Product Quality & Safety

Our transformative medicines and products only matter if they are safe, effective and accessible to everyone who needs them, when they need them.

As a global biopharmaceutical company, we have a responsibility to the patients and customers who depend on our medicines and products. That’s why we hold ourselves to high standards of quality and safety.

What we believe

Our beliefs underly our commitment to upholding the highest standards of quality every day.

We all own quality

Ensuring quality is everyone’s job so that we can deliver a consistent stream of innovative medicines and products and have a lasting impact on people’s lives.

Every voice matters

In our culture of quality, if you SEE something, SAY something, DO something.

Everyone is empowered to uphold compliance

If we focus on quality and flawless execution, compliance will follow. We empower all employees to be critical, constructive and uphold AbbVie to the highest standards of quality, every day.

AbbVie is an industry leader in quality

Our pride in product quality and commitment to patient safety are a powerful combination that motivates employees to stay vigilant, speak up and be part of the solution.

Our approach to patient safety

Our pharmacovigilance and patient safety teams identify potential safety issues and mitigate their impact on patients in order to improve the patient experience.

Over the course of 2022, at any given time, these teams were supporting approximately 250 clinical trials and approximately 200 marketed products and devices.

These teams also address any risks of our medicines being counterfeited or diverted by regularly providing education and training to employees, health care providers and law enforcement officials in higher-risk geographies.

Our approach to quality

We have robust systems in place to ensure the products we manufacture are high quality and available when customers and patients need them. Our Quality Council oversees our quality strategy and is accountable directly to our CEO. Expert teams oversee every aspect of our processes, from discovery and development through manufacturing and delivery.

In addition to internal control measures, our quality processes are reviewed, certified and audited by multiple external regulatory authorities and notified parties. We use an integrated enterprise quality management system that complies with all applicable global standards and regulations (GxP) from the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA) and other leading standards organizations.

Assurance of supply

Our assurance of supply program is designed to help us maintain supply of medicines and products. We ensure patients and customers continue to receive uninterrupted supply of the products they need, even in unpredictable circumstances, by identifying and qualifying backup suppliers, scanning the environment for potential risks and doing scenario planning.

To ensure the quality and integrity of our supply chain, we have a supply chain management system that includes criticality assessment, controls, relationship management and continuous monitoring.

AbbVie's supply chain is consistently ranked as a global supply chain leader, and in 2022, was ranked #20 in the Gartner Supply Chain Top 25.