PSCI Audits

RESPONSIBLE AND SUSTAINABLE MANAGEMENT OF PHARMACEUTICAL SUPPLY CHAINS

Workplace health and safety, ethics, environmental sustainability, and social responsibility have now become common objectives for many companies, whether small businesses or multinationals. Achieving these objectives is regarded as an added value alongside the quality and reliability of the products and services offered.

WHAT IS PSCI (PHARMACEUTICAL SUPPLY CHAIN INITIATIVE)?

The Pharmaceutical Supply Chain Initiative (PSCI) was established in 2006 by a group of major pharmaceutical companies that share the goal of formalizing, implementing, and promoting practices for responsible management of their supply chains, with the aim of ensuring better conditions for workers, safer processes and facilities, economic development, and environmental protection.

PSCI serves as a benchmark initiative for companies across pharmaceutical supply chains that wish to operate in line with industry expectations, in order to enhance and improve their social, economic, and environmental performance. The key principles around which PSCI is organized—and to which suppliers to large pharmaceutical companies are expected to commit—are as follows:

  • Labor
    Suppliers must respect workers’ rights and treat them with dignity and respect

  • Ethics
    Suppliers must conduct their business ethically and act with integrity

  • Health and Safety
    Suppliers must ensure a safe and healthy working environment

  • Environment
    Suppliers must operate in an environmentally responsible and efficient manner to minimize negative environmental impacts. They are encouraged to conserve natural resources, avoid the use of hazardous materials—where possible—and engage in reuse and recycling

  • Management Systems
    Suppliers are expected to develop management systems to facilitate continual improvement and adherence to these principles.

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HOW DOES A PSCI AUDIT WORK?

Typically, large pharmaceutical companies that participate in PSCI identify the suppliers who will be subject to a PSCI audit. The supplier can then contact Bureau Veritas to schedule the audit. For this audit, the main steps to follow are:

  1. Contact Bureau Veritas and plan the audit

  2. Prepare for the PSCI audit

  3. Conduct the PSCI audit

  4. Issue the report and develop the corrective action plan

  5. Share the results

  6. Follow up on corrective actions.

FAQ - FREQUENTLY ASKED QUESTIONS ABOUT PSCI AUDITS

  • WHO CAN BENEFIT FROM PSCI?

    PSCI audits are relevant to—and beneficial for—the following types of organizations:

    • Manufacturers of medicines and pharmaceutical products

    • Producers and suppliers of pharmaceutical precursors

    • Companies operating in biotechnology, life sciences, and the pharmaceutical sector

    • Generic medicine manufacturers

  • HOW LONG DOES A PSCI AUDIT TAKE?

    The duration of a PSCI audit varies with company size:

    • Small companies (up to 100 employees):
      • Social audit: Expect a maximum of 10 employee interviews
      • HSE audit: Typically 1 day

    • Large companies (more than 1,000 employees) with complex production facilities:
      • Social audit: Up to 40 employee interviews
      • HSE audit: Around 2–4 days