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1. ICH Q8 - Pharmaceutical Development (2006; revised 2009)• describes the suggested contents for the pharmaceutical development section of a
regulatory submission in the ICH M4 common technical document (CTD) format; • indicates areas where the provision of greater understanding of pharmaceutical and
manufacturing sciences can create a basis for flexible regulatory approaches.• Q8(R) includes concepts of Quality by Design (QbD) and examples of design space.
2. ICH Q9 – Quality Risk Management (2006)• provides principles and examples of tools for quality risk management that can be
applied to all aspects of pharmaceutical quality throughout the lifecycle of drugsubstances, drug products, and biological and biotechnological products;
• intended to enable regulators and industry to make more effective and consistent risk based decisions.
3. ICH Q10 – Pharmaceutical Quality System (2009)• intended to provide a comprehensive approach to an effective pharmaceutical quality
system that is based on ISO concepts, includes applicable GMP regulations andcomplements ICH guidance on Q8 and Q9.
Guidance for Industry: Q10 Pharmaceutical Quality System (April 2009),Process Performance and Product Quality Monitoring System 3.2.1 -
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.
• Use quality risk management to establish the control strategy.
• Provide the tools (e.g., data management and statistical tools) for measurement and analysis of parameters and attributes identified in the control strategy
• Verify continued operation within a state of control
• Identify sources of variation affecting process performance and product quality for potential continual improvement activities.
• Include feedback on product quality from both internal and external sources, e.g. complaints, product rejections, non-conformances, recalls, deviations, audits and inspection inspections and findings;
Regulatory Landscape and Need for Integrated Product Quality Management
Health Authorities expecting ICH Q8-10 implementation
EU moving in direction of making ICH Q10 elements enforceable asdirectivesMore emphasis on role of managementQRM and KM are expected to be integrate in PQSPQS is expected to be applied consistently across a company
Establish and Maintain State of Control(Systemic, Comprehensive and Global)
• “It is our [FDA] expectation that firms take a systematic approach to correcting and complying with CGMP to ensure the identity, strength, quality, and purity of their drug products.”
• “In your response to this [warning] letter, please include an explanation of how you intend to implement, support, and sustain acomprehensive quality system at your firm that is consistent with CGMP.”
• “It appears that you have not taken a global quality systems approach to corrective actions at your firm…It is your responsibility to review your operations at all facilities and apply appropriate corrective actions to address deficiencies present at multiple sites.”
Source: 2010 FDA Warning Letters, at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
• “It is our expectation that firm’s senior management ensure a systematic approach to designing their products, processes, and quality systems, and require that deviations and flaws are promptly identified and corrected to assure the identity, strength, quality, and purity of their drug products.”
• “Be advised that FDA expects that your corporate management will undertake a comprehensive evaluation of manufacturing operations to ensure compliance with CGMP.”
Source: 2010 FDA Warning Letters, at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
Quality PhilosophyQuality is every patient’s right and every employee’sresponsibility. Quality provides a competitive advantage andis engrained in everything we do, from concept throughcontinuous improvement. Because our products touch humanlives, quality is the true measure of our success.
Our Prioritization Principles1. Right to Operate2. Quality Supply to Patients3. Contribution to Target
- Deliver an End to End (E2E) view of product quality for all Commercial products
- Critical to:– maintaining quality supply to patients– product consistency across sites– our right to operate
- End to End means that the product quality:– is managed throughout the product value stream– includes both API and drug product– is managed throughout Product Life Cycle (Q10 enabler-
Process Performance and Product Quality Monitoring)- Success requires knowledge transfer from Clinical to Commercial
Product Complaints• Early warning signals of product quality issues in
the field
Product Complaints• Early warning signals of product quality issues in
the fieldProduct Assessment & Trending• Proactive assessment of product quality
attributes across the manufacturing process
Product Assessment & Trending• Proactive assessment of product quality
attributes across the manufacturing process
Product Quality Stewards• Single point of Contact for Quality to key stakeholders• Routine health assessment of product to address trends• Planning provides foresight and proactive approach
Product Quality Stewards• Single point of Contact for Quality to key stakeholders• Routine health assessment of product to address trends• Planning provides foresight and proactive approach
QC testing network support• Harmonized approach to test method execution & support• Scalability & flexibility to balance test workload across network
QC testing network support• Harmonized approach to test method execution & support• Scalability & flexibility to balance test workload across network
Analytical methods managementScientific rigor engrained in analytical method performanceProduct control systems based on scienceSeamless product transfers & assessment of consistency
Analytical methods managementScientific rigor engrained in analytical method performanceProduct control systems based on scienceSeamless product transfers & assessment of consistency
• Better understanding of a company’s capability and profile across a global network i.e., more assurance by regulators of consistentprocesses and global implementation;
• Companies can provide more assurance site to site for producingconsistent products and analytical procedures in a global network environment; and
• Enhanced ability for regulators to leverage shared assessments,inspections based on common standards globally for new products,changes, and site transfers.
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Design of the PQS
PQS involves IT Tools, business processes and common requirements
• Need to establish metrics including costs:InvestigationsRejects product removal actionsLabor and Time involved
• Too often the focus is on getting the product released, but not enough focus on getting to the root cause and preventing the issues from reoccurring. If conducting multiple investigations to deal with the same issues over and over again, is money really being spent wisely?
• “The Cost of Quality quantification provides a business case for well thought out preventive action."
Use of Quality Risk Management to utilize findings from inspections, audits, and trending data and to
eliminate or mitigate risks
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Conclusion
• PQS is the foundation for quality products
• PQS covers
All of Supply Chain from raw materials to distributionOwn production and outsourcedFrom pre-clinical through commercial to decommissioningGMPs and should be integrated with business processes and supported by tools
• For multi site companies PQS consistency is achieved through standardization, common IT tools and management oversight
• ICH Q10 has increased expectations to Senior Management within PQS and to using the enablers QRM & Knowledge Management