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Title: Quality%20System%20Model%20ICH%20Q10

Quality System Model ICH Q10
  • What is ICH Q10
  • History
  • Why do we need a modern effective Quality
  • The elements and enablers of a Quality System
  • Model of Pfizers Quality System
  • Review the website

Pharmaceutical Quality System
  • The ICH Q10 document on Pharmaceutical Quality
    System was recommended for adoption to the
    regulatory bodies of the EU, Japan and USA, June
  • The document establishes a tripartite guideline
    describing a model for an effective quality
    management system a management system to direct
    and control a pharmaceutical company with regard
    to quality.
  • The specifics of a pharmaceutical quality
    system vary depending with the stage of the
    product lifecycle, but the
    overall principles and components
    are the same.

Evolution of regional GMPs 1970s
Evolution of ISO 9000 approaches 1980s
FDA 21st Century initiative 2002
ICH Quality Vision / Q8, Q9 2003
Guidance for Industry - Quality System Approach to Pharmaceutical cGMP Regulations 2006
ICH Q10 Pharmaceutical Quality System 2008
Comprehensive Model
  • Based on International Standards Organization
    (ISO) quality concepts
  • Includes applicable GMP regulations
  • Complements both
  • ICH Q8 Pharmaceutical Development,
  • ICH Q9 Quality Risk Management
  • Not intended to create new expectations beyond
    current regulatory environment

A Modern Effective Quality System?
  • Good business practice!
  • Significant changes in external business
  • Fewer new products / blockbusters
  • Reduced margins / greater competition / low-cost
  • Focus of efficient, effective organizations
  • Lean processes
  • Pharmaceutical industry is behind other
    industries in Quality Management philosophies /
  • Marketed products ARE safe and efficacious
  • BUT costs of quality are high
  • Often reactive, not designed-in / preventative

Why do we need a Modern Effective Quality
  • Implementation should
  • Facilitate innovation and continual improvement
  • Inflexible regulatory environment
  • Focus on Compliance, not Science and Risk-Based
  • Industry margins did not provide drive for change
  • Strengthen the link between pharmaceutical
    development and manufacturing
  • GMPs do not provide a full modern Quality
  • Originated in 1970s incremental additions
  • ISO Quality Management thinking not embedded
  • Need to be complemented with Q8 and Q9

Pharmaceutical Quality System
An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

Management Responsibilities
  • Essential component of a Quality System
  • Not just about compliance
  • Visible leadership to establish and maintain a
    company wide culture and commitment to Quality
    and improvement
  • Monitor performance of the Quality System for
    both internal and outsourced activities
  • Quality can not be owned only
    by the Q Unit
  • Management is accountable
  • But independent assessments are key

Management Responsibilities
  • Management Commitment
  • Quality Policy
  • Quality Planning
  • Resource Management
  • Internal Communication
  • Management Review
  • Outsourced Activities
  • Change in Product Ownership

Management Commitment
  • Signed Quality Commitments are commonplace and
    are not indicative of Management Commitment
  • What is Indicative?
  • Plant Managers aware of the issues
  • Management Team that works together
  • Quality as a Trusted Partner

Clear Roles, Responsibilities, Processes
  • Quality Policy Sets the standards and direction
    of organization
  • Quality Planning Converts into objectives
  • Resources Allocations and competence
  • Communication Quality items to appropriate
  • Management Reviews
  • Product and Process performance
  • Quality System performance

Quality Policies
  • Comprehensive and Balanced
  • Flexibility/adaptability defined is consistent
  • Interconnectivity of a Quality System requires a
    comprehensive approach in the design

Quality Plans
  • Written Quality Plans are becoming more common
  • What is Indicative?
  • Quality Planning Process is dynamic
  • Defined process for evaluating issues to bring
    into the quality planning process.
  • Tracking progress against an agreed upon Quality
  • Adequate resources are made available

Resource Management
  • Adequate resources are made available
  • Resources include time, money, equipment and
  • What is Indicative?
  • Clear prioritization of resources in line with
  • Reasonable number of projects with
  • Realistic commitment time frames

Internal Communication
  • Issues will occur
  • Escalation of issues, actions, decisions and
  • What is Indicative?
  • Trusting relationship between manufacturing
    quality assurance
  • Understanding of why timeliness is important
  • Communication uses defined processes and is
  • Escalation of issue is not viewed as punitive
  • The Operations Team is wholly accountable
  • Adequate resources are made available

