The QMS intended to ensure that Sanofi products and services satisfy the expectations of our patients, customers, and other public health needs, in full compliance with applicable Good Practices (GxP) regulations (GCP, GDP, GLP, GCLP, GMP, GRP & GPVP¹) and other health-related requirements.

The Sanofi QMS framework and principles are fully aligned with the ICH Quality Guideline Q10 on Pharmaceutical Quality System.

The structure and key processes of our quality management system are described in the Sanofi Quality Manual, which must be applied by everyone at every level in our organization. The Sanofi Quality Manual includes the following processes:

• Product life cycle processes: research, lab trials, medical and clinical trials, manufacturing and distribution;
• Transverse processes: documentation management, improvements to products and processes, training and certification, management of third-party suppliers, information system management; and
• Organizational processes: quality systems management, quality audit, quality risk management.

Practical measures taken to implement the Sanofi Quality Management System include:

• Throughout the physical journey of Sanofi products, we strive to maintain consistent levels of quality, security, and traceability. We use technology to protect against misappropriation, counterfeiting, and falsification. At every stage of the logistics chain, Sanofi seeks to ensure products are stored, transported, and delivered under conditions that maintain product quality;
• All complaints and pharmacovigilance information reported to Sanofi are recorded, analyzed and, where relevant investigated, and trended. Appropriate corrective and preventive measures are implemented as necessary to address the situation. A recall process is in place to retrieve faulty materials from the market whenever needed;
• Quality risk management is integral to Sanofi’s quality management system, enabling us to make informed decisions and assure regulators of our crisis prevention capabilities. Our approach is both reactive and proactive. Reactively, we address quality issues swiftly with corrective and preventive measures. Proactively, we monitor internal and external indicators to identify and mitigate potential risks; and
• Sanofi is also implementing a Quality Culture program to promote the empowerment, accountability and engagement of all employees involved in regulated activities.
• Quality functions verify that all third parties maintain properly trained personnel to support manufacturing operations in compliance with applicable regulatory requirements. All on-site contractors are trained to necessary GMP and local rules and procedures. For sub-contractors and suppliers, training of employees to GMP is a mandatory section in our quality agreements approved by both parties. Adherence to these requirements is periodically assessed during audits conducted on a risk-based frequency.

Sanofi’s Global Quality policy, implemented via the QMS, is designed to support stakeholders to achieve Sanofi’s ambition to put into place a dynamic, high performing and data-driven organization and decision making. Its fundamental principles are set out in a document signed jointly by our Chief Quality Officer and our Chief Executive Officer.

This policy document is made available to all our employees in all countries; the latest version was approved in September 2025.

Sanofi operational units, sites, countries, and functions are periodically audited by an independent team to verify compliance to the Sanofi QMS. The audit frequency, duration, and number of auditors are determined using a risk-based model.

These audits also facilitate readiness of the Sanofi entities and functions for regulatory authority inspections. Any significant deviation found is subject to an action plan to fix or improve the situation.

We require all third parties to meet Sanofi's rigorous standards and comply with applicable regulations. Qualified auditors conduct regular assessments to verify compliance with established specifications, quality agreements, and industry best practices. When significant gaps are identified, we implement documented corrective and preventive action plans with defined timelines to systematically address and resolve any issues.

In addition to our own internal verification and audit procedures, for all manufacturing, supply and distribution of Sanofi pharmaceutical products, we maintain the required manufacturing licenses and GMP/GxP certificates issued by relevant health authorities (such as FDA, ANSM). These certifications, granted following regulatory inspections, confirm that our quality management systems and operations comply with applicable regulatory requirements.

At Sanofi, we empower our employees with essential skills, fostering a culture where quality is everyone's responsibility and critical thinking is embedded in every decision across the organization.

All Sanofi employees who are directly or indirectly operating within the Sanofi QMS and are engaged in the research, development, manufacturing, distribution, and discontinuation of the Sanofi products and services, are assured to have the right education, skills, training, and experience, or any combination thereof, to enable them to perform their assigned roles.

An annual GxP refresher program is in place to ensure continuous awareness of all employees involved in regulated activities and covers various topics.  These may include, but are not limited to, quality principles, risk management, deviation management, change control, document management, data integrity, quality culture, and inspection readiness. Topics are reviewed and selected each year to align with current priorities and evolving needs.

Sanofi maintains a comprehensive product recall system that enables prompt and effective retrieval of products at any level in the distribution chain when necessary. Our recall process includes thorough investigation, timely communication with health authorities, and systematic follow-up to ensure patient safety remains our highest priority.

1. Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical and Laboratory Practices (GCLP), Good Manufacturing Practice (GMP), Good Regulatory Practices (GRP), and Good Pharmacovigilance Practice (GPVP)