GLOBAL QUALITY

Quality Manual
Version 8.0
February 2022
 Quality Manual V8.0

Abbreviations and Acronyms

CHC Consumer HealthCare

CMC Chemistry, Manufacturing and Control

GBU Global Business Unit

GCP Good Clinical Practices

GDP Good Distribution Practices

GLP Good Laboratory Practices

GCLP Good clinical and Laboratory Practices

GMP Good Manufacturing Practices

GQA Global Quality Audit

GVP Good Pharmacovigilance Practices

GxP Combined term for GCP, GDP, GCLP, GLP, GMP, GRP, GVP

IA Industrial Affairs

ICH International Council on Harmonization

ICH Q10 An ICH guideline describing the modern quality systems needed to establish
and maintain a state of control that can ensure the realization of a quality
drug product and facilitate continuous improvement over its lifecycle.

OTC Over The Counter

QMS Quality Management System

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 Foreword

I am pleased to share with you this 8th edition of our Global Quality Manual.

This edition reflects the most recent changes to the Quality organization aligned with
our Sanofi “Play to Win” strategy. Global Quality is aligned and supports the
Commercial Operational Units organizations, Global Functions, Country
organizations, Industrial GBUs, as well as the Sanofi’s culture and the “Play to win”
behaviors.

Our Quality Management System was implemented in 2009 and is based upon our
strong commitment to improve the life of our patients and the public health needs
that we are privileged to serve. It is One Quality System applied to ensure the
Quality of all the Sanofi products and services throughout their lifecycle from
research and development to manufacturing, distribution and discontinuation for
established and innovative products. It is operated in a flexible and adaptable
model to include quality standards specific to each profile class of the Sanofi
product portfolio. It is constantly evolving to ensure continuous improvement and
anticipate regulatory developments and to support the needs of our Global
Business Units and Global Functions. The electronic tools supporting our Quality
Management System are also evolving to leverage the newest technologies. This
digital transformation program is meant to strengthen our capabilities to
continuously improve our systems and processes.

In line with our Company objectives of focusing on growth, leading with innovation,
accelerating efficiency and reinventing the way we work, the Quality Manual provides
to all Sanofi personnel as well as to external partners and regulators a concise and
useful overview of our Quality System structure and related key processes. It
elaborates on the fundamentals delineated in our revised Global Quality Policy
approved in February 2022. The Policy and Manual constitute the hallmarks of our
Quality Documentation pyramid, and serve as vectors
to ensure a full deployment of our Quality
management principles across the organization. They
are an important part of our desired Quality Culture
focused on patient centricity and contribute to our
innovation and continuous improvement strategic goals.

I am convinced that, thanks to the commitment to this

Quality Manual of each individual at all levels of
Sanofi, we will be chasing the miracles of science to
improve people’s lives.

3
Philippe Germanaud
Chief Quality Officer
Quality Manual V8.0

Table of Contents

1. Introduction to the Global Quality Manual .......... 6

1.1 Purpose .......................................................................................... 6
1.2 Scope ............................................................................................ 6
1.3 Sanofi at a Glance ............................................................................ 6
1.4 Our Business Strategy ...................................................................... 6
1.5 Our Products and Services ................................................................. 6
1.6 Our Behaviors ................................................................................. 7
1.7 Sanofi Organization and Activities ....................................................... 8

2. Sanofi Quality Policy .......................................... 9

3. Quality Organization and Responsibilities ........ 10

3.1 Organization Chart .......................................................................... 10
3.2 Sanofi Chief Quality Officer ............................................................... 10
3.3 Global Quality Functions ................................................................... 11
3.4 Operational Quality Units.................................................................. 12
3.5 Site Quality Management ................................................................. 12
3.6 Country Quality Management ............................................................ 13
3.7 Senior Management ........................................................................ 13
3.8 Process and Systems Owners ............................................................ 13
3. 9 Responsibilities for Third Parties (Services Providers, Suppliers and
Subcontractors) .............................................................................. 14
3.10 Responsibilities for Supply Chain ....................................................... 14
3.11 Responsibilities for Computerized Systems .......................................... 14
3.12 Responsibilities for Personnel Qualification and Training ........................ 15
3.13 Responsibilities for Quality Documentation .......................................... 15

4. Management Responsibilities ........................... 16

4.1 Planning ........................................................................................ 16
4.2 Organizing ..................................................................................... 16
4.3 Communicating .............................................................................. 16
4.4 Measuring ...................................................................................... 16
 4.5 Reviewing ...................................................................................... 17
4.6 Improving ...................................................................................... 17
4.7 Other Areas of Management Responsibilities ........................................ 17
4.7.1 Management of Change in Product Ownership .............................. 17
4.7.2 Monitoring of Internal and External Factors impacting the
Quality Management System ...................................................... 17

5. Enablers ........................................................... 19
5.1 Quality Risk Management ................................................................. 19
5.2 Knowledge Management .................................................................. 19
5.3 Quality Culture ............................................................................... 19
5.4 Data integrity ................................................................................. 19

