Audit methodology · Last verified
Pharmaceutical Supply Chain Initiative
PSCI is a non-profit membership organization whose members share third-party supplier audits across the pharmaceutical and healthcare value chain. Its two parts are the PSCI Principles for Responsible Supply Chain Management and the shared audit program; the output the owner describes is a standardized audit report plus an agreed Corrective Action Plan.
- Class
- Audit methodology
- Owner
- Pharmaceutical Supply Chain Initiative (PSCI)
- Last verified
What it is
PSCI publishes two things. The first is the PSCI Principles for Responsible Supply Chain Management, grouped into five areas — ethics, human rights, health and safety, environment, and governance and management systems — which members are expected to build into key supplier documents and agreements.
The second is the shared audit program. "PSCI Audits may be initiated by PSCI members or suppliers." A supplier can also put itself forward to the PSCI Secretariat under the self-paid model.
"After the on-site audit, the audit will be documented in a standardized PSCI Audit Report Template, which includes: an overview of the audited facility, the completed questionnaire and a summary of positive and negative findings."
"The Corrective Action Plan (CAP) contains all findings and their proposed corrective actions (including timeframes for completion), agreed upon by the auditor and the supplier." The shared-audit page describes no score and no grade.
The supplier controls who sees the result: "As outlined in the PSCI Audit Guidance, the supplier may choose to share the audit documents with either all current and future PSCI members, or just with selected PSCI members." Sharing runs digitally through PSCI's web application, or through the PSCI Data Sharing Agreement.
"The audit sharing program enables suppliers to share audits with more than one member via a web application." That application sits behind a login; the audit reports themselves are not published.
Two lists on the owner's site are public: its members, and the audit firms it has approved.
Who owns it
"The PSCI was formed as a project between the six founding members in 2006 and was legally established in the United States as a non-profit membership organization in 2013."
"Our purpose is sector collaboration, using one voice to define, instil and drive responsible value chain practices."
Membership comes in two categories, Full and Associate, alongside a Supplier Partnership. On 3 September 2026 the membership page showed 86 Members Worldwide — 37 Full Members and 49 Associate Members — and named companies including Abbott, AstraZeneca, Bayer, Boehringer Ingelheim and Bristol Myers Squibb as full members, AbbVie and Amgen as associate members.
Eligibility is tied to what a company earns its revenue from: more than half of it from patented or proprietary medicines or medical devices, from own-brand direct-to-consumer sales, from generics under its own licence, or from supplying patented or proprietary components.
Who assesses it
Audits are carried out by independent third-party firms that PSCI approves and lists publicly. On 3 September 2026 that list carried 29 firms, among them BSI Group, Bureau Veritas, DEKRA, ERM, Intertek, LRQA, SGS, TÜV-Rheinland and WSP.
A firm that is not on the list applies through PSCI's New Audit Firm Application Brochure.
The five areas of the PSCI Principles
- Ethics
- Human Rights
- Health & Safety
- Environment
- Governance & Management Systems
Sources
- PSCI — Shared Audits (scheme owner) ↗ — accessed
- PSCI — About (legal form, vision, purpose) ↗ — accessed
- PSCI — Principles for Responsible Supply Chain Management ↗ — accessed
- PSCI — Audit collaboration (sharing through the web application) ↗ — accessed
- PSCI — Approved audit firms (public list) ↗ — accessed
- PSCI — Membership (categories and public member list) ↗ — accessed
Last verified:
This page is for information only; it does not accredit, certify or endorse any organisation. Requirements and programs change — always confirm against the primary source linked above.