INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL

REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

DRAFT CONSENSUS GUIDELINE

PHARMACEUTICAL QUALITY SYSTEM

Q10

Current Step 2 version

dated 9 May 2007

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by

the appropriate ICH Expert Working Group, is transmitted by the ICH Steering
Committee to the regulatory authorities of the three ICH regions (the
European Union, Japan and the USA) for internal and external consultation,
according to national or regional procedures.
 Q10
Document History

Current Step 2 version

New
Codificatio
First n
History Date
Codification
Novembe
r 2005

Q10 Approval by the Steering Committee under Step 9 May Q10

2 and release for public consultation. 2007
 PHARMACEUTICAL QUALITY SYSTEM

Draft ICH Consensus Guideline

Released for Consultation on 9 May 2007, at Step 2 of the ICH Process

TABLE OF CONTENTS
1. Pharmaceutical quality System..................................................1
1.1 Introduction...............................................................................................1
1.2 Scope................................................................................................ .........1
1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards
and ICH Q7......................................................................................................3
1.4 Relationship of ICH Q10 to Regulatory Approaches...................................3
1.5 ICH Q10 Objectives....................................................................................3
1.6 Enablers................................................................................................ .....4
1.7 Design and Content Considerations ..........................................................4
1.8 Quality Manual........................................................................................ ...5
2. Management Responsibility.......................................................5
2.1 Management Commitment........................................................................5
2.2 Quality Policy.............................................................................................5
2.3 Quality Planning........................................................................................6
2.4 Resource Management..............................................................................6
2.5 Internal Communication............................................................................6
2.6 Management Review.................................................................................6
2.7 Oversight of Outsourced Activities............................................................6
3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND
PRODUCT QUALITY............................................ .................7
3.1 Lifecycle Stage Goals ............................................................................... 7
3.2 Pharmaceutical Quality System Elements.................................................8
4. Continual Improvement of the Pharmaceutical Quality System. .13
4.1 Management Review of the Pharmaceutical Quality System ..................13
4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical
Quality System..............................................................................................13
4.3 Outcomes of Management Review and Monitoring.................................13
5. GLOSSARY..................................................... ..........................14
Annex 1 16
Potential Opportunities to Enhance Science and Risk Based Regulatory
Approaches *.................................................................................................16

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 PHARMACEUTICAL QUALITY SYSTEM

1. PHARMACEUTICAL QUALITY SYSTEM

1.1 Introduction
This document establishes a new ICH tripartite guideline describing a model
for an effective quality management system for the pharmaceutical industry,
referred to as the Pharmaceutical Quality System.
ICH Q10 describes one comprehensive approach to an effective
pharmaceutical quality system that is based on ISO concepts, includes
applicable Good Manufacturing Practice (GMP) regulations and complements
ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk
Management”. ICH Q10 is a model for a pharmaceutical quality system that
can be implemented throughout the different stages of a product lifecycle.
Much of the content of ICH Q10 applicable to manufacturing sites is currently
specified by regional GMP requirements. ICH Q10 is not intended to create
any new expectations beyond current regulatory requirements. Consequently,
the content of ICH Q10 that is additional to current GMP requirements is
optional.
Throughout this guideline, the term “pharmaceutical quality system” refers to
the ICH Q10 model.
ICH Q10 demonstrates industry and regulatory authorities’ support of an
effective pharmaceutical quality system to enhance the quality and availability
of medicines around the world in the interest of public health. Implementation
of ICH Q10 throughout the product lifecycle should facilitate innovation and
continual improvement and strengthen the link between pharmaceutical
development and manufacturing activities.