Management Review
  • Grounded in the device regulations, periodic
    Management Reviews are becoming more common
  • What is Indicative?
  • Linkage between Quality Plan and Management
  • Linage between Key Quality Indicators
  • In a hierarchal company, how information flows
  • Depth and frequency of Reviews
  • Attendance at the Management Review
  • How is the information used?
  • Opportunity to align priorities and resources
  • Not punitive

Outsourced Activities and Purchased Materials
  • Pharmaceutical firm (i.e., Management) is
    ultimately responsible to assure processes are in
  • Process must be in place to
  • Assess suitability of contractors / suppliers
    before use
  • Ensure use of approved suppliers and a defined
    supply chain
  • Define responsibilities and communication
    processes for quality related activities
  • Review performance and make improvements

An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Process Performance and Product Quality
  • Corrective Action / Preventive Action
  • Change Management
  • Management Review
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

Continual Improvement
  • Continuous Improvement of product quality is a
    key objective of the quality system, irrespective
    of the stage of the lifecycle.
  • Four specific elements of the quality system
    support achieving continuous improvement
  • Process performance and product quality
  • Corrective action and preventative action
  • Change management
  • Management review of process
  • performance and product quality

Product Quality and Process Performance
  • Use knowledge, Quality by Design, Product and
    Process understanding and QRM to set Control
  • What and when to monitor / measure / test
  • Based on critical product quality attributes and
    critical process parameters to deliver them
  • Reduce and control variation to appropriate
  • Confirm and maintain a state of control
  • Feed-back and Feed-forward loops
  • Drive continual improvement
  • Continual verification

CAPA System
  • Investigation of non-conformances
  • Reactive ? deviations, rejections, complaints,
    recalls, observations from audits and inspections
  • Proactive ? feedback from trends
  • Structured investigations to seek root cause
  • Use QRM to ensure degree and formality is
    commensurate with level of risk
  • Should result in enhanced knowledge and
  • Not just reacting to non-conformances
  • Focus on preventative actions
  • Need effective tracking / follow up processes

Change Management System
  • Change can be good!
  • Proactively driven by outputs from monitoring /
    trending / improvement / innovation
  • Not just by reacting to problems
  • Use expert teams and knowledge to evaluate and
    set success criteria
  • Use QRM commensurate with level of risk
  • Consider impact on regulatory filings
  • Undertake in timely and effective way and tracked
  • Assure no unintended consequences

Management Review
  • Process Performance and Product Quality
  • Results from inspections and assessments
  • Periodic quality reviews
  • Customer satisfaction complaints, recalls
  • Conclusions of process performance and product
    quality monitoring
  • Effectiveness of process and product changes
  • Appropriate actions
  • Improvements to manufacturing processes
  • Training and/or realignment of resources
  • Capture and share knowledge

Continual Improvement of the Quality System
  • Assessment of the Quality System against
  • Internal factors (audits, CAPAs, complaints,
    recalls, etc.)
  • External factors (regulatory inspectional
  • Emerging regulations
  • New technology
  • Change in business strategies
  • Outcomes of the Assessment
  • Improvements communicated throughout a business
  • Resource reallocation
  • Changes in policies, practices

An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

Knowledge Management
  • Systematic and lifecycle approach to acquiring,
    analyzing, storing and disseminating knowledge on
    products, processes, components
  • Provides the basis for science and risk-based
    approaches in the Quality System
  • Product and process development
  • Manufacturing
  • Change management
  • Continual improvement

Quality Risk Management (Q9)
  • Essential, integrated part of Quality System
  • The evaluation of the risk to quality should be
    based on scientific knowledge and ultimately link
    to the protection of the patient and
  • The level of effort, formality and documentation
    of the quality risk management process should be
    commensurate with the level of risk
  • Proactive use to identify and control risk
  • Support decision through lifecycle
  • Integrate into key parts of Quality System
  • e.g., change management, CAPA, GMPs Validation,
  • Help set meaningful specification / control
    parameters to ensure product quality
    control requirements are met

Key to an Effective Quality System
  • GMPs
  • Management Responsibility
  • Continual Improvement
  • Knowledge Management
  • Quality Risk Management
  • Lifecycle approach

Lifecycle Approach
  • Holistic and cover the product lifecycle
  • Design and Development
  • Manufacturing
  • Withdrawal
  • Challenges and removes some traditional
    organizational silos
  • Within industry
  • Within Regulatory Agencies
  • With outsourcing partners
  • Application of Quality System Elements at
    each stage of the Product Lifecycle

