Supply Chain Management
To ensure that corporations fulfill their social responsibilities, it is important for them to build relationships of trust and to cooperate not only within their own companies but also with suppliers, who are important business partners. At Shionogi, we are collaborating with our suppliers based on the Group’s Procurement Policy, which sets out a basic approach designed to ensure that procurement activity is founded on honesty, fairness, equity, and transparency, and strengthening supply chain management while working to realize a sustainable society.
Initiatives Covering the Supply Chain
At Shionogi, we are aware of the extreme importance of collaborating with our suppliers if Shionogi is to achieve continuous growth hand in hand with society as a drug-discovery-based pharmaceutical company. Therefore, in accordance with our procurement policy, we ask our suppliers to adopt Code of conduct for third party.
The basic principles adopted under the PSCI cover a comprehensive range of fields, including not only environment and health and safety but also human rights and labor, ethics, and their associated management systems. In 2020, the principles were revised, and further items added. Shionogi will continue to support the revised principles and strongly urge all suppliers to endorse them.
PSCI Principles (Extracted items only)
- 1ANTI-BRIBERY AND CORRUPTION
- 2FAIR COMPETITION
- 3ANIMAL WELFARE
- 4DATA PRIVACY AND SECURITY
- 5PATIENT SAFETY AND ACCESS TO INFORMATION
- 6CONFLICTS OF INTEREST
[Human Rights and Labor]
- 1FREELY CHOSEN EMPLOYMENT
- 2CHILD LABOR AND YOUNG WORKERS
- 4FAIR TREATMENT
- 5WAGES, BENEFITS AND WORKING HOURS
- 6FREEDOM OF ASSOCIATION
[Health and Safety]
- 1WORKER PROTECTION
- 2PROCESS SAFETY
- 3EMERGENCY PREPAREDNESS AND RESPONSE
- 4HAZARD INFORMATION
- 1ENVIRONMENTAL AUTHORIZATIONS AND REPORTING
- 2WASTE AND EMISSIONS
- 3SPILLS AND RELEASES
- 4RESOURCE USE
- 5SUSTAINABLE SOURCING AND TRACEABILITY
- 1COMMITMENT AND ACCOUNTABILITY
- 2LEGAL AND CUSTOMER REQUIREMENTS
- 3RISK MANAGEMENT
- 5TRAINING AND COMPETENCY
- 6CONTINUAL IMPROVEMENT
- 7IDENTIFICATION OF CONCERNS
At Shionogi’s manufacturing and research sites, we conduct environmental impact assessment regarding all aspects of their operations from the purchase of raw materials to disposal. Our awareness raising targets not only high-risk in-house operations but also outsourced services, waste disposal operators and other related parties. An emergency communication system is also established between Shionogi and its suppliers.
Our Suppliers’ EHS/CSR Management Guidance sets out EHS risk categories and risk management procedures for suppliers and stipulates which conditions they must meet according to their assigned management level. For important investigational new drugs and pharmaceutical raw material suppliers, we carry out surveys using the PSCI’s self-assessment questionnaire (SAQ)—to confirm the supplier’s status in areas including ethics, human rights and labor, environment, health and safety, and their management systems—in conjunction with on-site
audits. When conducting on-site audits, we also perform risk confirmation for each supplier, such as safety assessments of their manufacturing processes and assessments of locally applied laws and regulations.
So far, we have had 35 suppliers consent to the basic principles adopted for the PSCI and undergo SAQ-based written audits. Subsequently, visits were made to 20 of the suppliers, and on-site audits completed. We will continue working to strengthen relationships while building relationships of trust with suppliers and aiming to realize a sustainable society together with them.
Supplier Management Level and Auditing Items
|No.||Category (by handled products)||Management level||Auditing items implemented|
|Written confirmation||Questionnaire survey||On-site audit|
|1||Suppliers of API, intermediates or preparations (GMP[*2]–conforming process) for drugs developed since the adoption of PV[*1]–based manufacturing||High||◯||◯||◯|
Suppliers of API, intermediates or preparations (GMP-conforming process) for new products
Suppliers other than the above
(Manufacturers of general-use raw materials, subcontractors in charge of packaging, etc.)
- ※1PV: Process validation; confirmation and documentation that the process is valid for permanently manufacturing products of the target quality when operated under a permissible range of conditions set based on the results of industrialization research, the past manufacturing records of similar products, or other such data and in consideration of variables likely to affect the preset product quality (physical properties of raw and other materials, operating conditions, etc.)
- ※2GMP: Good Manufacturing Practice: international standards for the manufacturing and quality control of pharmaceutical products; the GMP-conforming manufacturing of pharmaceutical products is required to follow GMP procedures and guidelines concerning operations such as the delivery of raw materials, inspection, manufacturing, packaging, shipment management, storage, and collection and disposal.