To ensure that corporate social responsibility is fulfilled, as well as monitoring its own organization, Shionogi needs to build relationships of trust and cooperation with suppliers, who are important business partners. The Shionogi Group’s Procurement Policy sets out a basic approach designed to ensure that procurement activity is founded on honesty, fairness, equity, and transparency, and forms the basis on which we work together with suppliers to strengthen supply chain management.

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 PSCI PRINCIPLES FOR RESPONSIBLE SUPPLY CHAIN MANAGEMENT refers to the Pharmaceutical Industry Principles for Responsible Supply Chain Management (“Principles”), proposed by PSCI,[*1] a non-profit organization comprising over 40 pharmaceutical companies around the globe and advocating CSR procurement[*2] in the pharmaceutical industry. The Principles cover a wide range of areas, including not only the environment, health and safety, but also ethics, workers’ rights, management systems concerning these values. Shionogi endorses and acts in accordance with all of the Principles.

PSCI Principles (Extracted items only)

[Ethics]

  1. 1
    ANTI-BRIBERY AND CORRUPTION
  2. 2
    FAIR COMPETITION
  3. 3
    ANIMAL WELFARE
  4. 4
    DATA PRIVACY AND SECURITY
  5. 5
    PATIENT SAFETY AND ACCESS TO INFORMATION
  6. 6
    CONFLICTS OF INTEREST

[Human Rights and Labor]

  1. 1
    FREELY CHOSEN EMPLOYMENT
  2. 2
    CHILD LABOR AND YOUNG WORKERS
  3. 3
    NON-DISCRIMINATION
  4. 4
    FAIR TREATMENT
  5. 5
    WAGES, BENEFITS AND WORKING HOURS
  6. 6
    FREEDOM OF ASSOCIATION

[Health and Safety]

  1. 1
    WORKER PROTECTION
  2. 2
    PROCESS SAFETY
  3. 3
    EMERGENCY PREPAREDNESS AND RESPONSE
  4. 4
    HAZARD INFORMATION

[Environment]

  1. 1
    ENVIRONMENTAL AUTHORIZATIONS AND REPORTING
  2. 2
    WASTE AND EMISSIONS
  3. 3
    SPILLS AND RELEASES
  4. 4
    RESOURCE USE
  5. 5
    SUSTAINABLE SOURCING AND TRACEABILITY

[Management Systems]

  1. 1
    COMMITMENT AND ACCOUNTABILITY
  2. 2
    LEGAL AND CUSTOMER REQUIREMENTS
  3. 3
    RISK MANAGEMENT
  4. 4
    DOCUMENTATION
  5. 5
    TRAINING AND COMPETENCY
  6. 6
    CONTINUAL IMPROVEMENT
  7. 7
    IDENTIFICATION OF CONCERNS
  8. 8
    COMMUNICATION
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.
We perform EHS audits on suppliers of important active pharmaceutical ingredients (API), confirming the safety measures and environmental consideration in their manufacturing processes and other aspects. We have drawn up “Suppliers’ EHS/CSR Management Guidance,” which stipulates EHS risk categories and management procedures for suppliers, as well as auditing items to be implemented at each supplier management level (Table 1). For questionnaire surveys, we use PSCI’s Self-Assessment Questionnaire (SAQ) forms to check items such as ethics, labor, environment, and health and safety.
In FY 2018, we had the honor of having 24 suppliers respond to the Principles favorably, with whom we conducted written audits using questionnaire survey forms. With nine of them, the audits were conducted as on-site audits at their facilities. We intend to continue to enhance our supplier management through various means, including participation in auditor training programs organized by PSCI.
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    
  1. ※1
    PV: 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.)
  2. ※2
    GMP: 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.