6. Sanofi Global Quality Documentation System .. 20

6.1 Quality Processes ............................................................................ 20
6.1.1 Product Life-Cycle Processes ..................................................... 20
6.1.2 Transversal Processes .............................................................. 24
6.1.3 Organizational Processes .......................................................... 25
6.2 Documentation Hierarchy ................................................................. 26
6.3 Quality Documents Type .................................................................. 27

7. Global Quality Audits and Regulatory

Inspection…………………………………………….....28

8. Document Approvals ........................................ 30

9. Document History ............................................. 31

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 Quality Manual V8.0

1 Introduction to the Global Quality Manual

1.1 Purpose
The purpose of this Global Quality Manual is to describe the framework and principles of
the Sanofi Quality Management System (QMS). It is fully aligned with the ICH Q10
Pharmaceutical Quality System.

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, GCLP, GMP, GRP & GVP) and other health-
related requirements.

1.2 Scope
This Global Quality Manual applies to all activities related to the research, development,
manufacturing, distribution and discontinuation of Sanofi products and services as well
as to medical and commercial activities, 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, cardiovascular, and consumer healthcare.

Approximatively 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.

1.4 Our Business Strategy

The Sanofi business strategy, Play to Win, is built upon four key priorities:
• Focus on Growth: Portfolio prioritization to strengthen profile
• Lead with Innovation: Bring transformative therapies to patients
• Accelerate Efficiency: Decisive actions to expand margins
• Reinvent How We Work: Empowerment and accountability

1.5 Our Products and Services

Sanofi manufactures a diverse profile class of products and services, categorized as:

• Drug substances (Active Pharmaceutical Ingredients)

• Cosmetics

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 • Investigational medicinal products
• Medical devices, including digital solutions, and combination products
• Medicinal products (including OTC products)
• Nutraceuticals
• Vaccines

1.6 Our Behaviors

Sanofi Play to Win strategy is supported by four behaviors:

#1 Stretch to go
#2 Take action
beyond the level we
instead of waiting to
have operated at up
be told what to do
until now

#4 Think Sanofi
#3 Act in the first I put the
interest of our interest of the
patients and organisation
customers ahead of my own or
those of our team

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1.7 Sanofi Organization and Activities

The Sanofi Company is organized in:

• Four Global Business Units (GBUs) integrating global franchises, country level
commercial and medical organizations for each of our major businesses:

o Specialty Care - Dupixent and specialty production (Rare Diseases,

Multiple Sclerosis, Oncology & Immunology)
o General Medicine (Insulins, Clexane and new product launch)
o Vaccines
o Consumer Healthcare
• Various Global Functions

o Business transformation
o Corporate Affairs
o Finance
o Digital
o Global Business Services
o Global Industrial Affairs
o Global Research & Development
o Human Resources
o Internal Audit & Risk Management
o Legal, Business Integrity & Ethics
o Strategy & Business Development.

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2 Sanofi Quality Policy

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3 Quality Organization and

Responsibilities

3.1 Organization Chart

Chief Executive
Global IA Head
Officer

Chief Quality
Officer

Admin & Support

Vaccines
Quality
Operations
Global Quality Audit Quality Management CHC IA
and External Systems & Digital Platform
Liaison Transformation Quality
Operations
Digital
Quality
Operations

Supply Chain,
Specialty Global Medical,
General Procurement
R&D Sites Med Devices Care IA Clinical and
Medicine IA & Global
Quality Quality GBU Country
GBU Quality External Mfg.
Operations Operations Quality Quality
Operations Quality
Operations Operations
Operations

Operation in dotted line to the CQO Function in solid line to the CQO Operation solid line to the CQO

3.2 Sanofi Chief Quality Officer

The Sanofi Chief Quality Officer is directly responsible to the Chief Executive Officer for
defining the Sanofi Quality Policy, coordinating its implementation across the relevant
Sanofi entities and ensuring compliance with the related regulatory and Company
requirements. The Sanofi Chief Quality Officer is the representative of the Sanofi Senior
Management for quality related matters.

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In addition, the Sanofi Chief Quality Officer, reports operationally to the Executive Vice
President of Global Industrial Affairs, and is a core team member of the Sanofi Global
Industrial Affairs Leadership Team, the Sanofi Global Risk Committee and the Sanofi
Global Compliance Committee.

3.3 Global Quality Functions

Two Global Quality Functions directly report to the Sanofi Chief Quality Officer:

Global Quality Management System & Digital Transformation

The mission of the Quality Management System and Digital Transformation group is to
drive the Sanofi Quality System & Strategy built upon the strategic orientations of the
Company and the international health-related regulations, using digitalization as an
enabler, to assure patient safety.

This mission is achieved through the following Global Quality functional areas reporting
to the Head of GQ SC&T:

• Quality Programs
• Digital transformation
• Qualified Persons Responsibilities & Industrial CMC Compliance
• Quality Alert Management including Product recall, Quality Alerts, Product Alerts
of quality origin, and Product Shortage reporting
• Quality Risk Management
• Quality Academy and Training
• Quality Documentation
• Strategy, Culture & Performance
• QC Excellence
• Experts’ group

Global Quality Audit and External liaison

The mission of Global Quality Audit and External Liaison is to:

• Provide Senior Management accurate, independent assessments of compliance to

the Sanofi Quality Management System through regular surveillance audits of
Sanofi entities and key third parties.
• Support Pre-Approval Management Group (PMG) activities and entity regulatory
inspections.

