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Quality%20System%20Model%20ICH%20Q10

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


1
Quality System Model ICH Q10
2
Agenda
  • What is ICH Q10
  • History
  • Why do we need a modern effective Quality
    System?
  • The elements and enablers of a Quality System
  • Model of Pfizers Quality System
  • Review the website

3
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
    2008.
  • 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.

4
History
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
5
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

6
A Modern Effective Quality System?
  • Good business practice!
  • Significant changes in external business
    environment
  • Fewer new products / blockbusters
  • Reduced margins / greater competition / low-cost
    sources
  • Focus of efficient, effective organizations
  • Lean processes
  • Pharmaceutical industry is behind other
    industries in Quality Management philosophies /
    practices
  • Marketed products ARE safe and efficacious
  • BUT costs of quality are high
  • Often reactive, not designed-in / preventative

7
Why do we need a Modern Effective Quality
System?
  • Implementation should
  • Facilitate innovation and continual improvement
  • Inflexible regulatory environment
  • Focus on Compliance, not Science and Risk-Based
    approach
  • Industry margins did not provide drive for change
  • Strengthen the link between pharmaceutical
    development and manufacturing
  • GMPs do not provide a full modern Quality
    System
  • Originated in 1970s incremental additions
  • ISO Quality Management thinking not embedded
  • Need to be complemented with Q8 and Q9

8
Pharmaceutical Quality System
9
An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

10
An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

11
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

12
Management Responsibilities
  • Management Commitment
  • Quality Policy
  • Quality Planning
  • Resource Management
  • Internal Communication
  • Management Review
  • Outsourced Activities
  • Change in Product Ownership

13
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

14
Clear Roles, Responsibilities, Processes
  • Quality Policy Sets the standards and direction
    of organization
  • Quality Planning Converts into objectives
    plans
  • Resources Allocations and competence
  • Communication Quality items to appropriate
    audience
  • Management Reviews
  • Product and Process performance
  • Quality System performance

15
Quality Policies
  • Comprehensive and Balanced
  • Flexibility/adaptability defined is consistent
  • Interconnectivity of a Quality System requires a
    comprehensive approach in the design

16
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
    Plan
  • Adequate resources are made available

17
Resource Management
  • Adequate resources are made available
  • Resources include time, money, equipment and
    people
  • What is Indicative?
  • Clear prioritization of resources in line with
  • Reasonable number of projects with
  • Realistic commitment time frames

18
Internal Communication
  • Issues will occur
  • Escalation of issues, actions, decisions and
    impact
  • What is Indicative?
  • Trusting relationship between manufacturing
    quality assurance
  • Understanding of why timeliness is important
  • Communication uses defined processes and is
    transparent
  • Escalation of issue is not viewed as punitive
  • The Operations Team is wholly accountable
  • Adequate resources are made available

19
Management Review
  • Grounded in the device regulations, periodic
    Management Reviews are becoming more common
  • What is Indicative?
  • Linkage between Quality Plan and Management
    Reviews
  • 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

20
Outsourced Activities and Purchased Materials
  • Pharmaceutical firm (i.e., Management) is
    ultimately responsible to assure processes are in
    place
  • 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

21
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

22
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
    monitoring
  • Corrective action and preventative action
  • Change management
  • Management review of process
  • performance and product quality

23
Product Quality and Process Performance
  • Use knowledge, Quality by Design, Product and
    Process understanding and QRM to set Control
    Strategy
  • 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
    levels
  • Confirm and maintain a state of control
  • Feed-back and Feed-forward loops
  • Drive continual improvement
  • Continual verification

24
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
    improvement
  • Not just reacting to non-conformances
  • Focus on preventative actions
  • Need effective tracking / follow up processes

25
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

26
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

27
Continual Improvement of the Quality System
  • Assessment of the Quality System against
  • Internal factors (audits, CAPAs, complaints,
    recalls, etc.)
  • External factors (regulatory inspectional
    findings)
  • Emerging regulations
  • New technology
  • Change in business strategies
  • Outcomes of the Assessment
  • Improvements communicated throughout a business
  • Resource reallocation
  • Changes in policies, practices

28
An Effective Quality System
  • GMPs
  • Management Responsibility
  • Elements - Continual Improvement
  • Enablers Knowledge and Risk Management
  • Lifecycle approach

29
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

30
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,
    etc.
  • Help set meaningful specification / control
    parameters to ensure product quality
    control requirements are met

31
Key to an Effective Quality System
  • GMPs
  • Management Responsibility
  • Continual Improvement
  • Knowledge Management
  • Quality Risk Management
  • Lifecycle approach

32
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

33
Pharmaceutical Quality System
34
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

35
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

36
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
    needed.

37
Product Discontinuation Stage
  • Manage the terminal stage of the product
    lifecycle using a pre-defined approach
  • product complaint management
  • stability studies documentation

38
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

39
Management Controls - Product Lifecycle
  • Essential over all stages of Product Lifecycle
  • Includes Management Commitment, Policy and
    Planning, Resource Management, Review and
    Communication
  • Extends to management controls of outsourced
    operations

40
  • Monitoring
  • Use to provide data and knowledge
  • CAPA
  • Use methodology to identify and implement
    improvements
  • 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
    design

41
  • 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

42
  • 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

43
  • 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

44
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

45
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
    patients.
  • 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

46
Summary
  • The Quality System defines our Quality Culture
  • Defines the responsibilities and authorities
  • Defines communication models to all levels in the
    organization
  • 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

47
Pfizer Quality System Model
48
References
  • 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
    2008
  • 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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