1.2 Scope
This guideline applies to pharmaceutical drug substances and drug products,
including biotechnology and biological products, throughout the product
lifecycle.
The elements of ICH Q10 should be applied in a manner that is appropriate
and proportionate to each of the product lifecycle stages, recognizing the
differences among, and the different goals of each stage (described later in
Section 3).
For the purposes of this guideline, the product lifecycle includes the following
technical activities for new and existing products:
• Pharmaceutical Development
o Drug substance development;
o Novel excipient development;
o Formulation development (including container/closure system);
o Delivery system development (where relevant);
o Manufacturing process development and scale-up;
o Analytical method development.
• Technology Transfer
o New product transfers from Development to Manufacturing;

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Pharmaceutical Quality System

o Transfers within or between manufacturing and testing sites for

marketed products.

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 Pharmaceutical Quality System

• Manufacturing
o Procurement of materials;
o Provision of facilities, utilities and equipment;
o Production (including packaging and labelling);
o Quality control and assurance;
o Release;
o Storage;
o Distribution (excluding wholesaler activities).
• Product discontinuation
o Retention of documentation;
o Sample retention;
o Continued product assessment and reporting.

1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO

Standards and ICH Q7
Regional Good Manufacturing Practice requirements, the ICH Q7 Guideline and
ISO Quality Management System Guidelines form the foundation for ICH Q10.
To meet the objectives described below, ICH Q10 augments GMPs by
describing specific quality system elements and management responsibilities.
ICH Q10 thereby serves as a bridge between the regional requirements,
helping industry and regulators achieve harmonisation of the pharmaceutical
quality system throughout the lifecycle of a product.

1.4 Relationship of ICH Q10 to Regulatory Approaches

Regulatory approaches for a specific product or manufacturing facility should
be commensurate with the level of product and process understanding, the
results of quality risk management, and the effectiveness of the
pharmaceutical quality system. When implemented, the effectiveness of the
pharmaceutical quality system can normally be confirmed during a regulatory
inspection at the manufacturing site. Potential opportunities to enhance
science and risk based regulatory approaches are identified in Annex 1.
Regulatory processes will be determined by region.

1.5 ICH Q10 Objectives

i) Achieve Product Realisation
To establish, implement and maintain a set of processes that provides a
product with the quality attributes appropriate to meet the needs of
patients, health care professionals, regulatory authorities (including
compliance with marketing authorisations) and internal customers.
ii) Establish and Maintain a State of Control
To develop and use effective monitoring and control systems for process
performance and product quality, thereby providing assurance of
continued suitability and capability of processes. Quality risk
management can be useful in establishing the monitoring and control
system.
iii) Facilitate Continual Improvement
To identify and implement appropriate product quality improvements,
process improvements, variability reduction, innovations, and

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Pharmaceutical Quality System

pharmaceutical quality system enhancements, thereby increasing the

ability to consistently fulfil quality needs. Quality risk management can
be useful to identify and prioritise areas for improvement.

1.6 Enablers
Knowledge management and quality risk management are enablers of ICH
Q10 that facilitate a consistent scientific approach to achieve the objectives
described in 1.5 above. These enablers should provide the means for science-
and risk–based decisions related to product quality.
i) Knowledge management
Knowledge should be managed from development through the
commercial life of the product up to and including product
discontinuation. Knowledge management is a systematic approach to
acquiring, analyzing, storing and disseminating information related to
products, processes and components. Sources of knowledge include,
but are not limited to, prior knowledge (public domain or internally
documented), pharmaceutical development studies, technology transfer
activities, process validation studies over the product lifecycle,
manufacturing experience, continual improvement and change
management activities.
ii) Quality risk management
Quality risk management can provide a proactive approach to
identifying and controlling potential risks to quality throughout the
product lifecycle. ICH Q9 describes a model for quality risk management
approaches within a pharmaceutical context.

1.7 Design and Content Considerations

i) The pharmaceutical quality system should be well structured and clear
to facilitate common understanding and consistent application.
ii) The elements of ICH Q10 should be applied in a manner that is
appropriate and proportionate to each of the product lifecycle stages,
recognizing the differences among, and the different goals of each
stage.
iii) The size and complexity of the company’s activities should be taken into
consideration when developing a new pharmaceutical quality system or
modifying an existing one. While some aspects of the pharmaceutical
quality system can be company-wide and others site-specific, the
effectiveness of the implementation of the pharmaceutical quality
system is normally demonstrated at the site level.
iv) Outsourced (contracted) activities should be within the scope of the
pharmaceutical quality system.
v) Management responsibilities, as described in Section 2, should be
identified within the pharmaceutical quality system.
vi) The pharmaceutical quality system should include the following
elements: process performance and product quality monitoring,
corrective and preventive action, change management and
management review, as described in Section 3.

