In global health, access without quality is not access at all. According to the World Health Organization (WHO), one in ten medical products in low- and middle-income countries is substandard or falsified, underscoring the urgency for robust quality assurance ¹. From medicines to diagnostics, when the integrity of health products is compromised, lives are at risk. At the Partnership for Supply Chain Management (PFSCM), the mission of our Quality Assurance and Regulatory (QA & R) unit is not just about compliance – it’s about ensuring the health products we deliver are safe, effective, and aligned with international standards. This commitment drives every decision we make and safeguards lives in the communities we serve, so that patients at the end of the supply chain receive care they can trust. Across the supply chain, from sourcing to delivery, there are numerous points where product integrity can be compromised. Any deviation — whether minor or critical — can have serious consequences. This applies not only to medicines, but also to medical devices, including in vitro diagnostics (IVDs).
Product integrity refers to the assurance that a health product – whether a medicine, diagnostic, or medical device — remains safe, effective, and fit for use throughout its entire journey in the supply chain. It means the product arrives at its final destination uncompromised in quality, efficacy, or safety, regardless of the operational or environmental challenges faced during storage and transport.
Why product integrity matters
That is why product integrity is non-negotiable. It is essential to protect lives. QA & R units are responsible not only for ensuring regulatory compliance but for proactively protecting patient’s health by preventing avoidable quality failures.
Managing real-world supply chain incidents
Our QA & R unit is involved in every stage — from supplier selection to incident resolution — with a single goal: to prevent avoidable harm by actively managing quality risks.
During shipments, QA & R collaborates closely with 4PL and Logistics teams, who notify QA & R promptly when an incident occurs, such as:
- A delay
- Suspected damage
- A potential temperature excursion
- Any other shipment-related issue
Timely communication is critical. The logistics team provides QA & R with all available data, including reports, photographs, and temperature monitoring records.
Once alerted, QA & R assess the urgency and scope of the incident. If required, they engage directly with suppliers and logistics partners to evaluate the risks and define appropriate next steps.
When a shipment cannot be halted in transit, the client/end user is notified, and the goods are placed under quarantine upon arrival. A full investigation is conducted, and a final decision is made based on technical and quality evidence.
PFSCM’s decisions are supported by technical product data, such as shipment stability data, product-specific stability studies, and historical shipment trends. We also incorporate supplier input and expertise in our assessments.
For temperature-sensitive products, certified and calibrated data loggers track temperature excursions. Each variation is analyzed against stability thresholds and labeled storage and shipping conditions. If the safe use cannot be ensured, the shipment is deemed unusable, and destruction is recommended.
QA & R formally requests documented proof of destruction for rejected products, keeping the supply chain secure.
Case study: cold chain failure in Benin
“When product quality fails, it’s not just a shipment lost — it’s a life put at risk.”
To prevent recurrence, the transporter was required to develop a tailored Standard Operating Procedure (SOP) covering operational activities at the pickup location. This included clarifying roles, procedures, and handling requirements. Coordination meetings were also held to align expectations and improve communication between all actors involved in the local leg of the cold chain.
This incident highlights the critical role of clear SOPs and strong coordination, especially in last-mile delivery, where vulnerabilities are highest.
Such issues are handled through PFSCM’s incident management process — commonly referred to as the complaints process — which includes root cause analysis, implementation of resolution steps, and assignment of Corrective and Preventive Actions (CAPAs).
Global standards and incident reporting
At PFSCM, maintaining the highest standards of product quality is a top priority. Our QA & R system is structured to help maintain product integrity across PFSCM-managed stages of the supply chain. Our policies and controls are intended to help ensure that products we procure, transport, and deliver remain safe and effective and retain their integrity throughout those stages
Maintaining the highest standards of product quality is a PFSCM priority. We are required to comply with quality management standards appropriate to their product category and role.
In practice, this means:we only source from suppliers who meet stringent, internationally recognized standards and global guidelines, including:
- Current Good Manufacturing Practice (cGMP) — for active pharmaceutical ingredients (APIs) and finished pharmaceutical products.
- ISO 13485:2016 — for medical devices, in vitro diagnostics (IVDs), and device accessories.
- Good Storage and Distribution Practices (GSDP) — for warehousing and distribution operations (including cold chain).
