Global Quality Manual PDF
Global Quality Manual PDF
Global Quality Manual PDF
QUALITY MANUAL
VERSION 6.0
NOVEMBER 2019
Quality Manual V6.0
GxP Combined term for GCP, GDP, GCLP, GLP, GMP, GRP, GVP
IA Industrial Affairs
2
Quality Manual V6.0
Foreword
I am pleased to share with you the Global Quality Manual 6.0 edition.
This edition reflects the most recent changes to the Quality organization aligned
with Global Business Units, Global Functions, Country organizations, the Sanofi
Industrial Platforms, and finally Sanofi Values.
New points of focus are described and are enablers for an effective and
successful implementation of the Quality Management System. The Quality
Academy is highlighted as it provides training resources and is a promotor for
continuous learning and education of our people at all levels.
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 life-cycle from
research to development, 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.
In line with our Company objective of focus and simplification, 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 September 2019. The Quality Policy and Quality
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.
Philippe Germanaud
Chief Quality Officer
Quality Manual V6.0
Table of Contents
4
Quality Manual V6.0
4.4 Measuring......................................................................................................... 15
4.5 Reviewing ......................................................................................................... 16
4.6 Improving.......................................................................................................... 16
4.7 Other Areas of Management Responsibilities .................................................. 16
4.7.1 Management of Change in Product Ownership ................................................ 16
4.7.2 Monitoring of Internal and External Factors impacting the Quality
Management System ........................................................................................ 16
5. Enablers ................................................................................. 17
5.1 Quality Risk Management ................................................................................ 17
5.2 Knowledge Management .................................................................................. 17
5.3 Quality Culture .................................................................................................. 17
5.4 Data integrity .................................................................................................... 17
9. Document History.................................................................. 27
5
Quality Manual V6.0
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.
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.
6
Quality Manual V6.0
RESPECT INTEGRITY
Showing empathy and
Operating with honesty and
embracing the diversity,
transparency, ensuring the
different thoughts and needs
highest ethical and
of our people, customers,
quality standards
communities
7
Quality Manual V6.0
• Five Global Business Units (GBUs) integrating global franchises, country level commercial
and medical organizations for each of our major businesses:
• Specialty Care (Sanofi Genzyme) - Rare Diseases, Multiple Sclerosis, Oncology &
Immunology
• Primary Care (Diabetes, Cardiovascular diseases and established products)
• China and Emerging Markets (established products and all pharmaceutical sales
including Sanofi Genzyme and Diabetes and Cardiovascular, in emerging markets)
• Vaccines (Sanofi Pasteur)
• Consumer Healthcare
• Various Global Functions
• Business transformation
• Chief Medical Office & Medical Function
• External Affairs
• Finance
• Global Business Services
• Global Industrial Affairs
• Global Research & Development
• Human Resources
• Internal Audit & Risk Management
• Legal, Business Integrity & Ethics
• Strategy & Business Development.
8
Quality Manual V6.0
9
Quality Manual V6.0
Chief Executive
Officer Global IA Head
Chief Quality
Officer
Global ITS
Quality &
Compliance
Operations
Operation in dotted line to the CQO Function in solid line to the CQO Operation solid line to the CQO
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 Council,
the Sanofi Global Risk Committee and the Sanofi Global Compliance Committee.
10
Quality Manual V6.0
The mission of the Global Quality Strategy, Compliance & Transformation (GQ SC&T) is to drive the
Sanofi Global Quality strategy built upon the strategic orientations of the Company, the principles
defined in ICH Q10 Pharmaceutical Quality System and applicable health-related regulations to
assure patient safety and product quality.
This mission is achieved through the following Global Quality functional areas reporting to the Head
of GQ SC&T:
The mission of Global Quality Audit is to provide to the Senior Management an accurate, independent
assessment of the compliance to the Sanofi Quality Management System through regular
surveillance audits of the Operational Units, Sites (R&D, Manufacturing and Distribution), Country
Offices, Global Functions and key third parties, including due diligence assessments. GQA also
supports regulatory inspection readiness.
The mission of Global Quality external liaison is to lead the Quality external strategy and actively play
a strong influencing role in external pharmaceutical industry associations and regulatory agencies to
advocate and promote the Sanofi “One-Voice Quality”.
11
Quality Manual V6.0
12
Quality Manual V6.0
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.
13
Quality Manual V6.0
These requirements apply during the whole system life-cycle including design, development,
validation, use, support, maintenance and decommissioning.
The Information Technology & Systems Operational Quality 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 life-cycle.
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.
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.
14
Quality Manual V6.0
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 identify areas for
continuous improvements.
15
Quality Manual V6.0
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.
16
Quality Manual V6.0
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.
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.
17
Quality Manual V6.0
RESEARCH
Research
LABORATORY STUDY
18
Quality Manual V6.0
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.
19
Quality Manual V6.0
20
Quality Manual V6.0
TRANSVERSAL PROCESSES
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 activities are
Documentation issued, managed, controlled and archived in a way to accurately reflect the
complete history of Sanofi products and services throughout their life-
cycle.
Product & Process Enhance products and improve processes to consistently and better
Improvement 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 Processes are
Qualification trained and qualified for their assigned tasks.
Management of Third Ensure that service providers, suppliers and subcontractors, who perform
Parties one or several steps in the life-cycle of Sanofi products and services, and
who supply materials and GxP services associated with this life-cycle,
are selected and managed in accordance with business and quality
requirements.
Management of Ensure that computerised systems and digital solutions, used in support
Computerised of regulated activities are designed, implemented, validated and
Systems operated in a way to fulfil the applicable regulatory and Company
requirements.
21
Quality Manual V6.0
ORGANIZATIONAL PROCESSES
Organizational processes are classified under the “G8-Quality Systems Management” sub-process of
the Sanofi Global Process Framework.
PROCESS OBJECTIVE
Quality Systems Deploy the Quality Policy across Sanofi through the implementation and
Management 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 the
Management 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 life-
cycle.
22
Quality Manual V6.0
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.
23
Quality Manual V6.0
Quality Policy Describes the overall intentions and direction of the Sanofi Company 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 Manual Contains the description of the QMS including the Quality Policy, the scope 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 Papers Describe the Sanofi position regarding a specific topic not necessarily 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 templates,
Documents 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 different
Operating entities or functions. Applicable to all Operational Units, Sites, Countries or Functions
Procedures 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 Country or
Documents 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
2024. The purpose of these historical documents is described in the hereunder table.
DOCUMENT OBJECTIVE
TYPE
Global Quality Describe mandatory regulatory requirements for key processes which must be
Directives complied with across the Company. Apply to all activities and all product ranges.
Operational Describe regulatory and Company requirements and current practices, for specific or
Quality transversal activities, which must be complied with. Apply to one or several product
Standards ranges. Applicable to all Sanofi entities involved in the activities described.
Operational Describe the Sanofi detailed and current expectations on how to satisfy the
Quality requirements of applicable Operational Quality Standards and Global Quality
Guidances Directives. Apply to one or several product ranges. Applicable to all entities of Sanofi
involved in the activities they describe.
24
Quality Manual V6.0
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 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.
25
Quality Manual V6.0
8 Document Approvals
This document is electronically approved in GEODE+.
26
Quality Manual V6.0
9 Document History
December 2009 - V 1.0
• First version of this Global QM
27
Quality Manual V6.0
28
Quality Manual V6.0
29
54, rue La Boétie
75008 Paris, France
http://www.sanofi.com/
Photo credit: Stockbyte / Getty Image