Ethics, Safety and Quality

We are committed to conducting our research and business with the highest standards of ethics, and to delivering medicines reliably, with the quality and safety patients can trust.

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Ethics & Compliance

Our employees adhere to applicable laws and regulations, as well as conduct consistent with our commitment to honesty, fairness and integrity. Read more about our Ethics & Compliance programme here.

Policies & Disclosures

AbbVie is committed to being fully transparent and compliant with our policies and disclosures. Discover our Policies here.

Providing the Highest Quality Products for Patients

Every year, tens of thousands of patients worldwide participate in clinical trials of potential AbbVie medicines. It’s because of these participants that we are able to eventually bring new medications to more patients.

  • 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. Learn more about how we are evolving our packaging for our patients.
  • We use advanced post-marketing surveillance systems to detect and address potential safety signals quickly.

Teaching tools
AbbVie safety experts edited and made major contributions to the book “Pharmacovigilance: A Practical Approach,” which focuses on principles and practice of pharmacovigilance.
 

Process improvement

Our teams are using technology to increase both efficiency and accuracy in pharmacovigilance. “Ditto” is a robot that automates the cumbersome process of checking for duplicate adverse events. Ditto allows us to increase efficiency and accuracy, and deploy valuable human resources for more complex pharmacovigilance tasks.

Product quality

We are focused on making medicines that are of high quality and available when patients need them.

The Quality Council oversees our quality strategy and is directly accountable to our CEO. Highly skilled and experienced teams oversee every aspect of our manufacturing processes, from the suppliers who provide the inputs to the medicines that are delivered to pharmacies.

Standards organizations
We use an integrated enterprise quality management system that complies with applicable standards from the International Organization for Standardization (ISO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Regulatory authorities
AbbVie manufacturing sites receive dozens of internal audits and outside inspections each year.

  • This includes identifying and qualifying backup suppliers, scanning the environment for potential risks, and scenario planning.
  • After Hurricane Maria devastated Puerto Rico in 2017, a high level of preparedness allowed us to maintain production at all three of our local plants with no impact to patients.