Building Safer, More Responsible Pharmaceutical Supply Chains: PSCI Global Audit Insights

The Pharmaceutical Supply Chain Initiative (PSCI) has released its seventh annual Audit Findings Analysis Report, offering unprecedented insights into supplier practices across the global pharmaceutical and healthcare industry.With a record-breaking 243 audits analysed and over 2,596 findings documented, this comprehensive report represents the most extensive review of supply chain responsibility to date.

Record Participation Drives Industry Transparency

In 2025, PSCI Members achieved a significant milestone by uploading more audits than ever before to the collaborative platform. This collective effort—representing thousands of hours of dedicated on-site work—demonstrates the pharmaceutical industry's unwavering commitment to transparency and continuous improvement. By sharing audit results with supplier permission, Members are creating efficiencies whilst driving meaningful progress across five critical principles: Governance & Management Systems, Ethics, Human Rights, Environment, and Health & Safety.

Key Findings at a Glance

Health & Safety Remains the Primary Focus

Health & Safety continues to dominate the findings landscape, accounting for 58% of all issues identified. The most prevalent concerns include:

• Worker Protection (27%): Gaps in electrical safety programmes, inadequate LOTO (Lock-Out/Tag-Out) procedures, and insufficient pallet racking maintenance
• Occupational Health & Industrial Hygiene (26%): Missing substance-specific exposure assessments and inadequate respiratory protection programmes
• Emergency Preparedness (18%): Overdue emergency drills, inaccessible emergency exits, and incomplete fire suppression systems

Environmental Concerns Nearly Double

Environmental findings surged from 221 in 2024 to 435 in 2025, representing 17% of total findings. This significant increase reflects heightened auditor focus on:

• Hazardous waste management and documentation
• API (Active Pharmaceutical Ingredient) discharge risk assessments
• Wastewater treatment compliance
• Secondary containment and spill prevention measures

Labour Practices Demand Urgent Attention

Whilst Human Rights findings decreased to 9% of the total, their severity tells a compelling story. 81% of findings related to Wage, Benefits, & Working Hours were classified as Major, making this the subtopic with the highest proportion of serious issues. Common violations include:

• Excessive overtime and insufficient rest days
• Wages below local minimum requirements
• Inadequate social security calculations
• Contract workers paying for their own PPE

Regional Insights Reveal Distinct Patterns
India Leads in Audit Volume

India recorded the most significant increase, with 69 audits generating 1,087 findings—representing 42% of all audits analysed. Priority areas include establishing OELs (Occupational Exposure Limits) for APIs, improving fire detection systems, and implementing compliant LOTO procedures.

China Focuses on Exposure Assessments

With 37 audits yielding 330 findings, Chinese suppliers must prioritise API-specific exposure risk assessments, overtime monitoring, and emergency exit accessibility.

United States Emphasises Infrastructure Safety

Across 19 audits in the United States, findings concentrated on pallet racking maintenance, electrical safety programmes, and emergency preparedness protocols.

Western Europe Addresses Process Safety

The 79 audits conducted in Western Europe highlighted needs for improved rack securing, comprehensive exposure risk assessments, and enhanced ATEX (explosive atmosphere) studies.

Translating Findings into Action

The true value of this analysis lies not merely in identifying gaps, but in driving targeted improvements. PSCI translates these findings into:

• Interactive e-learning courses with quizzes to reinforce learning outcomes
• Biweekly webinars providing direct access to subject matter experts
• Annual supplier conferences in India and China for peer learning
• Technical workshops enabling expert-led training
• Practical tools and resources tailored to supplier maturity levels

The training curriculum is structured across four maturity levels, helping suppliers navigate resources and effectively close audit findings.

Critical Findings Demand Immediate Response

Whilst Critical findings remain relatively rare (only 5 recorded in 2025), they highlight life-threatening risks requiring immediate action:

• Missing centrifuge safety interlocks
• Compressed air used as breathing air
• Locked or inward-opening emergency exits
• Unauthorised hazardous material storage
• Missing wastewater discharge permits

The Path Forward

As Birgit Skuballa, Director ESG Governance at Bayer and Audit Committee co-lead, notes: "Every finding tells us something important about where suppliers are making progress and where more support is needed. By sharing insights, identifying common challenges, and providing support through conferences, webinars, training materials, and practical tools, we can move beyond individual findings and drive broader, more consistent improvement across global pharmaceutical supply chains."

Download the Full Report

This summary merely scratches the surface of the comprehensive insights available in the complete PSCI Audit Findings Analysis 2025. The full report includes:

• Detailed breakdowns of all five PSCI Principles
• In-depth regional analyses covering eight global regions
• Illustrative examples from actual audit observations
• Practical action plans for suppliers
• Analysis of audit methodology impacts
• Supplier category influences on findings

Access the complete report to:

• Benchmark your organisation's performance against industry standards
• Identify priority areas for capability building
• Develop targeted improvement strategies
• Understand regional compliance patterns
• Access practical guidance for closing audit findings

The pharmaceutical and healthcare industry's commitment to responsible supply chains has never been stronger. With record participation and unprecedented transparency, the 2025 findings provide a roadmap for building safer, more ethical, and environmentally responsible operations worldwide.