Pharmaceutical Quality System
Pharmaceutical Development Stage
  • Design a product and its manufacturing process to
    consistently deliver the intended performance and
    meet the needs of patients, health-care
    professionals, and regulatory authorities
  • Develop knowledge of product and processes
  • Utilize Quality Risk Management
    principles to identify and
    control risk to
    product quality

Technology Transfer Stage
  • Transfer product and process knowledge between
    development and manufacturing or between
    manufacturing units.
  • Develop further knowledge
  • Refine Quality Risk Management
    and control strategies

Commercial Manufacturing Stage
  • Provide product with appropriate quality
    attributes consistently in a state of control and
    facilitating continual improvement.
  • Continually expand product and process knowledge
  • Adjust the Quality Risk
    Management and control
    strategy as

Product Discontinuation Stage
  • Manage the terminal stage of the product
    lifecycle using a pre-defined approach
  • product complaint management
  • stability studies documentation

GMPs over the Product Lifecycle
  • Compliance with applicable GMPs is the foundation
    of the quality system
  • The intended use and market of any material
    produced during the lifecycle must be understood
    and the appropriate GMPs must be met
  • Applicable GMPs must be incorporated into the
    quality system for each stage of the lifecycle
  • Documentation
  • Quality Unit Responsibilities
  • Facilities and Equipment

Management Controls - Product Lifecycle
  • Essential over all stages of Product Lifecycle
  • Includes Management Commitment, Policy and
    Planning, Resource Management, Review and
  • Extends to management controls of outsourced

  • Monitoring
  • Use to provide data and knowledge
  • CAPA
  • Use methodology to identify and implement
  • Change Management
  • Change is inherent part of this phase
  • Change must be documented
  • Increase formality as development progresses
  • Management Review
  • Use to ensure the adequacy of product and process

  • Monitoring
  • Use to provide indication of how process performs
    in manufacturing
  • CAPA
  • Used to make improvements to development and to
    commercial manufacturing
  • Change Management
  • Proactively manage change and thoroughly
  • Management Review
  • Use to ensure the developed process can be
    manufactured at scale

  • Monitoring
  • Well-defined monitoring of process performance
    product quality to assure performance within a
    state of control
  • CAPA
  • CAPA methodology must be used and the
    effectiveness evaluated
  • Change Management
  • Formal change management must be used
  • Must have oversight by the quality unit
  • Management Review
  • A structured review which identifies and
    supports continual improvement

  • Monitoring
  • Relevant monitoring should continue (e.g.,
    completion of stability studies, and product
    compliant analysis)
  • CAPA
  • Should be used to determine and address any
    impact on product remaining on the market and on
    any other products
  • Change Management
  • Should continue for any appropriate changes
  • Oversight by quality unit
  • Management Review
  • Continue reviews and include such activities as
    stability and complaints

Enablers Over the Product Lifecycle
  • Knowledge increases throughout the product
    lifecycle and must be captured, transferred and
    used systematically
  • Quality Risk Management provides proactive
    approach to identifying and controlling risks
    throughout the lifecycle

Framework of a Quality System
  • Achieve Product Realization
  • From the start of an idea for a product, to the
    culmination of the product available for the
  • Manufacturing and release of finished goods so
    that prodcut is available for patients
  • Establish and Maintain a State of Control
  • Effective monitoring control systems are in
    place which assure continued process performance
    and prodcut quality
  • A confidence when scheduling production, product
    will be available according to planned dates.
  • Facilitate Continual Improvement
  • Reducing project and process variability
  • Looking for areas of improvement not
  • self-evident but important

  • The Quality System defines our Quality Culture
  • Defines the responsibilities and authorities
  • Defines communication models to all levels in the
  • Provides a clear governance model defining how
    quality decisions are made
  • Monitors to assure necessary resources are
    available for completion of quality plans
  • Assures alignment of the quality
    objectives with the business strategy
  • Makes life easier

Pfizer Quality System Model
  • International Conference on Harmonization,
    Harmonized Tripartite Guideline, Pharmaceutical
    Quality System, ICH Q10, Step 4, 04June2008
  • Kaufman, Zena G., Divisional VP, Quality Center
    of Excellence, Abbott, Considerations for
    Designing a Pharmaceutical Quality System, Nov
  • Allen, Barbara, Director, Global Quality Systems,
    Eli Lilly and Company, Quality Systems over the
    Product Lifecycle, Nov 2008
  • Wilkinson, Neil, David Begg Associates, The
    Elements of a Modern Effective Pharmaceutical
    Quality System, Nov 2008
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