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 Pharmaceutical Quality System

vii) Key performance indicators should be identified and used to monitor the
effectiveness of processes within the pharmaceutical quality system as
described in Section 4.

1.8 Quality Manual

A Quality Manual or equivalent documentation approach should be established
and should contain the description of the pharmaceutical quality system. The
description should include:
i) The quality policy (further described in Section 2).
ii) The scope of the pharmaceutical quality system.
iii) Identification of the processes within the pharmaceutical quality system,
as well as their sequences, linkages and interdependencies. Process
maps and flow charts can be useful tools to facilitate depicting these in
a visual manner.
iv) Management responsibilities within the pharmaceutical quality system,
as described in Section 2 of this document.

2. MANAGEMENT RESPONSIBILITY
Leadership is essential to establish and maintain a company-wide commitment
to quality and for the performance of the pharmaceutical quality system.

2.1 Management Commitment

i) Senior management has the ultimate responsibility to ensure an
effective pharmaceutical quality system is in place, and that
responsibilities and authorities are defined, communicated and
implemented throughout the company.
ii) Management should:
(1) Participate in the design, implementation and monitoring of the
pharmaceutical quality system;
(2) Demonstrate strong and visible support for the pharmaceutical
quality system and ensure its implementation throughout their
organization;
(3) Ensure a timely and effective communication and escalation process
exists to raise quality issues to the appropriate levels of
management;
(4) Define and communicate individual and collective roles,
responsibilities and authorities of all organizational units related to
the pharmaceutical quality system, and ensure interactions are
defined and understood. An independent quality unit/structure with
authority to fulfil certain pharmaceutical quality system
responsibilities is required by regional regulations;
(5) Conduct management reviews of process performance and product
quality and of the pharmaceutical quality system;
(6) Advocate continual improvement;
(7) Commit appropriate resources.
2.2 Quality Policy

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Pharmaceutical Quality System

i) Senior management should establish a quality policy that describes the

overall intentions and direction of the company related to quality.
ii) The quality policy should include an expectation to comply with
applicable regulatory requirements and should facilitate continual
improvement of the pharmaceutical quality system.
iii) The quality policy should be communicated to and understood by
personnel at all levels in the company.
iv) The quality policy should be reviewed periodically for continuing
effectiveness.

2.3 Quality Planning

i) As part of quality planning, senior management should ensure the
quality objectives needed to implement the quality policy are defined
and communicated.
ii) Quality objectives should be supported by all relevant levels of the
company.
iii) Quality objectives should align with the company’s strategic plans and
be consistent with the quality policy.
iv) Management should provide the appropriate resources and training to
achieve the quality objectives.
v) Key performance indicators that measure progress against quality
objectives should be established, monitored, communicated regularly
and acted upon as appropriate.

2.4 Resource Management

i) Management should determine and provide adequate and appropriate
resources (human, financial, materials, facilities and equipment) to
implement and maintain the pharmaceutical quality system and
continually improve its effectiveness.
ii) Management should ensure that resources are appropriately applied to
a specific product, process or site.

2.5 Internal Communication

i) Management should ensure appropriate communication processes are
established and implemented within the organization.
ii) Communications processes should ensure the flow of appropriate
information between all levels of the company.
iii) Communication processes should ensure the escalation of certain
product quality and pharmaceutical quality system issues to appropriate
levels of management in a timely manner.

2.6 Management Review

Senior management should be responsible for pharmaceutical quality system
governance through management review to ensure its continuing suitability
and effectiveness. Management should assess the conclusions of periodic
reviews of process performance and product quality and of the pharmaceutical
quality system, as described in Sections 3 and 4.

