User account menu Search Menu Home About Quality Audit program Audit program To maintain compliance with our quality and safety standards and to support the continuous improvement of our QMS, Novartis has a robust and independent audit program that covers the product lifecycle. The audit program is governed by global procedures and covers Novartis internal sites and functions as well as suppliers. The scope of each audit depends on the type of operations conducted. The frequency of audits is based on activities performed and applicable risk assessments. The Novartis quality audit program normally conducts more than 1 500 audits per year covering internal functions, sites and external suppliers in areas including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and pharmacovigilance. Travel restrictions due to the COVID-19 pandemic had an impact on our ability to complete all the audits in our 2020 quality audit program. An annual audit plan is established to take into account audit frequency and assessed risks. Audits are performed by certified auditors. The subsequent audit report is reviewed and approved independently and distributed to the auditee (internal function, manufacturing site or external supplier) who is responsible for submitting a corrective and preventative action plan which, upon agreement, is implemented. The audit is closed when all actions in the plan have been completed. 2016 2017 2018 2019 2020 Total audits executed1 2408 2252 2147 1607 903 Internal 411 366 250 162 111 External 1997 1886 1897 1445 792 The reduction in the number of audits is primarily due to the divestment of Novartis divisions, manufacturing network and supplier consolidation, and for 2020, the impact of COVID-19. Related Links Postdoc Program Internship Programs Career Programs Managed Access Programs Novartis Navigate Patients and Caregivers Healthcare Professionals Researchers Job Seekers Journalists Investors Partners Suppliers Topics Clinical Trials COVID-19 Info Center ESG Explore Stories Diseases Locations Companies Sandoz Advanced Accelerator Applications Footer Bottom © 2021 Novartis AG Terms of Use Privacy Contacts Cookie Settings Site Map Novartis Site Directory This site is intended for a global audience Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies, select “Cookie settings” for managing the different cookies or select “Reject all” for using only strictly necessary cookies. You can change your cookie settings at any point of time by pressing the cookie settings link on the website. Cookie Settings Reject all Accept all