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• Lead the Quality external strategy and influence external pharmaceutical

industry associations and regulatory agencies to advocate and promote the
Sanofi Global Quality “One-Voice” strategy.

• Perform quality assessments in support of due diligence.

• Deliver auditor qualification and technical training.

3.4 Operational Quality Units

Nine Operational Quality Units report to the Sanofi Chief Quality Officer.
The mission of the Heads of the Operational Quality Units is to lead and coordinate
quality and compliance in their Operational Units to ensure that all products and services
are designed, developed, manufactured and distributed in compliance with the
applicable regulatory and Company requirements.
This includes the following responsibilities, as a minimum:
• Accountable for GxP compliance and quality performance for products and
services in the GBUs
• Ensure and harmonize consistent implementation of the Sanofi QMS in their
Operational Unit
• Ensure continuous improvement of the quality concepts, promote innovation and
systems performance in their Operational Unit
• Provide support to the local entities of their Operational Unit on quality and
compliance topics
• Integrate risk management principles into Quality Systems
• Review and approve quality organizations of their Operational Unit
• Assess performance of Quality Management in conjunction with Operational
Management
• Ensure inspection readiness and strictly follow-up to GxP regulatory inspections
The Heads of the Operational Quality Units report operationally to the Chief Quality
Officer, except for the Head of the Operational Quality Unit in charge of Vaccines GBU,
the head of CHC Quality Operations and the head of Digital Quality Operations who
report functionally to the Sanofi Chief Quality Officer. The head of R&D SQO reports also
functionally to the R&D operations Head.

3.5 Site Quality Management

At each Site involved in research & development, manufacturing and distribution
activities, a Site Quality Head or Manager is appointed to define, implement, manage and
control the Quality Systems at the Site, in order to ensure the quality of products and
services, and to guarantee compliance with applicable regulatory requirements and the

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Sanofi Quality Management System.
For IA, the SQM reports to the Head of the Operational Quality Unit and to the Senior
Site Director or General Manager. For R&D, the SQM reports to the R&D Operations
Units head.

3.6 Country Quality Management

At each Country Commercial office within Sanofi, a Country Quality Head is appointed
to define, implement, manage and control the Country Quality System, in order to
ensure the quality of products and services at market level and to guarantee compliance
with applicable regulatory requirements and the Sanofi Quality Management System.
The Country Quality Head reports to the Regional Quality Head and to the Country Lead.
In countries where local regulations require a Responsible / Qualified Person, the
Country Quality Head is the qualified person, or delegates this responsibility to a
designated person.

3.7 Senior Management

Senior management is a team of individuals at the highest level of authority in their
respective organization who have the day-to-day task to manage that organization.
Senior Management at Operational Unit, Site and Country level has the ultimate
responsibility for the overall effectiveness of the QMS. Senior Management ensures that
roles, responsibilities and authorities related to the QMS are defined, communicated and
implemented throughout the Sanofi Company.
In practice, Senior Management:
• Participates in the design, implementation, monitoring and maintenance of the
QMS throughout their organization
• Demonstrates strong and visible commitment to the QMS
• Ensures a timely and effective communication and escalation process exists to
raise quality issues to the appropriate levels of management
• Conducts management reviews of process performance, product quality and the
QMS effectiveness
• Advocates continuous improvement
• Determines and provides adequate and appropriate resources to implement,
maintain and continuously improve the QMS.

3.8 Process and Systems Owners

Process owners are accountable for the end-to-end process and from the standard and
process design to its performance measurement. The process owners ensure the GxP
compliance of the process and its continuous improvement and establish the quality
standard and training requirements related to the system.
System owners are accountable for the alignment of the computerized solution with the
process and strategy defined by the process owner and ensure the GxP compliance of

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the computerized solution and associated data.

3.9 Responsibilities for Third Parties (Services Providers,

Suppliers and Subcontractors)
Development (including clinical and/or laboratory study activities), manufacturing and
distribution of Sanofi products, as well as GxP related services and medical and
commercial activities, may be with an alliance partner or subcontracted to third parties,
under the responsibility of an Operational Unit, Site, External Manufacturing or Country.
The acceptability of these partners (and their third parties) and our third parties (service
providers, suppliers and subcontractors) is verified through a formal process including
initial assessment (including due Diligence), qualification and routine evaluation of their
compliance with applicable regulatory requirements and the Sanofi QMS.
In addition, GxP related materials, equipment and services are purchased from approved
or certified suppliers using pre-defined acceptance criteria, including compliance with
technical specifications and quality requirements.
The quality oversight of partners and all third parties is under the responsibility of the
relevant Operational Quality Unit, Site Quality Management, External Manufacturing
Quality or Country Quality Management.

