patients Healthcare professionals) ⇄ [Adverse event report/safety measures] Ministry of Labour, Health and Welfare, Overseas regulatory authorities