2.7 Oversight of Outsourced Activities

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 Pharmaceutical Quality System

A pharmaceutical company can outsource activities at all stages of the product

lifecycle. The pharmaceutical quality system, including the management
responsibilities described in this section, extends to the oversight and review
of outsourced activities. Normally under a contract, the contract giver should
be responsible for assessing the suitability and competence of the contract
acceptor to carry out the work required. Responsibilities for quality-related
activities of the contract giver and contract acceptor should be specified in a
written agreement.

3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND

PRODUCT QUALITY
Regional GMP requirements and the ICH Q7 guideline form the foundation of
ICH Q10. This section describes the four specific pharmaceutical quality
system elements that augment this foundation. to achieve the ICH Q10
objectives. It does not restate all regional GMP requirements. The elements
described below might be, in part, required under regional GMP regulations;
however, the intent is to enhance these elements in order to promote the
lifecycle approach to product quality. These four elements are:

• Process performance and product quality monitoring system;

• Corrective action and preventive action (CAPA) system;
• Change management system;
• Management review of process performance and product
quality.
These elements should be applied in a manner that is appropriate and
proportionate to each of the product lifecycle stages, recognizing the
differences among, and the different goals of each stage. Throughout the
product lifecycle, companies should evaluate opportunities for innovative
approaches to improve product quality.
The goals of each product lifecycle stage are described below, followed by
examples of how each pharmaceutical quality system element is applied to
that product lifecycle stage.

3.1 Lifecycle Stage Goals

i) Pharmaceutical Development
The goal of pharmaceutical development activities is to design a
product and its manufacturing process to consistently deliver the
intended performance and meet the needs of patients, healthcare
professionals, regulatory authorities and internal customers. Approaches
to pharmaceutical development are described in ICH Q8. The results of
exploratory and clinical development studies, which are outside the
scope of this guidance, are inputs to pharmaceutical development.
ii) Technology Transfer
The goal of technology transfer activities is to transfer product and
process knowledge between development and manufacturing, and
within or between manufacturing sites to achieve product realisation.
This knowledge forms the basis for the manufacturing process, control

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Pharmaceutical Quality System

strategy, process validation approach and ongoing continual

improvement.
iii) Manufacturing
The goals of manufacturing activities include achieving product
realisation, establishing and maintaining a state of control and
facilitating continual improvement. The pharmaceutical quality system
should assure that the desired product quality is routinely met, suitable
process performance is achieved, the set of controls are appropriate,
improvement opportunities are identified, and the body of knowledge is
continually expanded.
iv) Product Discontinuation
The goal of product discontinuation activities is to effectively manage
the terminal stage of the product lifecycle. For product discontinuation,
a pre-defined approach should be used to manage activities such as
retention of documentation and samples and continued product
assessment (e.g., complaint handling and stability) and reporting in
accordance with regulatory requirements.

3.2 Pharmaceutical Quality System Elements

i) Process Performance and Product Quality Monitoring System
Pharmaceutical companies should plan and execute a system for the
monitoring of process performance and product quality to ensure a state
of control is maintained. An effective monitoring system provides
assurance of the continued capability of processes and controls to meet
product quality and to identify areas for continual improvement. The
process performance and product quality monitoring system should:
(1) Use quality risk management to establish the control strategy that
can include parameters and attributes related to drug substance and
drug product materials and components, facility and equipment
operating conditions, in-process controls, finished product
specifications, and the associated methods and frequency of
monitoring and control. The control strategy should facilitate timely
feedback / feed forward and appropriate corrective action and
preventive action;
(2) Provide the tools for measurement and analysis of parameters and
attributes identified in the control strategy, e.g., data management
and statistical tools;
(3) Analyze parameters and attributes identified in the control strategy
to verify continued operation within a state of control;
(4) Identify sources of variation affecting process performance and
product quality for potential continual improvement activities to
reduce or control variation;
(5) Include feedback on product quality from both internal and external
sources, e.g., complaints, product rejections, non-conformances,
recalls, deviations, audits and regulatory inspections and findings;
(6) Provide knowledge to enhance process understanding, enrich the
design space (where established), and enable innovative approaches
to process validation.