3.10 Responsibilities for Supply Chain

Operational Units, Sites, External Manufacturing, and Countries are responsible for
maintaining the quality, security and traceability of all Sanofi materials and products
throughout their physical flows. This includes the implementation of appropriated
technologies to protect the materials and products against diversion, counterfeit and
falsification.
Throughout the entire Supply Chain, appropriate conditions of storage, transport and
delivery of materials and products ensure that the quality attributes of materials and
products are maintained in compliance with applicable regulatory and Sanofi QMS
requirements.

3.11 Responsibilities for Computerized Systems

Computerized systems in support of development (including laboratory studies and
clinical trials), manufacturing, distribution, medical and commercial activities, and the
electronic data they contain, are subject to specific regulatory requirements.
Computerized systems which are part of the products and services, such as software
embedded in medical devices, are also subject to such requirements.

These requirements apply during the whole system lifecycle including design,
development, validation, use, support, maintenance and decommissioning.

The Digital Quality Operation Unit ensures that computerized systems are built,
supported and maintained in compliance with applicable regulations and expected
business performance (including data integrity) during their entire lifecycle.

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Global Quality, Operational Quality Units, Site Quality Management and Country Quality
Management ensure that computerized systems fit for their intended use and comply
with applicable regulations and expected performance, so the business process and system
does not adversely impact the product quality, patient and consumer safety and related
data integrity.

3.12 Responsibilities for Personnel Qualification and

Training
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.

Training in the applicable regulations and Sanofi QMS is mandatory for all Sanofi
employees and is regularly conducted within their functional areas and with sufficient
frequency to assure that employees remain familiar with the applicable requirements
and processes.

The Quality Academy is an important enabler of Personal Qualification and Training as it

provides training resources and fosters continuous learning and education to our people.
Together with representatives of global functions and operational platform units, the
Quality Academy governance prioritizes and rationalizes training related to Quality
competencies.

3.13 Responsibilities for Quality Documentation

The Site, platform and Country Quality Management are responsible to ensure the roll-
out and the enforcement of the requirements of the Sanofi Global Quality Documentation
System at local level. Consistency and continuity between both systems are critical.

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4 Management Responsibilities

Senior management has the responsibility to demonstrate strong and visible

commitment to the Sanofi QMS by taking accountability and responsibilities for these
activities. The participation and commitment of all personnel to the Sanofi QMS is
effectively achieved through senior management leadership and action.

Senior management and their teams are responsible for implementing and maintaining
the Sanofi QMS within their respective Operational Unit, Site or Country. Therefore,
management must commit to the principles described below.

4.1 Planning
Senior management fully integrates quality into the organization’s strategic and
operational planning and business processes.

The Global Quality Senior Leadership Team establishes a companywide vision as a basis
for the Quality strategy, goals and objectives and cascades them down throughout the
organization with the purpose to involve personnel at all levels of the Company in quality
improvement. Quality objectives are aligned with the Company’s strategy and are
consistent with the Quality Policy.

4.2 Organizing
Senior management provides the required capital and human resources to guarantee
complete and timely delivery of the strategic and operational plans, and to implement,
maintain and continuously improve the QMS. This includes sufficient personnel with the
necessary competencies to fulfil their roles and responsibilities, appropriate facilities and
equipment and ways of working operating effectively across the entire Sanofi Company.

4.3 Communicating
Senior management provides effective communication and related communication
processes to promote the Quality Policy and Quality objectives to increase awareness,
engagement and involvement of everyone in Sanofi.

The Sanofi Quality Alert process ensures a timely and effective communication and
escalation of product quality and quality system issues to the appropriate levels of
management.

4.4 Measuring
Senior management has a performance measurement and reporting system for quality
results, quality issues and progress against quality objectives. Measures are used to

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identify areas for continuous improvements.

4.5 Reviewing
Senior management has quality performance metrics reviewed as a key requirement in
relevant senior management meetings.

As Quality Governance, progress against the strategic and operational plans is evaluated
regularly and the overall process performance, product quality and effectiveness of the
QMS is reviewed actively. These reviews are intended to identify areas for continuous
improvement.

4.6 Improving
Senior management sets continuous quality improvement as an objective throughout
Sanofi.

4.7 Other Areas of Management Responsibilities

4.7.1 Management of Change in Product Ownership
Management takes responsibility for the integration of a new entity into the Sanofi
Company and the Sanofi Quality Management System in accordance with the selected
integration model.

4.7.2 Monitoring of Internal and External Factors impacting the Quality

Management System
Management monitors internal and external factors with a potential to impact the Sanofi
Quality Management System. Monitored factors are:

• Emerging regulations and guidance

• Quality issues that can impact the Quality Management System
• Innovations that may enhance the Quality Management System
• Changes in the business environment and business objectives.

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5 Enablers
5.1 Quality Risk Management
Quality risk management is an integral part of the Sanofi system of control and
governance.

A systematic risk management process provides a proactive means to identify, assess,

remediate, mitigate, escalate, monitor, review and communicate potential quality risks
applicable to products and services, processes, systems and projects, Operational Units,
Sites and Countries. This includes review and escalation of both proactive and reactive
risks at local and global levels which incorporate the review of risks.

