Product Quality and Patient Safety

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.

Additionally, the QualiPSO database, launched in 2022, is fully operational across all sites and entities since April 2024, with 80,000 users worldwide. It tracks KPIs in real time, accessible at all organizational levels, enabling performance monitoring, root cause analysis, and corrective actions. The tool has streamlined KPIs from 257 to 56, offering a single dashboard with standardized calculations sourced from the QMS system.

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 2022.

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. Sanofi's audit approach and system are accredited to ISO/IEC 17020:2012.

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.

In 2024, 166 internal quality audits have been conducted (including audits of Sanofi entities and third-party audits).

In addition to our own internal verification and audit procedures, our sites are also subject to regular inspections by local authorities, or to regulatory inspections by third parties on specific issues. For example:

• 253 regulatory inspections, of which:
  • 56 European inspections
  • 32 US FDA inspections
  • 1 regulatory action taken as a result²
• 7 mandatory recalls, of which one was Class 1 recalls³

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. The topics covered by the program include quality principles, risk management, deviation management, change control, document management, data integrity, and inspection readiness.

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)

2. such as US FDA Warning Letter, US FDA Consent Decree, suspension/withdrawal of GMP certificate

3. Definition as per EMA SOP/INSP/2018 and US 21CFR part 7. Class 1 recalls can be part of mandatory or voluntary recalls.