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 Pharmaceutical Quality System

Table I: Application of Process Performance and Product Quality

Monitoring throughout the Product Lifecycle
Development Technology Manufacturing Product
Transfer Discontinuation
Quality risk Monitoring of A well-defined Once
management and scale-up activities system for manufacturing
monitoring can provide a process ceases,
conducted preliminary performance and monitoring such
throughout indication of product quality as stability testing
development can process monitoring should should continue
be used to performance and be applied to to completion of
establish a control the successful assure the studies.
strategy for integration into performance Appropriate action
manufacturing. manufacturing. within a state of on marketed
Monitoring of control and to product should
transfer and identify continue to be
scale-up activities improvement executed
can be useful in areas. according to
further regional
developing the regulations.
control strategy.

ii) Corrective Action and Preventive Action System (CAPA)

The pharmaceutical company should have a system for implementing
corrective actions and preventive actions resulting from the
investigation of complaints, product rejections, non-conformances,
recalls, deviations, audits, regulatory inspections and findings, and
trends from process performance and product quality monitoring. A
structured approach to the investigation process should be used with
the objective of determining root cause. The level of effort and
formality of the investigation should be commensurate with the level of
risk. CAPA methodology should result in product and process
improvements and enhanced product and process understanding.

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Table II: Application of Corrective Action/Preventive Action

throughout the Product Lifecycle
Development Technology Manufacturing Product
Transfer Discontinuation
Product or CAPA can be used CAPA should be CAPA should
process as an effective used and the continue after the
variability is system for effectiveness of product is
explored. CAPA feedback, feed the actions discontinued.
methodology can forward and should be The impact on
be useful where continual evaluated. product
corrective actions improvement. remaining on the
and preventive market should be
actions are considered as
incorporated into well as other
the iterative products which
design and might be
development impacted.
process.

iii) Change Management System

Innovation, continual improvement, the outputs of process performance
and product quality monitoring and CAPA drive change. In order to
properly evaluate, approve and implement these changes, a company
should have an effective change management system. There is
generally a difference in formality of change management processes
prior to the initial regulatory submission and after submission, where
changes to the regulatory filing might be required under regional
requirements.
The change management system ensures continual improvement is
undertaken in a timely and effective manner while providing a high
degree of assurance there are no unintended consequences of the
change.
The change management system should include the following, as
appropriate for the stage of the lifecycle:
(1) Quality risk management should be utilised to evaluate proposed
changes. The level of effort and formality of the evaluation should
be commensurate with the level of risk. There should be an
assessment to determine whether a change to the regulatory filing is
required under regional requirements;
(2) All changes should be properly evaluated. Proposed changes should
be evaluated relative to the marketing authorisation, including
design space, where established, and / or current product and
process understanding. As stated in ICH Q8, movement within the
design space is not considered a change (from a regulatory filing
perspective). However, from a pharmaceutical quality system
standpoint, all changes should be evaluated by a company’s change
management system;

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 Pharmaceutical Quality System

(3) Proposed changes should be evaluated by expert teams contributing

the appropriate expertise and knowledge from relevant areas, e.g.,
Pharmaceutical Development, Manufacturing, Quality, Regulatory
Affairs and Medical, to ensure the change is technically justified.
Prospective evaluation criteria for a proposed change should be set;
(4) After implementation, an evaluation of the change should be
undertaken to confirm the change objectives were achieved and that
there was no deleterious impact on product quality;
(5) Regional regulatory submission/approval requirements should be
assessed for a proposed change to a marketed product.