Quality risk management facilitates continuous improvement of process performance

and product & services quality. Mechanisms, including the establishment of a Site Risk
Profile and the escalation of quality alerts, are means to identify, track and trend risks
throughout the product lifecycle.

A Quality Risk Representative is designated by the Operational Quality Units to lead and
provide oversight of the quality risk management of their unit. This is achieved in
accordance with the requirements set in the Global Quality Risk Management
documentation.

At a global level, quality risks are further consolidated, ranked and managed following
the Global Quality Risk Profile process.

5.2 Knowledge Management

There are several systematic processes within Sanofi that are designed to formally
acquire, analyze, store, and disseminate product and process knowledge throughout the
product lifecycle.

These processes, which are explained within our Global Quality Documents, help to
ensure effective product development, scale up, technology transfer, process validation,
continual improvement and post-approval change management that meet all the
applicable regulatory and company requirements.

5.3 Quality Culture

Quality culture is the mindset and behavior to consistently perform the right things in
the design and execution of the quality management principles right first time. Il applies
to people from all entities, GBU and businesses in Sanofi. Within Sanofi the quality
culture is critical for the successful execution of our business performance and strategy.
In this context, Global Quality has defined the quality culture as “an environment where
employees can hear, see, and feel quality all around them”.

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5.4 Data integrity
Data integrity is paramount to support the quality, safety and efficacy claims of our
products. Global Quality is therefore engaged in fostering data integrity assurance at all
levels of the company through implementation of our quality standards during data
lifecycle. A dedicated training program is also in place to reinforce this critical concept
to all employees handling GxP data.

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6 Sanofi Global Quality

Documentation System

Sanofi Global Quality Documents are classified in alignment with the Sanofi Global Process
Framework.

6.1 Quality Processes

The Global Quality documents are grouped in alignment with the Quality processes
covering the GxP regulated activities, as well as other health-related regulations.
There are three categories of Quality processes:
• Product Life-Cycle Processes, directly contributing to the design, development
and realization of effective and safe products and services for the benefit of
patients and consumers.
• Transversal Processes, supporting the Product Life-Cycle Processes, in order to
ensure their proper management, control and continuous improvement.
• Organizational Processes, contributing to the organization and management
of the Sanofi Quality System, by providing consistent directions and adequate
support.
6.1.1 Product Life-Cycle Processes

PRODUCT LIFE-CYCLE PROCESSES

RESEARCH
Research

LABORATORY STUDY
Laboratory Test & Reference
Laboratory Bioanalysis &
Animal Compounds
Study Conduct Pharmacokinetics
Management Management

MEDICAL AND CLINICAL

Clinical Development Regulatory
Post-Authorization Submission & Scientific and Medical
Pharmacovigilance
Studies and Maintenance Information & Ethics
Programs

MANUFACTURING AND DISTRIBUTION

Design & Technology Facilities, Utilities & Qualification &

Development Transfer Equipment Validation

Manufacturing & Product

Packaging Control & Release Supply Chain Discontinuation

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Research Process:
PROCESS OBJECTIVE
Research Ensure that the first stages of product development, including
basic scientific exploration and discovery as well as studies and
analysis of early development which are not covered by GxPs
are properly organised, performed, documented and archived
in order to ensure the integrity of data, the protection of
intellectual property and an adequate dossiers submission.

Laboratory Study Process:

PROCESS OBJECTIVE
Laboratory Animal Manage all aspects related to the care and use of laboratory
Management animals, in alignment with the fundamental principles of animal
welfare.
Test & Reference Manage any article that is either the subject of a laboratory study
Compounds or provides a basis for a comparison with the study object.
Management
Laboratory Study Ensure the proper management of laboratory studies, starting
Conduct from the protocol, the generation of study data, the production
of the report, and ending with the data archiving.
Bioanalysis & Analyse biological samples with the aim to provide knowledge
Pharmacokinetics and understanding of the disposition of the product in animals
and humans.

Medical and Clinical Process:

PROCESS OBJECTIVE
Clinical Conduct studies and programs in humans for all products in
Development, clinical development and post-authorization to provide
Post-Authorization knowledge and documentation necessary for the worldwide
Programs registration of new products or new indications or line
extensions, as well as medical and clinical knowledge
throughout the product lifecycle.
Pharmacovigilance Ensure establishment of the safety profile and contribution to
evaluation of the therapeutic value for all products in clinical
development.
Ensure continuous monitoring and management of the safety
profile, and risk minimization of all products marketed by the
Company.
Coordinate and ensure Benefit-Risk assessment throughout the
product lifecycle for continuous monitoring of risks and benefits
of medicinal products
Regulatory Manage regulatory activities required to submit information to
Submission & the regulatory authorities, obtain approval, and maintain the
Maintenance Sanofi portfolio.

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Scientific and Ensure ethical and responsible conduct when dealing with
Medical patients, consumers and subjects participating to studies and
Information & programs.
Ethics Ensure scientific and medical information is provided according
to international standards to patients, healthcare professionals
and consumers.

