1 of 48 Quality System Model ICH Q10. 2 of 48 Agenda What is ICH Q10 History Why do we need a ‘modern effective Quality System’? The elements and enablers.
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Quality System ModelICH Q10
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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 Pfizer’s Quality System
Review the website
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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.
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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
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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
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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
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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
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Pharmaceutical Quality System
GMP
TechnologyTransfer
PharmaceuticalDevelopment
CommercialManufacturing
Investigational Products
Management Responsibilities
Process Performance & Product Quality Monitoring SystemCorrective Action/Preventive Action (CAPA) System
Change Management SystemManagement Review
Knowledge Management
Quality Risk Management
Quality System
Elements
Enablers
ProductDiscontinuation
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An Effective Quality System
GMPs
Management Responsibility
Elements - Continual Improvement
Enablers – Knowledge and Risk Management
Lifecycle approach
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An Effective Quality System
GMPs
Management Responsibility
Elements - Continual Improvement
Enablers – Knowledge and Risk Management
Lifecycle approach
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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
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Management Responsibilities
Management Commitment
Quality Policy
Quality Planning
Resource Management
Internal Communication
Management Review
Outsourced Activities
Change in Product Ownership
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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
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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
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Quality Policies
Comprehensive and Balanced
Flexibility/adaptability defined is consistent
Interconnectivity of a Quality System requires a comprehensive approach in the design
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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An Effective Quality System
GMPs
Management Responsibility
Elements - Continual Improvement
Enablers – Knowledge and Risk Management
Lifecycle approach
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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
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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
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Key to an Effective Quality System
GMPs
Management Responsibility
Continual Improvement
Knowledge Management
Quality Risk Management
Lifecycle approach
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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
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Pharmaceutical Quality System
GMP
TechnologyTransfer
PharmaceuticalDevelopment
CommercialManufacturing
Investigational Products
Management Responsibilities
Process Performance & Product Quality Monitoring SystemCorrective Action/Preventive Action (CAPA) System
Change Management SystemManagement Review
Knowledge Management
Quality Risk Management
Quality System
Elements
Enablers
ProductDiscontinuation
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Pharmaceutical Development Stage
PharmaceuticalDevelopment
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
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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
TechnologyTransfer
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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.
CommercialManufacturing
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Product Discontinuation Stage
Manage the terminal stage of the product lifecycle using a pre-defined approach – product complaint
management – stability studies
documentation
ProductDiscontinuation
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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
GMP
TechnologyTransfer
PharmaceuticalDevelopment
CommercialManufacturing
Investigational Products
ProductDiscontinuation
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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
TechnologyTransfer
PharmaceuticalDevelopment
CommercialManufacturing
ProductDiscontinuation
Management Controls
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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
PharmaceuticalDevelopment
Application of Quality System Elements
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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
Application of Quality System Elements
TechnologyTransfer
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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
Application of Quality System Elements
CommercialManufacturing
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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
Application of Quality System Elements
ProductDiscontinuation
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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
TechnologyTransfer
PharmaceuticalDevelopment
CommercialManufacturing
ProductDiscontinuation
Knowledge Management
Quality Risk Management
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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
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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
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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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