Table III: Application of Change Management System throughout

Product Lifecycle
Development Technology Manufacturing Product
Transfer Discontinuation

Change is an The change A formal change Any changes after

inherent part of management management product
the development system should system should be discontinuation
process and provide in place for should go
should be management and commercial through an
documented; the documentation of manufacturing. appropriate
formality of the adjustments Oversight by the change
change made to the quality unit management
management process during should provide system.
process should technology assurance of
increase as the transfer appropriate
product moves activities. science and risk
through based
development. assessments.

iv) Management Review of Process Performance and Product Quality

Management review should provide assurance that process performance
and product quality are managed over the lifecycle. Depending on the
size and complexity of the company, management review can be a
series of reviews at various levels of management and should include a
timely and effective communication and escalation process to raise
appropriate quality issues to senior levels of management for review.
(1) The management review system should include:
(a) The results of regulatory inspections and findings, audits and
other assessments;
(b) Periodic quality reviews, that can include:
(i) Measures of customer satisfaction such as customer
complaints and recalls;
(ii) Conclusions of process performance and product quality
monitoring;

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Pharmaceutical Quality System

(iii)The effectiveness of process and product changes including

those arising from corrective action and preventive actions.
(c) Any follow-up actions from previous management reviews;
(2) The management review system should identify appropriate action,
such as:
(d) Improvements to manufacturing processes and products;
(e) Provision, training and/or realignment of resources;
(f) Capture and dissemination of knowledge.

Table IV: Application of Management Review of Process Performance

and Product Quality throughout the Product Lifecycle

Development Technology Manufacturing Product

Transfer Discontinuation
Aspects of Aspects of Management Management
management management review should be review should
review can be review should be a structured include such
performed to performed to system, as items as product
ensure adequacy ensure the described above, stability and
of the product developed and should product
and process product and support continual complaints.
design. process can be improvement.
manufactured at
commercial scale.

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 Pharmaceutical Quality System

4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY

SYSTEM
This section describes activities that should be conducted to manage and
continually improve the pharmaceutical quality system.

4.1 Management Review of the Pharmaceutical Quality System

Management should have a formal process for reviewing the pharmaceutical
quality system on a periodic basis. The review should include:
i) Measurement of achievement of pharmaceutical quality system
objectives;
ii) Assessment of Key Performance Indicators that can be used to monitor
the effectiveness of processes within the pharmaceutical quality system,
such as:
(1) Complaint, deviation, CAPA and change management
processes;
(2) Self-assessment processes including audits;
(3) External assessments such as regulatory inspections and
findings and customer audits.

4.2 Monitoring of Internal and External Factors Impacting the

Pharmaceutical Quality System
Factors monitored by management can include:
i) Emerging regulations, guidance and quality issues that can impact the
Pharmaceutical Quality System;
ii) Innovations that might enhance the pharmaceutical quality system;
iii) Changes in business strategies and objectives.
4.3 Outcomes of Management Review and Monitoring
The outcome of management review of the pharmaceutical quality system and
monitoring of internal and external factors can include:
i) Improvements to the pharmaceutical quality system and related
processes;
ii) Allocation or reallocation of resources and/or personnel training;
iii) Revisions to quality policy and quality objectives, as appropriate;
iv) Timely and effective communication of the results of the management
review and actions, including escalation of appropriate issues to senior
management.

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5. GLOSSARY
ICH and ISO definitions are used in ICH Q10 where they exist. For the purpose
of ICH Q10, where the words “requirement”, “requirements” or “necessary”
appear in an ISO definition, they do not necessarily reflect a regulatory
requirement. The source of the definition is identified in parenthesis after the
definition. Where no ICH or ISO definition was available, an ICH Q10 definition
was developed.