Manufacturing and Distribution Process:

PROCESS OBJECTIVE
Design & Ensure the product and process design and development is
Development suitable for routine commercial manufacturing that can
consistently deliver a product that meets its quality attributes.
Build quality by design and define the control strategy to ensure
adequate product quality, purity and strength for its intended
purposes and to satisfy patient needs and costumer
expectations.
Technology Ensure that product transfers result in robust, reliable, cost-
Transfer effective and appropriate manufacturing, packaging and testing
controls and that the transferred products comply with
applicable regulatory and Company requirements.
Facilities, Utilities Design, manage, maintain and decommission facilities, utilities
and Equipment and equipment used to conduct laboratory, manufacturing and
distribution activities related to Sanofi products to ensure the
quality of the studies and products and to minimise the risk of
contamination.
Qualification & Demonstrate compliance of the critical aspects of the
Validation development, manufacturing, control and distribution of Sanofi
products with pre-established requirements.
Manufacturing & Manufacture and package products to consistently meet all the
Packaging required quality attributes and specifications.
Control & Release Ensure that materials, intermediates and finished products are
sampled, analysed and formally released by Quality
Management before use or distribution.
Supply Chain Ensure the timely delivery to production of the right quantity
and quality of materials, for use in the manufacturing and
packaging of Sanofi products.
Manage the physical flows of Sanofi materials and products
while maintaining their quality, security and traceability.
Ensure that Sanofi customers receive the right quality product,
at the right time.
Ensure when a product is deemed unfit based on adequate
investigation, product discontinuation actions are properly
taken.

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Product Manage the activities associated with the terminal stage of the
Discontinuation product lifecycle, such as retention of documentation and
samples, and continued product assessment and reporting in
accordance with regulatory requirements.

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6.1.2 Transversal Processes

TRANSVERSAL PROCESSES

Management of
Management of Product & Process Personnel Training Management of
Computerised
Documentation Improvement & Third Parties
Systems

Transversal processes are classified under the “G8-Quality Systems Management” sub-
process of the Sanofi Global Process Framework.

PROCESS OBJECTIVE
Management of Ensure that documents and records supporting regulated
Documentation activities are issued, managed, controlled and archived in a way
to accurately reflect the complete history of Sanofi products and
services throughout their lifecycle.
Product & Process Enhance products and improve processes to consistently and
Improvement better meet the needs of customers and patients, and to
promote innovation and enhance performance while respecting
the related regulatory and Company requirements.
Personnel Training Ensure that the personnel involved in the Sanofi Quality
& Qualification Processes are trained and qualified for their assigned tasks.
Management of Ensure that service providers, suppliers and subcontractors,
Third Parties who perform one or several steps in the lifecycle of Sanofi
products and services, and who supply materials and GxP
services associated with this lifecycle, are selected and
managed in accordance with business and quality requirements.
Management of Ensure that computerised systems and digital solutions, used in
Computerised support of regulated activities are designed, implemented,
Systems validated and operated in a way to fulfil the applicable
regulatory and Company requirements.

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 6.1.3 Organizational Processes
Organizational processes are classified under the “G8-Quality Systems Management” sub-
process of the Sanofi Global Process Framework.

ORGANIZATIONAL PROCESSES

Quality Systems Quality Risk

Quality Audit
Management Management

PROCESS OBJECTIVE
Quality Systems Deploy the Quality Policy across Sanofi through the
Management implementation and monitoring of Quality Systems, based
upon the related regulatory and Company requirements.
Quality Audit Provide an accurate, independent assessment of the
compliance of the Operational Units, Sites, Countries, Global
Functions and third parties to the Sanofi Quality Management
System.
Quality Risk Implement a systematic, consistent and efficient process for
Management the identification, assessment, remediation/mitigation,
escalation, monitoring/review and communication of risks
related to the quality and compliance of the products, services
and activities by each Operational Unit, Site, Country and
Functions, throughout the product/services lifecycle.

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6.2 Documentation Hierarchy

As part of the simplification program initiated within Sanofi, the Global Quality
documentation hierarchy is being revamped to replace the historical “Global Quality
Directive (QGQD)”, “Global Quality Standard (QOQS)” and “Global Quality Guidance
(QOQG)” by “Standard (STD)” and “Global Procedure (GOP)”. These two documentation
hierarchies will therefore coexist until the transition process is fully completed
(scheduled for end 2022).

The new Sanofi Global QMS documentation hierarchy is displayed in the following
diagram:

The process to establish, review, approve and distribute Global Quality documents as
well as their supporting documents is detailed in the Global Procedure “Lifecycle
Management of Global Functions Documents”.

Global Quality documents are developed for each type of GxP and public health-related
regulation: research and laboratory studies, clinical and medical, manufacturing and
distribution, commercial Country activities and information systems.

GxP documents used at all levels of the Sanofi Quality Documentation System are
subject to the requirements set forth by the Global Quality Document Management of
GxP Documents and Records and are available for inspection by regulatory authorities.