- ISO 9001:2015, and 13485:2016 — An international quality management system (QMS) standard used to assess organisational controls for non-regulated suppliers/services; it complements but does not replace – cGMP, ISO 13485:2016, or GSDP where those apply.
These quality system standards and guidelines govern how suppliers operate. Separately, the products we procure must also meet defined applicable regulatory benchmarks (see below).
All PFSCM-approved suppliers share our commitment to product integrity and compliance.
When a product does not meet expected standards, our QA & R team follows a structured process to investigate and resolve the issue. We identify root causes, implement corrective actions, and prevent future occurrences — ensuring trust and safety across the supply chain.
PFSCM’s QA & R policies are designed not only to protect patient safety but also to prevent costly and wasteful product issues, such as recalls or destruction.
We only procure applicable products from approved suppliers that comply with the following regulatory benchmarks:
- WHO-prequalified products
- Products approved by a WHO-Listed Authority (WLA)
- Products authorized by founding members of the Global Harmonization Task Force (GHTF)
- Compliance with applicable national regulatory requirements
These global standards help us ensure product safety and effectiveness at every stage.
New evidence spotlight: excipient contamination and criminal substitution
A recent synthesis of WHO and UNODC findings warns that toxic industrial chemicals can enter medicine supply chains when pharmaceutical excipients are criminally substituted – e.g., diethylene glycol (DEG) or ethylene glycol (EG) swapped in for pharmaceutical-grade glycerin, propylene glycol, or sorbitol³. Even tiny amounts can be lethal, especially for children.
Across 90 years, at least 25 documented incidents of excipient contamination have caused more than 1,300 deaths, many among children. Recent tragedies in The Gambia, Indonesia, and Uzbekistan brought renewed scrutiny, with roughly 334 deaths reported in those three outbreaks alone².
Investigators highlight systemic weaknesses that enable this harm: falsified labels and certificates, marketing of falsified excipients online, gaps in oversight of excipient manufacturers and distributors, and limited cross-border coordination and enforcement. Recommended remedies include tighter regulatory frameworks, stronger traceability, better post-market surveillance, and closer collaboration among health authorities, law enforcement, and industry.
What this means for QA in practice
- Treat high-risk excipients as critical materials with end-to-end chain-of-custody verification.
- Independently verify certificates of analysis and use approved suppliers with GMP compliant controls (e.g., supplier qualification, batch/CoA verification and identity testing, traceability, temperature-controlled storage/transport, label control, deviation/CAPA, and good documentation practices).
- Apply risk-based sampling and testing—especially for solvents/sweeteners in liquid formulations.
- Ensure escalation pathways for suspected excipient issues (quarantine, testing, recall, destruction) are clear and fast.
These steps align with PFSCM’s data-driven approach – audits, trend analysis, and real-time in-transit risk assessment – to anticipate and neutralize risks before they reach patients.
Mitigating risk and protecting lives through quality
At PFSCM, our QA & R unit brings deep technical expertise and commitment to every product we procure. By leveraging historical data, supplier audits, and trend analysis, we anticipate risks before they escalate. This data-driven approach supports faster decision-making and better health outcomes, embedding quality into every link of the supply chain.
From rigorous supplier oversight to real-time in-transit risk assessment, our QA & R unit ensures that products arrive safely, effectively, and therefore fit for purpose.
Our work goes beyond systems and standards – it is about the people who depend on these products for well-being, recovery, and survival. Every protocol we follow, every decision we make, is guided by our responsibility to them.
Because in global health, quality isn’t optional – it’s lifesaving. And at PFSCM, we deliver nothing less.
Footnotes
1 World Health Organization. Substandard and falsified medical products (Fact sheet). 3 December 2024.
https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
2 Inter Press Service (IPS). Malawista M. Global Supply Chain Failures are Causing Pharmaceutical Contamination. 7 August 2025. https://www.ipsnews.net/2025/08/global-supply-chain-failures-are-causing-pharmaceutical-contamination/
3 World Health Organization & United Nations Office on Drugs and Crime. WHO and UNODC release landmark report on contaminated medicines, urging action to protect patients from preventable harm. 24 July 2025. https://www.who.int/news/item/24-07-2025-who-and-unodc-release-landmark-report-on-contaminated-medicines–urging-action-to-protect-patients-from-preventable-harm