Capability of a Process:
Ability of a process to realise a product that will fulfil the requirements of that
product. The concept of process capability can also be defined in statistical
terms. (ISO 9000-2005)

Change Management:
A systematic approach to proposing, evaluating, approving, implementing and
reviewing changes. (ICH Q10 EWG)
Continual Improvement:
Recurring activity to increase the ability to fulfil requirements. (ISO 9000-2005)
Control Strategy:
A planned set of controls, derived from current product and process
understanding, that assures process performance and product quality. The
controls can include parameters and attributes related to drug substance and
drug product materials and components, facility and equipment operating
conditions, in-process controls, finished product specifications, and the
associated methods and frequency of monitoring and control. (ICH Q10 EWG)

Corrective Action:
Action to eliminate the cause of a detected non-conformity or other
undesirable situation. (ISO 9000-2005)
Design Space:
The multidimensional combination and interaction of input variables (e.g.,
material attributes) and process parameters that have been demonstrated to
provide assurance of quality. (ICH Q8)
Enabler:
A tool or process which provides the means to achieve an objective. (ICH Q10
EWG)

Key Performance Indicators:

Metrics used to quantify quality objectives to reflect the performance of an
organization, process or system. (ICH Q10 EWG).
Innovation:
The introduction of new technologies or methodologies to pharmaceutical
development and manufacturing. (ICH Q10 EWG)

Knowledge Management:
Systematic approach to collecting, analyzing, storing, and disseminating
information related to products, processes and components. (ICH Q10 EWG)

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 Pharmaceutical Quality System

Outsourced Activities:
Activities conducted by a contract acceptor under contract with a contract
giver. (ICH Q10 EWG)

Pharmaceutical Quality System:

Management system to direct and control a pharmaceutical company with
regard to quality. (ICH Q10 EWG based upon ISO 9000-2005)
Preventive Action:
Action to eliminate the cause of a potential non-conformity or other
undesirable potential situation. (ISO 9000-2005)

Product Realisation:
Achievement of a product with the quality attributes appropriate to meet the
needs of patients, health care professionals, regulatory authorities (including
compliance with marketing authorisation) and internal customers. (ICH Q10
EWG)
Quality:
The degree to which a set of inherent properties of a product, system or
process fulfills requirements. (ICH Q9)

Quality Manual:
Document specifying the quality management system of an organization. (ISO
9000-2005)
Quality Objectives:
A means to translate the quality policy and strategies into measurable
activities. (ICH Q10 EWG)

Quality Planning:
Part of quality management focused on setting quality objectives and
specifying necessary operational processes and related resources to fulfill the
quality objectives. (ISO 9000-2005)

Quality Policy:
Overall intentions and direction of an organization related to quality as
formally expressed by senior management. (ISO 9000-2005)
Quality Risk Management:
A systematic process for the assessment, control, communication and review
of risks to the quality of the drug (medicinal) product across the product
lifecycle. (ICH Q9)
Senior Management:
Person(s) who direct and control a company or site at the highest levels. (ICH
Q10 EWG based on ISO 9000-2005 definition for “Top Management”)

State of Control:
A condition in which the set of controls consistently provides assurance of
continued process performance and product quality. (ICH Q10 EWG)

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Pharmaceutical Quality System

Annex 1

Potential Opportunities to Enhance Science and Risk Based

Regulatory Approaches *

*Note: This annex reflects potential opportunities to enhance regulatory

approaches. The actual regulatory process will be determined by
region.

Scenario Potential Opportunity

1. Comply with GMPs Compliance – status quo
2. Demonstrate effective Opportunity to:
pharmaceutical quality system,
• increased use of risk-based
including effective use of quality
approaches for regulatory
risk management principles (e.g.,
inspections
ICH Q9 and ICH Q10).
3. Demonstrate product and process Opportunity to:
understanding, including effective
• facilitate science-based
use of quality risk management
pharmaceutical quality
principles (e.g., ICH Q8 and ICH
assessment;
Q9).
• enable innovative approaches
to process validation;
• establish real-time release
mechanisms.
4. Demonstrate effective Opportunity to:
pharmaceutical quality system
• increased use of risk-based
and product and process
approaches for regulatory
understanding, including the use
inspections;
of quality risk management
principles (ICH Q8, ICH Q9 and • facilitate science-based
ICH Q10). pharmaceutical quality
assessment;
• optimize science and risk-
based post-approval change
processes to maximize benefits
from innovation and continual
improvement;
• enable innovative approaches
to process validation;
• establish real-time release
mechanisms.

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