1. Introduction to the Global Quality Manual

1.1 Purpose

The purpose of this Global Quality Manual (QM) is to describe the framework and principles of the
Sanofi Quality Management System (QMS) and is fully aligned with the ICH Q10 Pharmaceutical
Quality System (PQS).
The Sanofi QMS is 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
regulations (GCP, GDP, GLP, GMP & GVP) and other health-related requirements.

1.2 Scope

This Global QM applies to all activities related to the research, discovery, development,
manufacturing, distribution and discontinuation of Sanofi products and services, regardless of
where these activities take place.

1.3 Sanofi at a Glance

Sanofi is a global life sciences company committed to improve access to healthcare and supporting
the people we serve throughout the continuum of care. From prevention to treatment, Sanofi
transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases,
multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular
solutions, and consumer healthcare.
More than 100,000 people at Sanofi are dedicated to make a difference on patients’ daily life,
wherever they live and enable them to enjoy a healthier life.


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