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UNICEF to lead procurement and supply of COVID-19 vaccines in world’s largest and fastest ever operation of its kind

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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UNICEF is leading efforts to procure and supply COVID-19 vaccines in what could possibly be the world’s largest and fastest ever procurement and supply of vaccines, as part of the global vaccine plan of the COVID-19 Vaccine Global Access Facility (COVAX Facility) led by Gavi, the Vaccine Alliance.

With several vaccine candidates showing promise, UNICEF, in collaboration with the PAHO Revolving Fund, will lead efforts to procure and supply doses of COVID-19 vaccines on behalf of the COVAX Facility for 92 low- and lower middle-income countries whose vaccine purchases will be supported by the mechanism through the Gavi COVAX AMC as well as a buffer stockpile for humanitarian emergencies. In addition, UNICEF will also serve as procurement coordinator to support procurement by 80 higher-income economies, which have expressed their intent to participate in the COVAX Facility and would finance the vaccines from their own public finance budgets.

UNICEF will undertake these efforts in close collaboration with WHO, Gavi, CEPI, PAHO, World Bank, the Bill and Melinda Gates Foundation and other partners. The COVAX Facility is open to all countries to ensure that no country is left without access to a future COVID-19 vaccine.

“This is an all-hands on deck partnership between governments, manufacturers and multilateral partners to continue the high-stakes fight against the COVID-19 pandemic,” said Henrietta Fore, UNICEF Executive Director. “In our collective pursuit of a vaccine, UNICEF is leveraging its unique strengths in vaccine supply to make sure that all countries have safe, fast and equitable access to the initial doses when they are available.”

UNICEF is the largest single vaccine buyer in the world, procuring more than 2 billion doses of vaccines annually for routine immunization and outbreak response on behalf of nearly 100 countries. It is the main procurement partner of Gavi, the Vaccine Alliance, which over the last 20 years has reached more than 760 million children with life-saving vaccines, preventing more than 13 million deaths. UNICEF will use its market shaping and procurement expertise to coordinate the procurement and supply of COVID-19 vaccines for the COVAX Facility. This could potentially double the agency’s overall vaccine procurement throughput volume in 2021 alone.

In response to an expression of interest that UNICEF issued in June on behalf of the COVAX Facility, 28 manufacturers with production facilities in 10 countries shared their annual production plans for COVID-19 vaccines through 2023. According to the timelines the manufacturers indicated, the span from development to production could be one of the fastest scientific and manufacturing leaps in history.

A UNICEF market assessment, developed by compiling information submitted by vaccine manufacturers along with publicly available data, revealed that manufacturers are willing to collectively produce unprecedented quantities of vaccines over the coming 1-2 years. However, manufacturers signaled that investments to support such large-scale production of doses would be highly dependent on, among other things, whether clinical trials are successful, advance purchase agreements are put in place, funding is confirmed, and regulatory and registration pathways are streamlined.

This assessment also illustrates, among other things, manufacturers’ responsiveness to the COVAX Facility’s design and objectives—a key pillar of the ACT-Accelerator initiative, which is a new, groundbreaking global collaboration to accelerate the development and equitable distribution of vaccines, diagnostics and therapeutics to address the COVID-19 pandemic across countries of all income levels.

A key next step will be ensuring self-financing economies sign up for the COVAX Facility by 18 September, which will allow COVAX to support early, at-risk investments in increasing manufacturing capacity on a broad scale, through advance purchase agreements.

Currently under development by WHO, the COVAX allocation framework will guide how and where UNICEF, PAHO and other procurers working on behalf of participating countries supply COVID-19 vaccines that are secured by the Facility. Initial dose allocations are expected to be scaled to enable countries to vaccinate health and social workers, followed by subsequent tranches of vaccine doses that would enable participating countries to vaccinate populations at higher risk of critical COVID-19 disease.

“UNICEF has been critical partner in the Alliance’s success over the last two decades – helping us reach more than half the world’s population with life-saving vaccines,” said Dr. Seth Berkley, CEO of Gavi. “This expertise and experience will be important in ensuring that COVAX – as a global effort to procure and deliver safe and effective COVID-19 vaccines, on an accelerated timeframe, and at an unprecedented scale – can protect the most at-risk, wherever they may be in the world. Together we can work to end the acute stage of this pandemic, including its devastating impact on individuals, communities, and economies.”

UNICEF, Gavi, WHO, and PAHO have started critical preparatory work for country vaccine readiness in collaboration with partners and national governments including:

  • Working with device manufacturers to plan availability of safe injection equipment and cold chain requirements for the vaccine;
  • Developing guidance with WHO and trainings to support vaccination policies and appropriate handling, store and distribution of the vaccines;
  • Working with manufacturers on freight and logistics solutions to get vaccine doses to countries as quickly and safely as possible once they are allocated;
  • Supporting countries in planning for vaccine delivery, including targeting those most at risk and transport and storage at point of service delivery;
  • Ramping up efforts with civil society and other local partners to ensure that people are well-informed about the COVID-19 vaccination process and putting measures in place to enhance trust and tackle misinformation about COVID-19 vaccines.

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. 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How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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