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The highest standards of quality and safety

We believe every patient deserves, timely, high quality, safe medicines.



AbbVie knows patient and customer health relies on a culture of quality and safety. We prioritize our patients and customers and hold ourselves to the highest standards of quality and safety. This means using advanced technologies and control measures to manage and mitigate risk at every stage of drug discovery, development, manufacturing and delivery.

Our internal and external safety systems are managed to the highest standards. We work in collaboration with top academic scientists, health authorities and industry peers to ensure we not only adhere to the highest standards, but actively advance the field of pharmaceutical quality and safety.

Product quality

We have robust systems in place to ensure the medicines we manufacture are high quality and available when 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 standard organizations.  

Supply assurance

Our assurance of supply program is designed to help us maintain supply of medicines for our patients who rely on them. Even in unpredictable circumstances, such as during the COVID-19 pandemic, we ensured our patients continue to receive uninterrupted supply of medicines. This includes identifying and qualifying backup suppliers, scanning the environment for potential risks and 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.

Patient safety

Our safety team of physicians and scientists are recognized experts both within and beyond AbbVie. In collaboration with academic scientists, health authorities and industry peers, we all actively advance the field of pharmaceutical safety. Our integrated, multi-disciplinary approach and advanced technologies are designed to identify potential safety signals early and minimize risk. We continually advance the knowledge, skills and effectiveness of our safety teams, from those working on the drug development process, to those interacting with patients.

Our beliefs in action

From our clinical trials to our marketed products, our practices reflect a deep commitment to patient safety:
 

  • AbbVie was a leading adopter of the 2015 FDA Safety Assessment Committee recommendations for clinical trials, establishing an internal Safety Committee to advise and monitor two strategic clinical development programs.
  •  We comply with Good Clinical Practice, a global standard that helps assure the safety, integrity and quality of trials across trial design, implementation and outcomes reporting.
  • Our product labeling and packaging is developed with patients’ needs in mind. We conduct in-depth research to understand patient preferences and behaviors to ensure that dosage instructions are clear to prevent accidental misuse. 
  • We maintain a robust pharmacovigilance program once our medicines are approved and marketed. Our advanced post-marketing surveillance systems detect and address potential safety signals quickly.
  • Our safety experts are leading thinkers in the field of Pharmacovigilance. They edited and made major contributions to the industry-shaping book, “Pharmacovigilance: A Practical Approach.”

At AbbVie, scientific advancement doesn’t stop with our medicines. Our safety scientists are continually advancing both theory and practice in the field of patient safety. See some of their publications and learn more about our approach:

Writing the book on pharmacovigilance to advance a public health approach to patient safety.

Moving the field of safety science forward by integrating cognitive and behavioral systems, medical assessment, and data science.

Supporting evidence based best-practices for prescription drug labelling and educational materials.

98%

We routinely achieve over 98 percent on-time expedited reporting of adverse events to U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)  

For the Well-Being of Our Patients