We maintain a robust quality system with harmonized processes and procedures. These include providing integrated medical safety evaluations and benefit-risk assessments as well as monitoring the quality and safety of in-market and investigational products.
Novartis has a robust and independent audit program that covers all Novartis internal sites and functions as well as suppliers.
The Novartis Quality Management System describes how Novartis addresses external health authority regulatory requirements and other standards to ensure the highest quality in Novartis processes, products and services.
All Novartis associates are trained to help ensure a solid understanding of our patient safety and quality processes, and we are regularly audited on our training procedures.
We publish the results of our inspections by regulatory authorities, and take the necessary corrective and preventative actions to help ensure the highest quality in our operations.
Novartis maintains a comprehensive process to assess quality defects and safety issues, and publishes product recall data over the past five years.
Our third-party suppliers involved in product quality and patient safety processes are required to adhere to rigorous assessments, qualification requirements and monitoring.