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6.3 Quality Documents Type
DOCUMENT OBJECTIVE
TYPE

Quality Describes the overall intentions and direction of the Sanofi Company
Policy related to Quality. The Quality Policy is endorsed by the Sanofi Chief
Quality Officer and by the Chief Executive Officer. The Quality Policy
includes the expectation to comply with applicable regulatory and
company requirements and promotes continuous improvement. The
Quality Policy is communicated to personnel at all levels of the Company.
Quality Contains the description of the QMS including the Quality Policy, the scope
Manual of the QMS, the Quality processes with their sequences, linkages and
interdependencies and Management responsibilities. The Quality Manual
is endorsed by the Sanofi Chief Quality Officer.
Standards Describe mandatory regulatory and Company requirements for specific or
transversal activities, which must be complied with. Apply to one or
several product ranges. Applicable to all Sanofi entities involved in the
activities described.
Position Describe the Sanofi position regarding a specific topic not necessarily
Papers associated with mandatory regulatory requirements. The position paper
can be issued either for external communication or for internal use.
Supporting Help to standardise the implementation of quality documents (typically
Documents templates, logs, checklists, etc.). Can be associated with Standards,
Global Standard Operating Procedures or any local document. Mandatory
document to be used, unless otherwise specified in the supported
document.
Global Give instructions for performing operations which are transversal across
Operating different entities or functions. Applicable to all Operational Units, Sites,
Procedures Countries or Functions performing the described activity. The Global
Operating Procedures are directly used at local level when applicable or
cascaded in a platform or local document.
Local Quality Give instructions for performing operations which are specific to a Site, a
Documents Country or a Function.

Note: Former Global Quality document types such as Global Quality Directives,
Operational Quality Standards and Operational Quality Guidances are being
maintained during the transition period of the simplification documentation
architecture project lasting until end. The purpose of these historical documents
is described in the hereunder table.

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 Quality Manual V8.0

DOCUMENT OBJECTIVE
TYPE

Global Describe mandatory regulatory requirements for key processes which

Quality must be complied with across the Company. Apply to all activities and all
Directives product ranges.
Operational Describe regulatory and Company requirements and current practices, for
Quality specific or transversal activities, which must be complied with. Apply to
Standards one or several product ranges. Applicable to all Sanofi entities involved in
the activities described.
Operational Describe the Sanofi detailed and current expectations on how to satisfy
Quality the requirements of applicable Operational Quality Standards and Global
Guidances Quality Directives. Apply to one or several product ranges. Applicable to
all entities of Sanofi involved in the activities they describe.

7 Global Quality Audits and

Regulatory Inspections

Sanofi Operational Units, Sites, Countries and Functions are periodically audited to verify
compliance with the Sanofi QMS. These audits are performed by the Global Quality Audit
team and the audit frequency, duration and number of auditors is determined using a
risk-based model. The audit approach and audit system used have been accredited to
ISO/IEC 17020:2012, which is an international standard specifying requirements for the
competence of bodies performing audits as well as for the impartiality and consistency
of the audit activities.

These audits also facilitate readiness of the Sanofi entities and functions for regulatory
authority inspections, ensuring that Sanofi is meeting all regulatory obligations and
commitments.

A key aspect of the Quality Management System is to ensure that all relevant Sanofi
entities are prepared at all times to receive Regulatory Authorities’ inspections. To ensure
on-going inspection readiness the following tools and support are provided:
• Inspection Preparation can be provided from Global Quality Audit and Operational
Quality Units. This support can be provided both prior to and during inspections.
• Mock Audits can be performed by Global Quality Audit either at request of the
entity, Global Quality Functions, Operation Quality Units, and Site or Country
Quality Management. Mock audits are also used as part of the Pre-Approval
Inspection Management process.
When deviations from internal or external requirements are identified during audits or
regulatory inspections, corrective and preventive action plans are put in place and
monitored until resolution.

Global Quality Audit is also responsible for coordinating (in partnership with R&D Sites

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Quality Operations) GxP evaluations in the due diligence for product, process or
company acquisitions involving a cluster of countries, a single region or multiple regions
/ global projects. In addition, Global Quality Audit is responsible to carry out a baseline
audit within 6 months of such acquisitions.

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 Quality Manual V8.0

8 Document Approvals

This document is electronically approved in GEODE+.

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 9 Document History
December 2009 - V 1.0
• First version of this Global QM

June 2011 - V 2.0

• Creation of Global Operations Quality
• Creation of the Risk Committee
• Minor modifications of the process model:
- Commercial activities is replaced by Scientific and Medical Information and Marketing
activities
- Support processes are renamed Transversal processes
- Clinical development and post-Marketing studies are merged
- Laboratory studies managed as a separated domain
• New section on Responsibilities for Computerized Systems
• New section on integration of new entities
• Integration of Merial and Genzyme
• Changes in the definition and applicability of Operational Quality Guidances
• Addition of a paragraph related to Quality Liaisons
• Added several regulatory references
• Minor editorial changes

