Supply Chain Management
Initiatives Covering the Supply Chain
We are happy to announce that SHIONOGI joined in the Pharmaceutical Supply Chain Initiative (PSCI) in August, 2017. The PSCI is a non profit organization which promotes of the CSR procurement※ in the pharmaceutical and healthcare industry. The number of PSCI member companies is on the increase and more than 50 companies join in the PSCI now.
PSCI Principles (Extracted items only)
[Ethics]
- 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
- 3NON-DISCRIMINATION
- 4FAIR TREATMENT
- 5WAGES, BENEFITS AND WORKING HOURS
- 6FREEDOM OF ASSOCIATION
[Health and Safety]
- 1WORKER PROTECTION
- 2PROCESS SAFETY
- 3EMERGENCY PREPAREDNESS AND RESPONSE
- 4HAZARD INFORMATION
[Environment]
- 1ENVIRONMENTAL AUTHORIZATIONS AND REPORTING
- 2WASTE AND EMISSIONS
- 3SPILLS AND RELEASES
- 4RESOURCE USE
- 5SUSTAINABLE SOURCING AND TRACEABILITY
[Management Systems]
- 1COMMITMENT AND ACCOUNTABILITY
- 2LEGAL AND CUSTOMER REQUIREMENTS
- 3RISK MANAGEMENT
- 4DOCUMENTATION
- 5TRAINING AND COMPETENCY
- 6CONTINUAL IMPROVEMENT
- 7IDENTIFICATION OF CONCERNS
- 8COMMUNICATION

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 | ◯ | ◯ | ◯ |
2 | Irreplaceable suppliers Suppliers of API, intermediates or preparations (GMP-conforming process) for new products |
Intermediate | ◯ | ◯ | |
3 | Suppliers other than the above (Manufacturers of general-use raw materials, subcontractors in charge of packaging, etc.) |
Low | ◯ |
- ※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.
Declaration of Partnership Building
We have announced the Declaration of Partnership Building in support of the purpose of the Council on Promoting Partnership Building for Cultivating the Future, which is promoted by the Cabinet Office and the Small and Medium Enterprise Agency. We aim to build new partnerships by promoting cooperation, coexistence, and co-prosperity with our suppliers in the supply chain and businesses seeking to create value. Please see below for details.
SHIONOGI's Declaration of Partnership Building
Reference: The Portal site of Declaration of Partnership Building (Japanese site)