July 2013 - V 3.0

• Seventh growth platform added for rare diseases
• Genzyme and Merial added to the group’s organization
• Creation of the Executive Compliance Committee and Bioethics Committee
• Creation of the Global Quality Strategy Office
• Products containing software (e.g. iBGStar)
• Section added on the role of Senior Management
• Clarification that global quality documents are inspectable by regulatory authorities
• Clarification that Global Quality Directives apply immediately to integrated companies,
regardless of the integration model
• Role of quality in the due diligence process
• Modifications of the process model:
- New process for early Research
- Detailed processes for Laboratory Studies (laboratory animals, test and reference
compounds, study conduct, bioanalysis and pharmacokinetics)
- Added process for Health Ethics and Transparency

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 Quality Manual V8.0

• Minor update of glossary and references

February 2016 - V 4.0

• Combination product and sub-categories of veterinary products introduced
• 3 main business segments introduced (Pharma, Human vaccines and Animal Health
replaced and the seven platforms for sustainable growth)
• New Sanofi organization and activities
• Introduction of the Global Business Units including diabetes and cardiovascular,
general medicines and emerging markets, Sanofi Genzyme, Sanofi Pasteur, and Merial
• New Sanofi Quality Policy
• Update of the Global Quality Organization and functions
• The Affiliate Quality Officer was renamed Country Quality Head and precisions were
given on the country’s responsibilities
• The paragraph defining the responsibilities of Supply Chain was moved in section 4.7
• Sites involved in development and manufacturing of medical devices must establish a
local Quality Manual
• Global Documents introduced
• Modifications of the process model:
- Added process for Marketing and Sales in the new Marketing and Sales domain
- Added process for Medical Benefit and Risk Governance in Clinical and Medical
domain
- Clinical Development & Post-Marketing Studies process renamed Clinical
Development & Post-Authorization Studies
- Scientific and Medical Information and Marketing process renamed Scientific and
Medical
- Information
- Product discontinuation process removed from the Manufacturing and Distribution
domain
• New section Personnel Training and Qualification
• Quality Intelligence, Quality Commissions, Risk Commissions and Quality
Communication introduced in Continuous Improvement of the Quality System section
• Update of the Quality Risk Management section
• Minor update of glossary and references

November 2017 – V5.0

• Simplification of content and format in alignment with the Company objective of focus
and simplification.
• New Sanofi Chief Quality Officer
• New Sanofi Quality Organization
• Clarification of the link between the Quality Processes and the Quality Documentation
• New section on enablers of the QMS, including Knowledge Management and Quality

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 Culture
• New format of the QM
• Minor editorial changes

November 2019 – V6.0

• Update of the Sanofi Organization and Sanofi GBUs
• Updated the Quality Policy and Quality organization (chart and responsibilities).
Introduction of ‘Global Quality External Liaison’ as well as ‘Process and System
Owners’ responsibilities
• Updated ‘Quality Risk Management’ and ‘Quality Culture’ Enablers. Introduction of a
new section ‘Data Integrity’
• Updated ‘Research’ and ‘Product and Process Improvement’ processes objective in the
section Global Quality Documentation System
• New documentation pyramid. Update of document types and few words about the
transition period before the complete transition to the new pyramid.
• Global Quality Audits and Regulatory Inspections updated (ISO 17020 accreditation
and due diligence process).
• Minor editorial changes

December 2020 – V7.0

• Update of the Forewords
• Update of Section 1.4 Our Business Strategy with the new Sanofi Strategy
• Update of section 1.6 Our values which becomes section 1.6 Our behaviors
• Update of Section 1.7 Sanofi Organization and Activities: Removal of Primary Care
and China and emerging market, removal of the Chief medical office & Medical
function, addition of General medicine as a GBU, SAIS as the unit in charge of API
manufacturing and Digital office
• Update of Section 3.1 Organization Chart with the new organization
• Update of Section 3.3 Global Quality Functions with Global Quality Management
System and Digital transformation replacing Global Quality Strategy, Compliance and
Transformation.
• Update of Section 3.4 Operational Quality Unit: MCCQ head no longer reporting to
Chief Medical Office, addition of SAIS and replacement of ITS QO by Digital Quality
Operation
• Update of Section 3.6 Operational Quality Units: removal of the delegation of a
qualified person for R&D activities at country level
• Update of Section 6.1.1 Product lifecycle processes for the process
“Pharmacovigilance” with the addition of the coordination of the Benefit-Risk
assessment and for the process “Scientific and Medical Information & Ethics” with the
removal of the establishment of a governance for the medical benefit risk balance.
• Addition in section 3.3 Global Quality function and section 7 Global Quality Audits and
Regulatory Inspections that R&D contribute with GQA to due diligence audits
• Minor editorial changes

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 Quality Manual V8.0

February 2022 – V8.0

• Update to integrate new branding new logo, colour, font and picture.
• Update Section 1.7 Sanofi Organisation and activities, removal of “One unit in charge of
API manufacturing: SAIS”
• Update of Section 2. Sanofi Quality Policy with new branded Policy
• Update of Section 3.1 Organization Chart with new organization
• Update of Section 3.3 Global Quality Functions with GQA and External Liaison mission
• Minor editorial changes

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